A Comparison of Cognitive and Dynamic Therapy for Depression in Community Settings
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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 |
- Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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:
|
| 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:
|
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 |
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| Contact: Tessa Mooney, B.A. | 215-349-5222 | mooneyt@mail.med.upenn.edu |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Tessa Mooney, B.A. 215-349-5222 mooneyt@mail.med.upenn.edu | |
| Principal Investigator: Mary Beth Gibbons, Ph.D. | |
| Principal Investigator: Paul Crits-Christoph, Ph.D. | |
| 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: | June 26, 2012 |
| 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 May 19, 2013