CHAPTER 6 PREVENTION OF POSTNATAL DEPRESSION

Transcription

1 CHAPTER 6 PREVENTION OF POSTNATAL DEPRESSION 6.1 The purpose of prevention approaches The purpose of preventive interventions is to decrease the distress and disruption of postnatal depression, reduce the associated personal, social and economic costs, and utilise the opportunity for mental health promotion. The first postnatal year is recognised as a critical period because of the possible long-term consequences of postnatal depression for the women, their partners, the infant and other children (Cox, 1989; Murray, 1992; Holden, 1996). Preventive approaches potentially offer significant gains in both the present and future. However, very limited research of interventions designed to prevent the onset or decrease the severity of postnatal depression has been published. Nevertheless, postnatal depression is suited to prevention strategies (Wisner & Wheeler, 1994), because: the onset is preceded by a clear marker (birth); there is a defined period of highest risk for onset (the first three months after delivery); a high-risk sample can be identified by screening for previous affective history and current social factors; and pregnant women and recent mothers have frequent antenatal and postnatal contact, which would enable health professionals to detect risk factors and implement prevention programs. Several researchers have encountered problems recruiting women and their partners to participate in postnatal depression research (Appleby & Whitton, 1993), and the attrition rate from prevention studies is particularly high (Elliott et al., 1988; Stamp et al., 1995; Whitton et al., 1996a). These problems may be related to the women s beliefs that the aetiology of postnatal depression is associated with parenting rather than mental illness and they may interpret depressive symptoms as fatigue or frustration. Hesitation in seeking professional assistance, unless there is a personal or family history of affective disorder, is also evident in the reluctance to join prevention studies (McIntosh, 1993; Whitton et al., 1996b). 6.2 Issues and definitions in prevention It has been suggested that prevention in the mental health field has been delayed unnecessarily because current research regarding the aetiology of depression is not definitive (NHMRC, 1993). Preventive interventions are determined by theoretical models (Elliott, 1989a; Ussher, 1992; Walsh & McPhee, 1992; Sharp, 1996), and biopsychosocial models are based on multiple and interactive components that may be amenable to preventive investigation. Models must take account of complex theories of postnatal depression that include both biological factors, such as genetic endowment or predisposition to depression (possibly indicated by a family history of mood disorder) and psychosocial factors such as recent major life events, current stressors, lack of support, physical exhaustion, personality characteristics, and negative cognitive style (Elliott, 1989a; Morse, 1993). Prevention of postnatal depression 129

2 Specific knowledge about potentially modifiable risk factors and protective factors that affect the development of postnatal depression is essential to decide the nature and targets of prevention strategies. However, some factors cannot be directly modified by the individual (e.g. age, ethnicity, gender, and family history; Mrazek & Haggerty, 1994). While there is some consensus about the risk factors most likely to influence the development of postnatal depression, translating known risk factors into predictive screening protocols and devising appropriate prevention programs is not as clear (Appleby & Whitton, 1993; Cooper et al., 1996). Complex interactions of biopsychosocial risk factors with individual variations must be considered when planning intervention programs and this means that one single approach will not suit all women. Other requirements in developing preventive approaches include (Lorion, 1991): establishing the base rate occurrence of a disorder from clinical trials or epidemiological data, and acknowledging that everyone with risk factors will not necessarily develop the disorder; determining the predictive accuracy of risk factor screening procedures used in selecting intervention participants or research subjects so that vulnerable populations are specifically identified; awareness that screening for vulnerability might exclude people who do not have certain risk factors and might still develop problems or benefit from the intervention; devising preventive intervention programs that are brief enough to be acceptable, long enough to achieve lasting benefits, intensive enough to have an effect, and are user friendly and not too expensive; ensuring large long-term prospective samples are organised to trial preventive interventions and assess outcomes with regular monitoring and follow-up, having a wide range of intended outcomes including decreasing the influence of risk factors, reducing specific situational stresses, and promoting mental health, not just preventing the onset of postnatal depression; and recognising that non-compliance with intervention strategies and attrition of participants are major problems, however those who decline enrolment or withdraw from involvement may be those at the greatest risk. 130 Postnatal depresssion A systematic review of published scientific literature to 1999

3 Table 6.1 Biopsychosocial factors in depression Predisposing Precipitating Maintaining Biological family history of depression hormonal changes following neurotransmitter imbalance personal history of depression delivery hormonal changes low IQ caesarean section (breastfeeding, (these factors also have psychological breastfeeding menstruation) relevance) extreme fatigue Psychological poor relationship with own parents limited coping strategies poor sense of self low self-esteem feelings of failure and dependent personality negative cognitive style disappointment cognitive vulnerability anxious, worrier perfectionist personality traits Social feeling trapped or out of control negative perception of labour and delivery depressed parents during childhood stressful life events chronic stressors loss or prolonged separation from unemployment or excessive housing parents or spouse work demands finances chronic work or marital difficulties financial constraints employment poor social support or living social and geographical relationships in poverty isolation no confidante single parenthood marital separation recent bereavement Prevention can be divided into primary, secondary and tertiary levels and preventive interventions can be classified as universal, selective or indicated depending on the target population (Mrazek & Haggerty, 1994; Patton, 1997): universal measures must be cost beneficial for everyone in the eligible population and targeted to the whole population (e.g. all childbearing women); selective strategies are cost beneficial to a subgroup of the population who are considered to be at higher risk (e.g. women with a history of depression); and indicated approaches can be applied to asymptomatic groups who have risk factors that could justify more costly and extensive interventions (e.g. women who had a very preterm delivery by emergency caesarean section). Primary prevention reduces the incidence of disordersby preventing their development, using measures either directed at all childbearing women or at specific subgroups. The measures include a more realistic portrayal of parenting in the media, educating school children regarding the practicalities of childrearing, providing training for health professionals about the nature and effects of childbirth-related mental health problems, educating women and Prevention of postnatal depression 131

4 their partners about the practical and emotional support necessary for parenting, and providing perinatal care sensitive to psychosocial issues and vulnerability factors. Pre-conceptual counselling for couples and antenatal booking visits provide an opportunity to elicit risk factors for postnatal depression and monitor women s emotional well-being (Sharp, 1996). Health professionals are ideally placed to assess marital difficulties and the availability of support, provide information concerning postnatal depression in an acceptable way during preparation for parenting classes, and advise women and men about which symptoms to observe and act upon promptly. Secondary prevention reduces the prevalence of disorders by early identification and interventions that minimise frequency, duration and severity. This area involves the detection of women who are more vulnerable to mental health problems through screening for antenatal and postnatal risk factors, and the provision of appropriate interventions, such as preventive counselling to modify the negative and harmful effects of postnatal depression. For example, pregnant women could be allocated to a midwifery group practice within an existing obstetric service or a community-based general practice providing continuity of care during the antenatal, perinatal and postnatal periods. Midwives or maternal and child health nurses could then utilise a screening measure such as the EPDS for early identification of depressive symptoms and refer to general practitioners for further assessment, treatment and case management. General practitioners will need to incorporate multidisciplinary counselling or psychotherapy services if they have neither the time nor the specialised training to provide such services themselves (Cox, 1989; Kumar et al., 1995a). Another postnatal strategy would be to increase general practice and community nursing interventions in the first three to six months after delivery to provide monitoring, support, information and referral to specialised treatment services as necessary (Holden, 1996). Tertiary prevention involves early identification and treatment to limit the disabilitycaused by an established disorder, even though the condition has not been prevented. This includes regular antenatal and postnatal follow-up contact with women at high-risk of postnatal depression to provide support, information and effective treatment as soon as possible (Holden, 1996). Strategies may include prophylactic medication and individual or couple psychotherapy for women with a prior history of affective disorder and their partners immediately after birth or at the first sign of symptoms. Other tertiary strategies include admission to specialist day programs or inpatient facilities, involvement in group programs (e.g. treatment, support or self-help groups), parent-infant interaction programs, and linking mothers with supportive trained volunteers who make regular home visits (Pope & Watts, 1996). 6.3 Prevention of postnatal depression As mentioned, there are few publications that report preventing the onset of postnatal depression as the main outcome measure of the preventive intervention. However, there are several studies that offer useful evidence to ascertain whether limiting the influence of risk factors can decrease postnatal problems and whether strengthening protective factors reduces the prevalence of postnatal distress, anxiety or depression. 132 Postnatal depresssion A systematic review of published scientific literature to 1999

5 6.3.1 Biological interventions Biological preventive intervention studies primarily focus on postnatal depression as a physical illness with a biological aetiology (e.g. changes in hormone or neurotransmitter levels) related to the specific physiological events that accompany childbirth. There have been many claims that physical causes should be able to be identified, especially in regard to hormones (Harris, 1993; Harris et al., 1994; Harris, 1996), however, this has not been substantiated. It was concluded that the results of endocrine research in puerperal mental illness are not encouraging (George & Sandler, 1988) and the aetiology of symptoms in the postnatal period is still unclear (Ussher, 1992; Gregoire, 1995; Wisner & Stowe, 1997). There have been very few prevention studies conducted that assess biological factors such as prophylactic hormone contributions and psychotropic medications. Some biological factors are not modifiable at present (e.g. genetic) and studies in this area have used mainly tertiary prevention approaches, which should be regarded as treatment and not as prevention. Hormone concentrations There is a particularly steep rise in progesterone levels during pregnancy followed by a sharp drop in progesterone immediately post-delivery (Dalton, 1980). It is hypothesised that postnatal depression may be due to women having difficulty adequately adjusting to the marked differences between hormone levels in late pregnancy compared to the early puerperium (Dalton, 1971). Despite such assertions about the role of hormonal change in the aetiology of postnatal depression or in prophylaxis and treatment, research results have not established such links. Proponents of the hormonal approach recommend increasing and stabilising progesterone levels for both treatment and prevention of postnatal depression and puerperal psychosis (Dalton, 1980) without adequate evidence to do so (Wisner & Stowe, 1997). Furthermore, there is some evidence that progesterone may exacerbate depressive symptoms in certain women with mood disorders (Hammarback et al., 1985). The effectiveness of hormonal preventive strategies for postnatal depression has yet to be properly examined in wellcontrolled clinical trials. Further research is required in this area and to date no systematically derived data support the use of progesterone (Wisner & Stowe, 1997). Further, depot progestogen is associated with an increased risk of postnatal depression and causes suppression of endogenous 17 beta-oestradiol and progesterone secretion (Lawrie et al., 1998b). Therefore, progesterone contraceptives should be used with caution in the postnatal period, especially with women who have a history of depression. Psychotropic medication Further research is needed to determine the role of such medications in preventing postnatal depression. More studies are also required to determine the likelihood of biological preventive approaches being acceptable to subject groups (e.g. the use of medication during pregnancy and lactation or frequent invasive procedures being necessary for physiological data collection). Future studies must have well-controlled research designs including large numbers of randomly assigned subjects, comparison of their progress with matched control groups, use Prevention of postnatal depression 133

6 of standardised assessment measures, allocation of assessors who are blind to the participants group status, and analysis of the data by the original intention to treat regardless of attrition from the research groups. See Appendix 5.1 for details regarding biological prevention Psychosocial interventions Most of the psychosocial research published to date has not been specifically directed to the prevention of postnatal depression. Instead psychosocial prevention programs have targeted factors that are amenable to change such as reducing postnatal distress, enhancing parentinfant attachment and providing education about child development, improving couple communication and interactions, and increasing the availability of support. Reducing postnatal distress The most quoted psychosocial prevention study assessed the effectiveness of antenatal groups in reducing postnatal emotional upsets (Gordon & Gordon, 1960). The results suggest that such groups can help reduce emotional upset. However, the study methods were unreliable, and no diagnostic measure of postnatal depression was included. Therefore the results demonstrate that providing realistic and solution-focused antenatal care can positively influence postnatal emotional outcomes, not that postnatal depression could be prevented in this manner. In another study, the effectiveness of relaxation training in reducing postpartum distress was examined (Halonen & Passman, 1985). The women who undertook relaxation interventions reported lower postnatal distress compared to the two non-relaxation groups. However, this difference may reflect coping better with the psychological concomitants of the maternity blues, rather than a true preventive strategy for postnatal depression. The study also found that simply describing potential postpartum stressors to pregnant women does not reduce depressed mood in the maternity blues period. Exposure by discussing the realities of parenthood is not sufficient on its own and may even reduce the feelings of elation commonly occurring during the initial postnatal days. Discussion of postnatal stressors needs to be accompanied by suggested ways to diminish or manage stressful situations. Enhancing parent-infant interaction Current research in Australia is investigating the effects on infants when mothers have postnatal depression. However, there are no peer-reviewed publications yet available to outline preventive interventions specific to parent-infant interactions when mothers are depressed following childbirth. A review of postnatal nursing interventions claimed there is evidence that primiparous women benefit from structured teaching and supportive counselling programs which address their concerns, attitudes, perceptions, and role-related knowledge (Donaldson, 1991). Infant growth, development, and health may directly and indirectly benefit from interventions designed to enhance the mother s knowledge, skills and ability to foster mother-infant attachment. Although short-term interventions may demonstrate a significant positive impact 134 Postnatal depresssion A systematic review of published scientific literature to 1999

7 on maternal psychological and behavioural measures, it is more difficult to achieve measurable infant effects. There may be a time lag between the intervention directed to the mother and improved infant developmental outcomes, and the first stage of active intervention needs to continue throughout the initial six to eight weeks post-delivery (Donaldson, 1991). In this review of maternal adaptation following childbirth, it was noted that mothers involved in postnatal interventions tended to ask more questions, express more concerns, and engage more community helping resources than control mothers. This suggests that postnatal psycho-educational interventions actively stimulate maternal coping and problem solving behaviours. Seeking information, expressing concerns, and accessing resources may be positive indicators that mothers are attempting to cope with the demands and challenges of parenting, rather than indicators that mothers are not coping well (Donaldson, 1991). Improving couple communication Marital dissatisfaction is the most common presenting problem in adults seeking psychological services and approximately 50% of American and 40% of Australian marriages now end in divorce (Behrens & Sanders, 1994). The birth of an infant is a transitional period in a marital relationship and it is a high-risk time for decline in relationship adjustment. Couple satisfaction frequently decreases during early parenthood (Behrens & Sanders, 1994). Preventive programs to assist coping with parenting and relationship changes could include addressing expectations about becoming both parent and partner, beliefs about gender roles, the division of household labour, conflict resolution styles, communication patterns and maintaining intimacy. There is some evidence of benefit from such programs. Increasing availability of support There is also some evidence that providing support, such as listening visits, can lead to better obstetric outcomes and better psychosocial adjustment in mothers. A review of listening visits research has recommended that future studies need to evaluate antenatal assessment and preventive strategies for postnatal depression (Clement, 1995). For instance, research is required to measure whether increased specific community or maternal and child health nurse contacts conducted antenatally could assist in decreasing postnatal depression and improving perinatal psychological outcomes (Clement, 1995). See Appendix 5.2 for details of psychosocial prevention studies Prevention research directly targeting postnatal depression Treatment study results suggest that increased community nurse intervention in the early postnatal months could decrease the likelihood that high risk women would develop postnatal depression (Holden et al., 1989), so similar interventions might be used for prevention. In addition, previous research has used participants from the general childbearing population so the majority of these women would not be expected to develop postnatal depression. Therefore subsequent studies have sought to screen antenatal women to identify a high risk population and to apply selective prevention studies within this subgroup. Prevention of postnatal depression 135

8 A key study was published in two separate book chapters but not in a peer-reviewed journal (Elliott et al., 1998; Elliott, 1989b). It is included as the results are crucial for comparison with later research. The Leverton Scale (Leverton & Elliott, 1988) was used to identify primiparous and multiparous women who were more vulnerable to postnatal depression according to the presence of risk factors. As part of the study, 188 women were assessed antenatally and 99 were identified as being more vulnerable to postnatal depression, while 89 women were identified as being less vulnerable. Women in the more vulnerable category were then randomly assigned to the intervention group (N=48) or the control group (N=51). Each group contained matched women of similar parity and expected delivery date. The intervention consisted of 11 group sessions using a psycho-educational approach including social support strategies, promoting positive mental health, and preparation for parenthood. Five group sessions were scheduled during the pregnancy as an adjunct to antenatal classes. There were also monthly meetings held up to six months post-delivery. In addition, health visitors had been asked to make an antenatal visit in mid-pregnancy in order to establish contact and provide continuity of care and support as early as possible. Participation in the intervention program revealed important differences in attendance, with 86% of primiparous women attending an average of seven group sessions, and only 56% of multiparous women attending an average of four meetings. The researchers suggested that poor participation was influenced by the timing of meetings and the inconvenience and lack of comfort in the setting, even though creche facilities were provided. There was a trend but not significant difference in the outcome data between multiparous women who did and did not attend the intervention sessions. Therefore, their results were not analysed separately. Women were assessed using a standardised psychiatric interview (PSE) at three months postpartum, to which fixed criteria for the diagnosis of major depression could be applied in the presence of depressed mood plus at least four other specific symptoms. Women who did not meet the criteria for major depression because they had between one and three specific symptoms were deemed to have borderline depression, although this was not a formal diagnostic category. A problem with this research is that the two chapters reporting these results contain different and incomplete data and the results are difficult to follow. Another publication relating to the same sample and the same design, has reported slightly different outcomes and subject numbers (Elliott, 1989b). This version states that the prevalence of both major and borderline depression at any time in the first three postnatal months demonstrated that the more vulnerable women in the intervention group had a significantly lower rate (19%; N = 48, three major and six borderline) than the more vulnerable women in the control group (40%; N = 50, five major and 15 borderline). The prevalence of depression was also lower in the original less vulnerable group (16%, N = 90, four major and 10 borderline), which suggests that the Leverton Scale was able to detect a higher risk group of women. The researchers concluded this would appear to confirm the belief that psychosocial interventions can prevent postnatal depression. However, the analysis included both major depression and borderline depression categories, and it is not certain whether the latter group would actually meet recognised diagnostic criteria for either minor depression or adjustment disorder with depressed mood (e.g. DSM or ICD). This is a problem because the 136 Postnatal depresssion A systematic review of published scientific literature to 1999

9 significant difference between the two more vulnerable groups may actually depend on the differing rate of borderline depression, as there appears to be no significant difference in the prevalence of major depression between the groups. These results should be treated cautiously since they have not been peer-reviewed and the Leverton Scale has never been published. Differences in the data and interpretation of results between the separate publications make the results difficult to interpret. See Appendix 5.2 for details concerning prevention research Training health professionals in detection and prevention It is clear that sound scientific evidence about prevention is still lacking and such information is a vital precursor to planning comprehensive programs of preventive and early intervention in postnatal depression. However, there is some evidence that the influence of certain risk factors can be modified and that universal, selected and indicated preventive strategies could be developed and trialed on the basis of these findings. Providing adequate information and training to health professionals concerning mental health issues is essential for good patient care as many nurses and medical staff have been shown to be wary and uncomfortable about dealing with psychiatric and psychological problems (Whitehead & Mayou, 1989; Lepper et al., 1994; Oermann, 1994). There is evidence from Britain and Australia concerning the effectiveness of skills training to improve detection of and treatment for postnatal depression among health practitioners, and to assist planning and service delivery in this area (McClarey & Stokoe, 1995; Watts & Pope, 1998). Community-based consultation sessions have been held in most Australian states to ascertain consumer experiences and expectations regarding postnatal depression (e.g. Health Department of Victoria, 1990; New South Wales Health Department, 1994; Pope, 1995). These reports have all indicated that a greater emphasis needs to be placed on perinatal mental health issues, especially in training health professionals in the overall physical, psychological and social care of pregnant women and recent parents. More research is needed to identify specific interventions that reduce the occurrence of depression associated with childbirth and to recommend practical and adaptable cost-effective approaches. Primary care teams and mental health services also require specific training and skills to better recognise psychological morbidity during the first postnatal year and accurate prediction measures to assess risk amongst their client populations. When evidence is available concerning useful preventive approaches, such programs need to be endorsed and funded by government and private health and family agencies as potentially responsible and cost-effective actions. Preventive programs will require support from comprehensive mental health specialist services comprised of fully resourced multidisciplinary teams with links to primary care and community based services (Cox, 1994b). Prior service planning and liaison with community agencies to create, implement, and evaluate suitable intervention programs will be essential. See Appendix 5.2 for details of studies regarding health professional training. Prevention of postnatal depression 137

10 6.4 Summary of evidence for prevention There can be long-term consequences of postnatal depression for women, their partners, the infant and other children, therefore preventive approaches are warranted. Despite limited preventive research being currently available, postnatal depression is suitable for prevention programs because the onset is preceded by a clear marker, there is a defined period of highest risk during which a sample of women may be identified, and there is substantial antenatal and postnatal contact with health services. Problems have been encountered in recruiting and retaining participants in postnatal depression prevention research, which may be related to women s beliefs about the aetiology of postnatal depressive symptoms. Translating risk factor research results into predictive screening protocols and primary prevention programs has not been successful, as complex interactions of biopsychosocial risk factors with individual variations must be considered, and this requires further research. The effectiveness of biological methods (e.g. progesterone, oestrogen or antidepressant medication) to prevent postnatal depression needs to be properly examined in wellcontrolled clinical trials. To date, no systematically derived data is available to support the use of these approaches. Much of the psychosocial research concerning prevention of postnatal depression has targeted contributing factors such as reducing postnatal distress, enhancing parent-infant attachment, improving couple communication and interactions, and increasing the availability of support. The effectiveness of psychosocial approaches in preventing postnatal depression has not been satisfactorily demonstrated, and larger samples with well-designed studies are required. Providing training in childbirth-related mental health issues for health professionals has been shown to increase detection rates, improve patient care and may aid development of primary and secondary prevention strategies. 138 Postnatal depresssion A systematic review of published scientific literature to 1999

11 CHAPTER 7 SYSTEMATIC REVIEW OF PEER-REVIEWED TREATMENT AND PREVENTION STUDIES Comparison: Support companion in labour (prevention) Outcome: Self-esteem Study: Wolman W Outcome Expt Expt Control Control Absolute effect Time point n mean (sd) n mean (sd) size (95% CI) Day (1.80) (2.00) [-1.145, 0.055] 6 weeks (2.00) (2.80) [14.925, ] Comparison: Support companion in labour Outcome: Anxiety between time points Day 1 and 6 weeks Study: Wolman W Outcome Expt Expt Control Control Absolute effect Time point n mean (sd) n mean (sd) size (95% CI) Anxiety traits Day (0.94) (0.90) 0.40 [0.10,0.70] State anxiety Day (0.85) (1.09) [-9.82, 9.20] State anxiety 6 weeks (0.92) (1.47) [-12.79,-12.01] Systematic review of peer-reviewed treatment and prevention studies 139

12 Comparison: Antenatal Intervention (prevention) Outcome: Postnatal depression as measured by EPDS Study: Stamp G Outcome Expt Expt Control Control Absolute effect Time point n mean (sd) n mean (sd) size (95% CI) Depression 6 weeks P/N [0.26,1.83] Depression 12 weeks [0.23, 1.67] P/N Depression 6 months [0.55,4.70] P/N Comparison: Prenatal parenting education Intervention (prevention) Outcome Mean anxiety state as measured by State-Trait Anxiety Inventory (STAI) at three time points Study: Midmer D Outcome Expt Expt Control Control Absolute effect Time point n mean (sd) n mean (sd) size (95% CI) 2 nd trimester [-4.53,3.69] (12.00) (12.00) 6 weeks ) [-10.62,-1.28] P/N (12.00) (12.00) 6 months [-9.42,-0.02] P/N (12.00) (12.00) 140 Postnatal depresssion A systematic review of published scientific literature to 1999

13 Comparison: Prenatal parenting education Intervention (prevention) Outcome: Dyadic Adjustment Scale at three time points Study: Midmer D Outcome Expt Expt Control Control Absolute effect Time point n mean (sd) n mean (sd) size (95% CI) 2 nd trimester [-3.46,4.76] (12.00) (12.00) 6 weeks [2.63,11.97] P/N (12.00) (12.00) 6 months [0.82,10.22] P/N (12.00) (12.00) Comparison: Prenatal parenting education Intervention (prevention) Outcome: Postpartum Adjustment Questionnaire Study: Midmer D Outcome Expt Expt Control Control Absolute effect Time point n mean (sd) n mean (sd) size (95% CI) 6 weeks [-10.53,-1.19] P/N (12.00) (12.00) 6 months [-10.24,-0.84] P/N (12.00) (12.00) Systematic review of peer-reviewed treatment and prevention studies 141

14 Comparison: Fluoxetine plus counselling vs placebo plus counselling (treatment) Outcome: Postnatal depression as measured by administration of fluoxetine plus 1 counselling session Study: Appleby L Outcome Expt Expt Control Control Absolute effect Time point n mean (sd) n mean (sd) size (95% CI) [-15.60,-0.40] (15.00) (10.50) Comparison: Fluoxetine plus counselling vs placebo plus counselling (treatment) Outcome: Postnatal depression as measured by administration of fluoxetine plus 6 counselling sessions Study: Appleby L Outcome Expt Expt Control Control Absolute effect Time point n mean (sd) n mean (sd) size (95% CI) [-9.01,-4.01] (11.40) (10.10) Comparison: Fluoxetine plus counselling vs placebo plus counselling (treatment) Outcome: Postnatal depression as measured by administration of placebo plus 1 counselling session vs 6 sessions Study: Appleby L Outcome Expt Expt Control Control Absolute effect Time point n mean (sd) n mean (sd) size (95% CI) [-7.34,8.54] (15.00) (11.40) 142 Postnatal depresssion A systematic review of published scientific literature to 1999

15 Figure 7.1 Summary of systematic review Systematic review of peer-reviewed treatment and prevention studies 143

16 Table 7.1 Characteristics of included studies Method Participants Interventions Appleby, 1997 Randomised controlled trial. Allocation by way of computergenerated random numbers. All women received some form of treatment as it was considered unethical to have a no treatment group. Participants blinded to drug allocation as were the counselling session psychologist and the supervising psychiatrist. Analysis was not performed on intention to treat basis. Women found by screening in an urban health district to be depressed at 6 8 weeks postpartum. Women who scored 10 on the EPDS were interviewed using the revised CIS. Those scoring 12 on the EPDS (the threshold for significant psychiatric morbidity and who satisfied RDC for major or minor depressive disorder) were invited to participate in the treatment trial. Women were excluded if there was a history of chronic (> 2yrs) or resistant depression, current drug or alcohol misuse, severe illness requiring hospital admission. Women who were breastfeeding were also excluded. 2,978 women were eligible for screening, 2,395 (80%) agreed to complete EPDS, 503 (21%) scored 10 on EPDS of whom 406 (81%) agreed to further assessment. 188(9.7% of initial sample) Confirmed cases of depression were identified of whom 87 (3.6% of initial sample) agreed to participate in the drug treatment trial. Eligible women were allocated to 1 of 4 treatment groups: 1. fluoxetine plus 1 counselling session. 2. fluoxetine plus 6 counselling sessions. 3. Placebo plus 1 counselling session 4. Placebo plus 6 counselling sessions. Fluoxetine is a serotonin specific reuptake inhibitor, a class of drugs that is anxiolytic and non-sedating. The counselling sessions were based on CBT and designed to be delivered by non-specialists in mental health, e.g. health visitors. Sessions were structured to offer reassurance. 144 Postnatal depresssion A systematic review of published scientific literature to 1999

17 Outcomes Notes Psychiatric morbidity after 1, 4, and 12 weeks, measured as mean scores and 95% confidence limits on the revised CIS, the EPDS and HRSD. The aim of the study was to determine the optimal treatment for non-psychotic depression in childbearing women. The hypotheses were: 6 counselling sessions would be more effective than 1 fluoxetine would be more effective than placebo, and after 1 counselling session the combination of fluoxetine and additional counselling would be equally effective. The authors found that in this group of women studied there was a benefit to women who received fluoxetine and a benefit to women who received CBT but, beyond an initial counselling session the benefit for women receiving both fluoxetine and counselling is less clear. It may be an individual woman s choice as to which mode of treatment she feels is most helpful. The study lacked the power to show any clear benefit that may have been detected. To show a difference of 4 in the mean scores between the 4 groups with a {sd} of 8.4, there was only a 24.7% power for 1 endpoint and 16% power for 2 endpoints. continued Systematic review of peer-reviewed treatment and prevention studies 145

18 Method Participants Interventions Midmer, Wilson & Cummings, 1995 The aim of the study was to Women assessed as being at measure the influence of a low risk for pregnancy prenatal intervention on the complications, who had already outcomes of postpartum paid to attend antenatal anxiety. Randomised controlled parenting classes at the study trial. Women randomly hospital and who were allocated to either routine available, with their partner, for antenatal parenting classes or to a 2 nd trimester intervention. routine antenatal classes plus 2 Data was available for 81 out of extra information sessions participants in the couples who fitted the study intervention group who criteria were contacted either by completed the 1 st questionnaire. phone or mail-out. 70 couples 55 of 58 control group agreed to participate. Analysis participants completed the was performed on an intention initial questionnaire. to treat basis. Control group Attendance at routine antenatal parenting classes. Intervention group Attendance at routine antenatal parenting classes plus attendance at 2 extra sessions, the contents of which were based on previous assessment of the educational needs of postnatal couples and included role-play and valuesclarification exercises. More couples were randomised to the intervention group to allow group sizes that would facilitate better group dynamics. Stamp, Williams & Crowther, 1995 Randomised controlled trial. After consenting, women were randomly allocated to 1 of 2 groups by a telephone call from the antenatal clinic to a researcher who opened the next in a series of sequentially numbered envelopes prepared in advance by a researcher independent of study involvement. The woman was informed of her allocation prior to leaving the clinic. It was calculated that a sample size of 140 would have an 80% chance of detecting a reduction of postnatal depression from 37% to 15 % at the 5% level of statistical significance. Assessors were not blind to study allocation. Women attending a public antenatal clinic. No privately insured patients attended the clinic and were therefore excluded. 249 women consented to complete a modified screening questionnaire (Leverton scale) to identify women vulnerable to postnatal depression. 144 screened as vulnerable. 73 were randomised to the intervention group and 71 to the control group. Following unavoidable exclusions, 71 women in the intervention group and 68 in the control group completed the trial. All women received the usual antenatal care offered by the hospital. In addition the intervention group were asked to attend, at 32 weeks and 36 weeks, 2 special antenatal classes designed to provide non-directive, practical and supportive sessions with an emphasis on the emotional and practical expectation of life changes precipitated by the arrival of a baby. Focus was on access to information, preparation and support, the development and extension of women s existing networks and goal setting abilities. Partners were encouraged to attend. 146 Postnatal depresssion A systematic review of published scientific literature to 1999

19 Outcomes Notes Marital adjustment and postnatal adjustment were measured by 3 scales, the Spielberger STAI and Spanier Dyadic Adjustment Scale. These were repeated in the postnatal period at 6 weeks and 6 months. In addition a postnatal evaluation using a modified version of O Hara s Postpartum Adjustment Questionnaire (PPAQ) was given at 6 weeks and 6 months. The STAI is a standardised 40-item self-report instrument consisting of a set of statements about anxiety and self-evaluation. Score range 20 80, the higher the score the higher the rate of anxiety. The DAS is a 32-item self-report scale including a dyadic consensus, satisfaction and affectational expression. Range 1 151, the higher the score the greater the marital adjustment. The PPAQ is a 61-item self-report measure developed to assess social role adjustment in childbearing women. Range , a low score indicating a better overall postnatal adjustment. The trial hypothesis was that women who attended 2 specific antenatal groups and 1 postnatal group would have a reduced frequency of postnatal depression by 59% from 37% to 15% at 6 weeks, 12 weeks and 6 months postpartum compared to a control group of women also vulnerable for postnatal depression. Outcome was measured by the use of the EPDS at 6 weeks, 12 weeks and 6 months postpartum. continued Systematic review of peer-reviewed treatment and prevention studies 147

20 Method Participants Interventions Oakley et al., 1990 Randomised controlled trial. Central coordinating centre contacted by telephone for randomisation schedule, stratified by centre. Ethics committee approval obtained from each hospital. Sample size calculation present describing 420 women being required for an 80% chance of detecting a difference of 150g in mean birthweight between groups. A total of 509 women recruited, 255 to the intervention group and 254 to the control group. Recruitment drawn from 4 hospital populations. Women were eligible to enter the trial if they had at least one normally formed infant weighing < 2,500g following spontaneous onset of labour, were less than 24 weeks gestation with a singleton pregnancy, were fluent in English and had been assessed as socially disadvantaged. Midwifery home visiting social support programme designed to improve birth outcomes for women who have previously had a low birth weight baby. The social support group received a minimum package of 3 home visits at 14, 20 and 24 weeks plus 2 phone calls and brief home visits between these times. There was 24-hour access to contacting a midwife. Semistructured interview schedules were used to maintain consistency of information. Any other information was kept to a minimum. No clinical care was provided. Wickberg & Hwang, 1996 Randomised controlled trial. A consecutive sample of Swedishspeaking women attending one of 17 child health clinics in the area surrounding Goteborg, Sweden were asked to complete an EPDS questionnaire at 2 and 3 months postpartum. Those who scored 12 were asked to participate in a further interview at which time they were assessed with the MADRS and diagnosed according to DSM-III-R for major depression. Those scoring a MADRS of 10 were invited to participate in the trial. The study nurses were given counselling training and supervised on a regular basis. A psychologist blinded to the women s study allocation performed the MADRS. The mean scores for depression were similar for each group (19.6 in the intervention group and 17.1 in the control group). 57 women eligible. 41 women agreed to participate and were randomly allocated to the intervention or control group. Characteristics of the two study groups were similar with respect to age, education level, marital status, type of delivery, previous episodes of depression and major depression at the time of the 1 st interview. Control group received usual routine care, not consisting of any check-ups, but with the possibility of attending the clinic whenever needed. Intervention group received usual routine care plus 6 weekly, 1-hour counselling sessions with a nurse at a predetermined time either in the woman s home or at the child health clinic. One week after the completion of the study period all participating women were assessed with the MADRS. 148 Postnatal depresssion A systematic review of published scientific literature to 1999

21 Outcomes Notes Baseline information was obtained on 507 women (2 lost to followup). At 6 weeks, 94% return rate for postal questionnaires 243(96%) in the intervention group and 234(92%) in control group. Pregnancy outcomes were obtained from the woman s case notes. The 6-week postnatal self-report questionnaire was not a standardised or replicable measure. Women in the intervention group had fewer admissions, were more likely to have a spontaneous vaginal delivery, lower rate of epidural use and were less likely to have an infant that was admitted to the neonatal intensive care unit. Intervention mothers had better subjective ratings of psychological adjustment in that they felt they were in control, had more help from their partners and did not report feelings of being low or depressed as often as the mothers in the control group. Although these findings were not based on standardised measures, they do provide some guidance. 12 (80%) of the women allocated to the intervention group diagnosed with major depression at the commencement of the trial, showed no evidence of having a major depression at the end of the 6 counselling sessions. In the control group, 4 (25%) of the 16 women showed no evidence of a major depression at the corresponding time point. Authors concluded that counselling by child health nurses, who have received training and regular supervision, is helpful in managing postnatal depression. continued Systematic review of peer-reviewed treatment and prevention studies 149

22 Method Wolman et al., 1993 Randomised controlled trial. Randomly ordered cards in sealed, opaque envelopes. Women were recruited only in the mornings to accommodate labour supporters who were unable to stay after dark. Participants Total of 189 nulliparous women with no significant obstetric problems who had < 6cm cervical dilatation and who did not have a supportive companion. 92 were randomised to the intervention group and 97 to the control group. 150 Postnatal depresssion A systematic review of published scientific literature to 1999

23 Interventions Outcomes Notes Intervention group women were assigned a lay supporter who stayed for the whole labour and birth (64) or labour only (24). Within 24 hours of delivery a structured questionnaire was administered by a clinical psychologist relating to perception of labour and pain experienced in labour and on day 1. Coopersmith Self-esteem Inventory, STAI, and a non-standard measure of depression, Pitt Depression inventory. Significant differences were found at 6 weeks between intervention and control groups for feeling competent during labour, self-esteem, anxiety and depression scores. However, as there was no follow-up of postnatal progress and as the depression measure used has no norms, recommended thresholds or indications of severity, the results are difficult to interpret in terms of how it may assist the prevention of postnatal depression. Systematic review of peer-reviewed treatment and prevention studies 151

24 Excluded studies Beck et al., 1985 Cullinan, 1991 Dalton, 1971 Fleming et al., 1992 Kissane & Ball, 1988 Leverton & Elliott, 1988 Marks et al., 1996 Meager & Milgrom, 1996 Reason for exclusion Not analysed on intention to treat i.e. those who did not complete the treatment were omitted. Study had only a 22% power to detect a difference of 6 with an (sd) of 11 at l2 months follow-up. Only 7% power to detect improvement from 70% improved (0 9) in CBT group to 85% in cognitive therapy plus amitriptyline group. Poor methodology. No data supplied to substantiate reported outcomes. No demographic information, no control group or standardised measure of depression used other than EPDS. The aim of this study was to determine whether postnatal depression was caused by a woman s difficulty in adjusting to the marked difference between hormone levels in late pregnancy and the early puerperium. No formal assessment of women s hormone levels appear to have been undertaken to form a baseline for whether change has occurred. No standardised measures were used. Reliability between ratings was not assessed and no differentiation was made between the 3 postpartum mood disorders that may occur during the study data collection phase. No randomisation. The way in which the groups were formed/initiated makes comparison difficult and the data needed to be viewed as three separate samples. Review of l4 patients attending a mother-baby unit in a general psychiatric hospital over two-year period. Insufficient data. Lack of description of follow-up. Readmission was the only outcome measure mentioned. Conference paper. Little informative data presented. Study methodology has never been published in peer reviewed medical or psychological literature, so difficult to assess quality and reproducibility of information. Non-concurrent controls. Some recruits were already in a trial of postpartum psychosis, having had a previous episode of severe mental illness. Preliminary results only given as trial was still in progress. Use of chi-square for analysis was not appropriate. Not analysed on intention to treat Confounders such as concurrent medication, time since onset of depression and small group sizes made it very difficult to find validation of assumptions. Insufficient power to detect the desired difference rates. Should be treated and discussed as pilot study only. 152 Postnatal depresssion A systematic review of published scientific literature to 1999