NCT02134678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started May 2011

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 1, 2015

Status Verified

April 1, 2015

Enrollment Period

3 years

First QC Date

May 5, 2014

Last Update Submit

April 30, 2015

Conditions

Depression

Keywords

self-system therapycognitive therapydepressionpsychotherapymechanisms of action

Outcome Measures

Primary Outcomes (1)

  • Change in Depressive symptoms - Beck Depression Inventory-II

    post-treatment and 6 month follow up

Secondary Outcomes (1)

  • Change in Anxiety - Beck Anxiety Inventory

    post-treatment and 6 month follow up

Study Arms (2)

self-system therapy

EXPERIMENTAL

self-system therapy for depression

Behavioral: self-system therapy

cognitive therapy

ACTIVE COMPARATOR

cognitive therapy for depression

Behavioral: cognitive therapy

Interventions

self-system therapyBEHAVIORAL
self-system therapy
cognitive therapyBEHAVIORAL
cognitive therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • primary diagnoses of major depressive disorder or dysthymia
  • age 18-60

You may not qualify if:

  • bipolar
  • substance abuse
  • acute suicidality
  • antisocial or borderline personality disorder
  • cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Greensboro

Greensboro, North Carolina, 27412, United States

Location

Related Publications (1)

  • 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.

    PMID: 25867448DERIVED

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 9, 2014

Study Start

May 1, 2011

Primary Completion

May 1, 2014

Study Completion

November 1, 2014

Last Updated

May 1, 2015

Record last verified: 2015-04

Locations

US(1)