Treatments for Depression Study

Purpose
The purpose of this study is to compare the efficacy of a short-term dynamic therapy, medication (SSRI/SNRI) + clinical management, and pill placebo + clinical management.

Overview

• Brief phone screen
• Diagnostic/medical evaluation
• 16 weeks of active treatment (weekly sessions)
• 4 month continuation of treatment (monthly sessions)
• 2 years of follow-up

Criteria for participation in the study:

• Age between 18 and 70 years of age
• Diagnosis of major depressive disorder (MDD) lasting at least 2 weeks
• No history of bipolar disorder (manic depression)

STEP 1: Phone Screen
Initially, a brief phone screen will be conducted assessing the symptoms of depression, associated problems such as eating, sleeping, drinking, or relational problems, any previous or current treatments, other mental health problems, and pertinent physical/health concerns. If treatment through the study seems appropriate, an appointment will be scheduled, typically within 2 days.

STEP 2: Intake Evaluation
Prior to entering the study, all potential participants undergo an extensive diagnostic, medical, and physical evaluation. The complete evaluation lasts 4-5 hours and is scheduled over two days, one week apart. The evaluation involves a comprehensive interview in which the symptoms, severity, and length of the depression as well as other potential mental health disorders such as anxiety problems, sleeping or eating difficulties, drug or alcohol use, relationship conflicts, and psychosis are assessed. Each potential participant will also meet with a psychiatrist to review the person's medical and health history. Any health or medical problems identified as potentially conflicting with treatment (particularly use of the assigned medication) will be discussed with the person and appropriate referrals for assessment or treatment made.

STEP 3: Treatment
Following completion of the Intake, the participant will be randomly assigned to one of three treatment conditions. Participants will receive:

1. 16 weeks of antidepressant medication (SSRI/SNRI) + case management followed by 4 months of continued treatment, OR
2. 16 weeks of Supportive-Expressive psychotherapy (during the first 4 weeks sessions are twice a week) followed by 4 months of monthly sessions, OR
3. 16 weeks of pill placebo control + case management followed by 4 months of treatment with an antidepressant medication (SSRI/SNRI).

Active Phase
An appointment for the first treatment session will be made within one week of assignment. Treatment continues weekly for 16 weeks. Each medical case management session will last approximately 20 minutes and will include a review of the patient's symptoms and side-effects, answer questions, and offer support and encouragement. Each therapy session will last approximately 50 minutes and will include a discussion of the major problems with which the patient is dealing. Participants in the medication/pill placebo conditions will remain blind as to which pill is being given.

Continuation Phase
Following completion of the first 16 weeks of treatment, the blind regarding drug treatment will be broken. Participants assigned to the active drug treatment condition will continue taking antidepressant medication (SSRI/SNRI) and have monthly case management visits for 16 weeks. Participants assigned to the pill placebo condition will begin treatment with an antidepressant medication and have weekly case management visits for 16 weeks. Participants assigned to psychotherapy will continue monthly sessions with the treating therapist.

STEP 4: Follow-Up
All patients, regardless of treatment assigned, will be followed for two years after completion of the active and continuation phases of the study. Follow-up assessments will be scheduled at 3-month intervals and will last approximately 1-2 hours. Follow-up appointments will include a brief diagnostic interview and completion of self-report questionnaires.

Principal Investigator:  Jacques Barber, PhD, ABPP (NIMH funded)

< back to Depression Studies page