- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02134678
Assessing Change in Short Term Therapy for Depression
April 30, 2015 updated by: Kari M Eddington, University of North Carolina, Greensboro
Assessing Change in Short Term Therapy for Depression Using ESM
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Greensboro, North Carolina, United States, 27412
- UNC Greensboro
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: self-system therapy
self-system therapy for depression
|
|
Active Comparator: cognitive therapy
cognitive therapy for depression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Depressive symptoms - Beck Depression Inventory-II
Time Frame: post-treatment and 6 month follow up
|
post-treatment and 6 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Anxiety - Beck Anxiety Inventory
Time Frame: post-treatment and 6 month follow up
|
post-treatment and 6 month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
May 5, 2014
First Submitted That Met QC Criteria
May 7, 2014
First Posted (Estimate)
May 9, 2014
Study Record Updates
Last Update Posted (Estimate)
May 1, 2015
Last Update Submitted That Met QC Criteria
April 30, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21MH090414-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
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-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
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Henry M. Jackson Foundation for the Advancement...Congressionally Directed Medical Research ProgramsCompletedSuicide, AttemptedUnited States
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Henry M. Jackson Foundation for the Advancement...University of Pennsylvania; University of Michigan; Duke University; US Department... and other collaboratorsUnknownSuicide, Attempted | Suicidal Ideation ActiveUnited States
-
University of BergenCompleted
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University of MalayaCompletedCognitive Impairment | Mild Traumatic Brain InjuryMalaysia
-
Laval UniversityUniversity of California, BerkeleyCompleted
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University of WashingtonNational Multiple Sclerosis SocietyCompletedMultiple SclerosisUnited States
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