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Assessing Change in Short Term Therapy for Depression

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ClinicalTrials.gov Identifier: NCT02134678
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Kari M Eddington, University of North Carolina, Greensboro

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: self-system therapy Behavioral: cognitive therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessing Change in Short Term Therapy for Depression Using ESM
Study Start Date : May 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: self-system therapy
self-system therapy for depression
Behavioral: self-system therapy
Active Comparator: cognitive therapy
cognitive therapy for depression
Behavioral: cognitive therapy



Primary Outcome Measures :
  1. Change in Depressive symptoms - Beck Depression Inventory-II [ Time Frame: post-treatment and 6 month follow up ]

Secondary Outcome Measures :
  1. Change in Anxiety - Beck Anxiety Inventory [ Time Frame: post-treatment and 6 month follow up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134678


Locations
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United States, North Carolina
UNC Greensboro
Greensboro, North Carolina, United States, 27412
Sponsors and Collaborators
University of North Carolina, Greensboro
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kari M Eddington, Assistant Professor, University of North Carolina, Greensboro
ClinicalTrials.gov Identifier: NCT02134678    
Other Study ID Numbers: 1R21MH090414-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: April 2015
Keywords provided by Kari M Eddington, University of North Carolina, Greensboro:
self-system therapy
cognitive therapy
depression
psychotherapy
mechanisms of action
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders