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Clinical Trials/NCT01207271
NCT01207271
Completed
Not Applicable

A Comparison of Cognitive and Dynamic Therapy for MDD in Community Settings

University of Pennsylvania1 site in 1 country237 target enrollmentNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
University of Pennsylvania
Enrollment
237
Locations
1
Primary Endpoint
Hamilton Rating Scale for Depression (HAM-D)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The goal of this study is to compare supportive-expressive therapy, a type of psychodynamic psychotherapy, with cognitive therapy for the treatment of depression in community mental health consumers.

Hypothesized mediators of treatment will also be examined.

Detailed Description

The goal of this study is to conduct a randomized, comparative, non-inferiority clinical trial that tests the hypothesis that a widely used form of manualized dynamic psychotherapy (supportive-expressive psychodynamic therapy) is not inferior to cognitive therapy when implemented in community mental health settings for the treatment of major depressive disorder (MDD). The specific aims are (1) to conduct a randomized non-inferiority trial to compare supportive-expressive psychodynamic therapy and cognitive therapy for patients with MDD and (2) to assess the comparative effectiveness of supportive-expressive psychodynamic therapy and cognitive therapy on secondary measures of symptoms, patient functioning, and quality of life. Patient mediators of outcome will also be examined through an additional grant awarded to Paul Crits-Christoph, Ph.D. This grant was funded by the National Institutes of Mental Health - RO1MH092363-01. This grant is entitled:"The mechanisms of cognitive and dynamic therapy in community settings." Recruitment will occur solely through community mental health clinics in and around Philadelphia.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
December 9, 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of major depressive disorder
  • Able to read at the 4th grade level or higher
  • Willingness to be randomized and participate in research

Exclusion Criteria

  • Current or past diagnosis of schizophrenia, seizure disorder, bipolar disorder, psychotic features, or clinically significant organic pathology
  • Significant suicidal risk/ideation requiring immediate referral for more intensive treatment, or specific gesture in the last 6 months
  • Current substance abuse or dependence requiring immediate referral to substance abuse program
  • Acute medical problem requiring immediate inpatient treatment
  • Need for referral to a partial hospitalization program

Outcomes

Primary Outcomes

Hamilton Rating Scale for Depression (HAM-D)

Time Frame: 6 months

Secondary Outcomes

  • Beck Depression Inventory - II (BDI-II)(6 months)
  • Quality of Life Inventory (QOLI)(6 months)
  • Dysfunctional Attitudes Scale (DAS)(2 months)
  • Ways of Responding (WOR)(2 months)
  • BASIS-24(6 months)
  • Medical Outcomes Study 36-Item Short Form (SF-36)(6 months)
  • Psychological Distance Scaling Task (PDST)(2 months)
  • Self-Understanding of Interpersonal Patterns Scale-Revised (SUIP-R)(2 months)

Study Sites (1)

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