Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatments cognitive therapy, supportive-expressive psychodynamic therapy
Phase phase 3
Sponsor University of Pennsylvania
Start date November 2010
End date September 2016
Trial size 230 participants
Trial identifier NCT01207271, R01HS018440

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cognitive therapy Cognitive Behavioral Therapy
16 sessions of cognitive therapy administered weekly by a community mental health therapist
(Experimental)
supportive-expressive psychodynamic therapy Psychodynamic Psychotherapy
16 sessions of supportive-expressive psychodynamic therapy administered weekly by a community mental health therapist

Primary Outcomes

Measure
Hamilton Rating Scale for Depression (HAM-D)
time frame: 6 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Comparison of Cognitive and Dynamic Therapy for MDD in Community Settings
Principal investigator Mary Beth Gibbons, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.