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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Mary Beth Gibbons, Ph.D., University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01207271
First received: September 21, 2010
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Behavioral: Cognitive Therapy
Behavioral: Supportive-Expressive Psychodynamic Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Cognitive and Dynamic Therapy for MDD in Community Settings

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BASIS-24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Beck Depression Inventory - II (BDI-II) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Medical Outcomes Study 36-Item Short Form (SF-36) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measure of general functionality

  • Quality of Life Inventory (QOLI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Ways of Responding (WOR) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Dysfunctional Attitudes Scale (DAS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Psychological Distance Scaling Task (PDST) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Self-Understanding of Interpersonal Patterns Scale-Revised (SUIP-R) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: November 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Therapy Behavioral: Cognitive Therapy
16 sessions of cognitive therapy administered weekly by a community mental health therapist
Other Names:
  • Cognitive Behavioral Therapy
  • CBT
Experimental: Dynamic Therapy Behavioral: Supportive-Expressive Psychodynamic Therapy
16 sessions of supportive-expressive psychodynamic therapy administered weekly by a community mental health therapist
Other Names:
  • Psychodynamic Psychotherapy
  • Short Term Dynamic Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207271

Contacts
Contact: Jacqueline K Lee, B.A. 215-349-5222 jacquel@mail.med.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jacqueline K Lee, B.A.    215-349-5222    jacquel@mail.med.upenn.edu   
Principal Investigator: Mary Beth Gibbons, Ph.D.         
Principal Investigator: Paul Crits-Christoph, Ph.D.         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Mary Beth Gibbons, Ph.D. University of Pennsylvania
Principal Investigator: Paul Crits-Christoph, Ph.D. University of Pennsylvania
  More Information

No publications provided

Responsible Party: Mary Beth Gibbons, Ph.D., Associate Professor of Psychology in Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01207271     History of Changes
Other Study ID Numbers: R01HS018440
Study First Received: September 21, 2010
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pennsylvania:
depression
community mental health
treatment
psychotherapy
mediators

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 22, 2014