STAR*D: Sequenced Treatment Alternatives to Relieve Depression Data Collection Procedures for Cognitive Therapists

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1 LEVEL 2 ENTRY When a patient is randomized to receive Cognitive Therapy, the CRC will give the therapist the following information and materials: On the day of randomization: Patient name and contact information Intake information, and a brief summary of the patient s course in the study Randomization arm either CT alone (CT Switch) or CT with Celexa (CT Augment) CRC contact information to be used as backup in patient emergencies when the therapist might not be available Within 2 days of randomization, appropriate data collection forms pre-printed with the relevant patient, therapist, and CRC STAR*D Study IDs Therapists should photocopy the data collection forms for each session as needed. As forms are completed, therapists should log the date and form information on the CT Invoice Form. If photocopying is not possible, additional forms may be printed from the STAR*D website at by taking the following steps: 1) Select Document Sharing Data Collection Forms Cognitive Therapy 2) Select the appropriate packet: Full or Partial, English or Spanish 3) Forms will be displayed in Acrobat Reader (to download free copy of Acrobat Reader, click the yellow icon at the bottom of the web page) 4) Enter patient and therapist STAR*D IDs (optional): click the appropriate fields on the first page of the form and type in ID numbers. The numbers will be automatically placed on every page of the form. 5) Click the print icon at the top of the screen to print packet Three to seven days after randomization, the Data Coordinating Center will to the therapist a calendar listing each day for the next 14 weeks. The calendar will identify: expected full assessment dates (for CT Switch, to include CRF and QIDS assessments) expected therapy session dates the session and/or week number to be used for appointments on days other than expected dates Revised 09/05/2003 Page 1 of 7

2 DATA TO BE COLLECTED BY STUDY THERAPISTS The amount and frequency of data collection will depend on whether the patient is randomized to CT Augment or to CT Switch. Patients in CT Augment will be seen for therapy sessions only: 8 semi-weekly sessions for four weeks, and then 8 weekly sessions for eight more weeks. If a patient reaches remission earlier than week 10 (see Outcomes below), the therapist may allow the frequency of visits to lengthen to biweekly until week 12. The CRC will provide a Partial Packet of forms, since only the Therapist Checklist (TC form) will be completed at these sessions. In addition to completing the TC, therapists are to audiotape the sessions. Patients in CT Switch will be seen for the same therapy sessions as those in CT Augment, and will have TC forms and audiotapes submitted for each session. At the end of weeks 2, 4, 6, 9, and 12, additional assessments will be completed, and will be documented on the CRF-CT and the two QIDS forms (QS Self-Report and QC Clinician Interview). These forms will be included in the Full Packet of forms provided by the CRC. The randomization date is considered to be the start of treatment. All weeks and sessions will be counted from this point. The calendar provided by the Data Coordinating Center should be used as a guideline when scheduling appointments and is intended to help to determine the appropriate week or session designation for data collection forms. Sequential session numbers: Each TC form/therapy session should be numbered sequentially. For example, if a patient skips the third session, the TC form completed at the next session will be numbered 3 rather than 4. This change from earlier stated protocols is intended to simplify data management for the therapists. Therapists may be flexible with scheduling therapy sessions in order to complete between sessions within the 12-week time period. If sessions are missed, the therapist may schedule make-up appointments in order to catch up with the expected number of sessions. Revised 09/05/2003 Page 2 of 7

3 Protocol week designations: Forms documenting the additional assessments (CRF, QS, and QC) will be identified by week number (i.e. 0, 2, 4, 6, 9, and 12). The assessments are to be made on the dates indicated on the 14-week calendar, but may be made anywhere within six days on either side of that date. If an assessment cannot be made within that 13-day window, a Protocol Deviation (PD) form must be submitted documenting the missed assessment. The PD form may be printed from the STAR*D website, found under Document Sharing Data Collection Forms Event-Driven Forms. SUBMITTING FORMS TO THE DATA COORDINATING CENTER CRCs will take care of faxing all forms to the Data Coordinating Center and sending all audiotapes of therapy sessions to the Cognitive Therapy Director (Dr. Ed Friedman). It is the therapist s responsibility to review all forms to ensure they are complete and correct before giving them to the CRC. This includes reviewing the QIDS Self-Report before the patient leaves the office, in case some questions were misunderstood or inadvertently skipped. On a weekly basis, therapists should photocopy all forms collected over the past 7 days, and give (or send) the originals to the CRC responsible for the patient s case. Therapists should have been logging all forms on the CT Invoice as the forms were completed, so the invoice should be ready for copying as well. The original invoice goes with the original data collection forms to the CRC, and the copies stay with the therapist. Along with the forms, all audiotapes recorded during the past 7 days should be given to the CRCs for shipping to Dr. Friedman. Revised 09/05/2003 Page 3 of 7

4 PATIENT OUTCOMES Patients in the CT Augment arm will have been seeing their STAR*D pharmacotherapist and the CRC as well as seeing the CT throughout the 12-week treatment course. The pharmacotherapist and CRC, in consultation with the cognitive therapist, will determine outcome for these patients. Patients in the CT Switch arm have been solely in the care of the cognitive therapist. Therefore, the determination of outcome is the responsibility of the therapist. It is important that the CRC is informed the same day that the outcome is determined, either in writing or verbally, so that there will not be any delay in beginning the next step. There are three possible outcomes of the course of cognitive therapy: remission, non-response and partial response. 1. Remission Patients who achieve a QIDS-C score of 5 or lower will be considered to have had a satisfactory response to cognitive therapy, and to be in remission. Patients who reach remission will enter the one-year follow-up phase of the study after completing 12 weeks of CT. For purposes of continuity of care, remitted patients in follow-up can see their STAR*D therapists for 4 booster sessions over the remainder of the year. No data are to be collected during these sessions. 2. Partial responders Patients who achieve a QIDS-C score between 6 and 8 (inclusive) are considered to be partial responders. These patients have two options: 1) continue in the randomized portion of the study to try other medications, in which case the CRC should randomize them into Level 2A 2) move into the one-year follow-up phase of the study. Partial responders who choose this option will be eligible to continue receiving cognitive therapy according to the following schedule: 4 weekly sessions of cognitive therapy for one month 4 biweekly sessions of cognitive therapy over the next two months 9 monthly sessions of cognitive therapy for the remainder of the 12-month course During these additional sessions in follow-up, therapists are encouraged to follow the STAR*D treatment protocol. However, no data are to be submitted to the Data Coordinating Center or to Dr. Friedman during follow-up. Revised 09/05/2003 Page 4 of 7

5 3. Non-responders Patients whose lowest QIDS score is 9 or above after 12 weeks are considered to be non-responders. These patients are to be randomized to receive new medications in Level 2A. Patients who show signs of improvement at their week 12 visit may be kept in treatment for an additional two weeks to determine whether they achieve partial response or remission. During those two weeks, two therapy sessions may be given, and at the end of the two weeks, another full packet of assessments should be administered in order to determine the final outcome. It is expected that patients will remain in treatment for at least 12 weeks, but if, at any time during the treatment course, a patient is not improving and is unwilling to continue with cognitive therapy, the patient may ask to be randomized into Level 2A at that time. NONCOMPLIANCE WITH COGNITIVE THERAPY A Cognitive Therapy patient who experiences a period of more than 14 days between therapy sessions is considered to be noncompliant with Cognitive Therapy as conducted in STAR*D, and must leave the Cognitive Therapy treatment level. The RC Director will consult with the Cognitive Therapist and the CRC to determine whether the patient may continue in the study by entering Level 2A or must be exited from the study completely. COMPENSATION FOR UNINSURED PATIENTS IN FOLLOW-UP Therapists can receive compensation for treating patients in the follow-up phase of the study if the patient has no insurance coverage. Payment can be requested by submitting a Follow-Up Visit Payment Form for each uninsured session. The Follow-Up Visit Payment may be printed from the STAR*D website, found under Document Sharing Data Collection Forms Event-Driven Forms. Therapists are responsible for completing this form and faxing it to the Data Coordinating Center in order to initiate the payment process. Revised 09/05/2003 Page 5 of 7

6 SERIOUS ADVERSE EVENTS A Serious Adverse Event (SAE) is defined as any event that Results in death Is life-threatening Is a failed suicide attempt Requires inpatient hospitalization or prolongs existing hospitalization Results in a persistent or severe disability/incapacity Is medically significant, or Results in a congenital anomaly/birth defect. Furthermore, important medical events that may not result in death, be life threatening, or require hospitalization may still be considered a serious adverse experience when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above. If at any time it is questionable whether an adverse event qualifies as an SAE or not, contact the STAR*D Clinical Manager: Diane Stegman Phone: Diane.Stegman@UTSouthwestern.edu Any time an SAE is noted, an SAE form is to be completed and faxed immediately to the Data Coordinating Center at The SAE form may be printed from the STAR*D website, found under Document Sharing Data Collection Forms Event-Driven Forms. In addition, the CRC is to be notified immediately. EMERGENCIES If the therapist will not be available due to an emergency or planned travel, it is the responsibility of the therapist to inform the CRC and the patient. The therapist should provide the patient with information on how to contact the CRC in the event of an emergency. Revised 09/05/2003 Page 6 of 7

7 SAMPLE Cognitive Therapy Appointment Calendar: Patient ID TES WEEK PACKET PROTOCOL DAY DATE DUE WEEK SESSION Friday 08/23/02* 0 1 Saturday 08/24/ Sunday 08/25/ Monday 08/26/02 PARTIAL 0 1 Tuesday 08/27/ Wednesday 08/28/ Thursday 08/29/02 PARTIAL 0 2 Friday 08/30/ Saturday 08/31/ Sunday 09/01/ Monday 09/02/02 PARTIAL 2 3 Tuesday 09/03/ Wednesday 09/04/ Thursday 09/05/02 FULL 2 4 Friday 09/06/ Saturday 09/07/ Sunday 09/08/ Monday 09/09/02 PARTIAL 2 5 Tuesday 09/10/ Wednesday 09/11/ Thursday 09/12/02 PARTIAL 2 6 Friday 09/13/ Saturday 09/14/ Sunday 09/15/ Monday 09/16/02 PARTIAL 4 7 Tuesday 09/17/ Wednesday 09/18/ Thursday 09/19/02 FULL 4 8 Friday 09/20/ Saturday 09/21/ Sunday 09/22/ Monday 09/23/ Tuesday 09/24/ Wednesday 09/25/ Thursday 09/26/02 PARTIAL 4 9 Friday 09/27/ Saturday 09/28/ Sunday 09/29/ Monday 09/30/ Tuesday 10/01/ Wednesday 10/02/ Thursday 10/03/02 FULL 6 10 * First date on calendar is date of randomization into Level 2 WEEK PACKET PROTOCOL DAY DATE DUE WEEK SESSION Friday 10/04/ Saturday 10/05/ Sunday 10/06/ Monday 10/07/ Tuesday 10/08/ Wednesday 10/09/ Thursday 10/10/02 PARTIAL 6 11 Friday 10/11/ Saturday 10/12/ Sunday 10/13/ Monday 10/14/ Tuesday 10/15/ Wednesday 10/16/ Thursday 10/17/02 PARTIAL 6 12 Friday 10/18/ Saturday 10/19/ Sunday 10/20/ Monday 10/21/ Tuesday 10/22/ Wednesday 10/23/ Thursday 10/24/02 FULL 9 13 Friday 10/25/ Saturday 10/26/ Sunday 10/27/ Monday 10/28/ Tuesday 10/29/ Wednesday 10/30/ Thursday 10/31/02 PARTIAL 9 14 Friday 11/01/ Saturday 11/02/ Sunday 11/03/ Monday 11/04/ Tuesday 11/05/ Wednesday 11/06/ Thursday 11/07/02 PARTIAL 9 15 Friday 11/08/ Saturday 11/09/ Sunday 11/10/ Monday 11/11/ Tuesday 11/12/ Wednesday 11/13/ Thursday 11/14/02 FULL Friday 11/15/ Saturday 11/16/ Sunday 11/17/ Monday 11/18/ Tuesday 11/19/ Wednesday 11/20/ Be sure to contact CRC as soon as patient is ready to leave Level 2 Revised 05/01/2003 Page 7 of 7