Assessing Change in Short Term Therapy for Depression

Study Overview
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Brief Summary
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This study will compare mechanisms of action in two forms of brief psychotherapy for major depressive disorder in adults. A treatment that targets deficits in motivation in depression is expected to show greater improvements in motivation and pursuit of personal goals compared to a second treatment that targets irrational thoughts that are typical in depression.

Detailed Description
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Outcome studies have shown that several forms of psychotherapy are effective for depression, but questions about how, why, and when these treatments work remain. The proposed study answers the call for innovative research designs that allow for more intensive, individualized data collection that can address complex questions about the dynamic nature of treatment-related change. In this R21 application, we propose a proof-of-concept study using an innovative application of experience sampling methodology (ESM) that combines the idiographic advantages of single-subject research with the statistical advantages associated with larger samples and multilevel analyses. ESM involves sampling aspects of behavior occurring in the participant's everyday environment, thereby enhancing ecological validity and reducing retrospective bias. Thirtyfour adults with primary major depressive disorder will be randomly assigned to 16 weeks of either selfsystem therapy (SST), a new short-term, empirically-supported psychotherapy for depression that targets deficits in incentive motivation and goal pursuit, or treatment-as-usual (TAU). Participants will complete a battery of individual difference and diagnostic measures at pretreatment. One week of intensive ESM will be collected at both pre- and post-treatment, during which participants will be signaled at random times during each day to answer questions about current functioning in several domains (e.g., affect, cognition, and goal pursuit) delivered via a phone-based interactive voice response (IVR) system. Throughout the 16 weeks of treatment, participants will complete similar IVR assessments on two randomly-selected days per week. The proposed study will test three main hypotheses. (1) Patients in SST will show greater increases in engagement with promotion goals and activities as well as greater increases in goal-related daily experiences of positive affect over the course of treatment compared to patients in TAU. (2) Patients in SST will show greater decreases in engagement with prevention goals and activities as well as greater decreases in goal- related daily experiences of negative affect over the course of treatment compared to patients in TAU. (3) Within the SST condition, a history of failure to pursue or achieve promotion goals and individual differences in chronic regulatory orientation (i.e., strength of orientation toward promotion and prevention goals) will moderate the effects of SST on changes in depressive symptoms and on daily experiences of promotion goal engagement. The proposed research will have a significant impact on an important public health problem and will expand our knowledge of how psychotherapy for depression works. The data to be obtained from this study will provide a sound empirical and theoretical framework for largerscale programmatic research on the nature of treatment-induced change processes in patients with depression.

Official Title
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Assessing Change in Short Term Therapy for Depression Using ESM

Conditions
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Depression

Intervention / Treatment
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* Behavioral: self-system therapy
* Behavioral: cognitive therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary diagnoses of major depressive disorder or dysthymia age 18-60 Exclusion Criteria: bipolar substance abuse acute suicidality antisocial or borderline personality disorder cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: self-system therapy<br>self-system therapy for depression | Behavioral: self-system therapy<br> <br> |
| Active Comparator: cognitive therapy<br>cognitive therapy for depression | Behavioral: cognitive therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depressive symptoms - Beck Depression Inventory-II |  | post-treatment and 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety - Beck Anxiety Inventory |  | post-treatment and 6 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-system therapy, cognitive therapy, depression, psychotherapy, mechanisms of action