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Assessing Change in Short Term Therapy for Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
self-system therapy
cognitive therapy
Sponsored by
University of North Carolina, Greensboro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression focused on measuring self-system therapy, cognitive therapy, depression, psychotherapy, mechanisms of action

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNC Greensboro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

self-system therapy

cognitive therapy

Arm Description

self-system therapy for depression

cognitive therapy for depression

Outcomes

Primary Outcome Measures

Change in Depressive symptoms - Beck Depression Inventory-II

Secondary Outcome Measures

Change in Anxiety - Beck Anxiety Inventory

Full Information

First Posted
May 5, 2014
Last Updated
April 30, 2015
Sponsor
University of North Carolina, Greensboro
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1. Study Identification

Unique Protocol Identification Number
NCT02134678
Brief Title
Assessing Change in Short Term Therapy for Depression
Official Title
Assessing Change in Short Term Therapy for Depression Using ESM
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Greensboro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
self-system therapy, cognitive therapy, depression, psychotherapy, mechanisms of action

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
self-system therapy
Arm Type
Experimental
Arm Description
self-system therapy for depression
Arm Title
cognitive therapy
Arm Type
Active Comparator
Arm Description
cognitive therapy for depression
Intervention Type
Behavioral
Intervention Name(s)
self-system therapy
Intervention Type
Behavioral
Intervention Name(s)
cognitive therapy
Primary Outcome Measure Information:
Title
Change in Depressive symptoms - Beck Depression Inventory-II
Time Frame
post-treatment and 6 month follow up
Secondary Outcome Measure Information:
Title
Change in Anxiety - Beck Anxiety Inventory
Time Frame
post-treatment and 6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UNC Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27412
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25867448
Citation
Eddington KM, Silvia PJ, Foxworth TE, Hoet A, Kwapil TR. Motivational deficits differentially predict improvement in a randomized trial of self-system therapy for depression. J Consult Clin Psychol. 2015 Jun;83(3):602-616. doi: 10.1037/a0039058. Epub 2015 Apr 13.
Results Reference
derived

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Assessing Change in Short Term Therapy for Depression

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