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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT01207271

Collaborator

(none)

237

Enrollment

Location

Arms

49.2

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Behavioral: Cognitive Therapy Behavioral: Supportive-Expressive Psychodynamic Therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

237 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Dec 9, 2014

Actual Study Completion Date :

Dec 9, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Hamilton Rating Scale for Depression (HAM-D) [6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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