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

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Cognitive Therapy; Behavioral: Supportive-Expressive Psychodynamic 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.

• Study Type: Interventional
• Enrollment (Actual): 237
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hamilton Rating Scale for Depression (HAM-D)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BASIS-24		6 months
Beck Depression Inventory - II (BDI-II)		6 months
Medical Outcomes Study 36-Item Short Form (SF-36)	Measure of general functionality	6 months
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Mary Beth Gibbons, Ph.D., University of Pennsylvania; Principal Investigator: Paul Crits-Christoph, Ph.D., University of Pennsylvania

Publications and helpful links

General Publications

• Connolly Gibbons MB, Gallop R, Thompson D, Luther D, Crits-Christoph K, Jacobs J, Yin S, Crits-Christoph P. Comparative Effectiveness of Cognitive Therapy and Dynamic Psychotherapy for Major Depressive Disorder in a Community Mental Health Setting: A Randomized Clinical Noninferiority Trial. JAMA Psychiatry. 2016 Sep 1;73(9):904-11. doi: 10.1001/jamapsychiatry.2016.1720. Erratum In: JAMA Psychiatry. 2017 Jan 1;74(1):107.
• Connolly Gibbons MB, Mack R, Lee J, Gallop R, Thompson D, Burock D, Crits-Christoph P. Comparative effectiveness of cognitive and dynamic therapies for major depressive disorder in a community mental health setting: study protocol for a randomized non-inferiority trial. BMC Psychol. 2014 Nov 11;2(1):47. doi: 10.1186/s40359-014-0047-y. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 9, 2014
• Study Completion (Actual): December 9, 2014

Study Registration Dates

• First Submitted: September 21, 2010
• First Submitted That Met QC Criteria: September 21, 2010
• First Posted (Estimate): September 22, 2010

Study Record Updates

• Last Update Posted (Actual): May 2, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: treatment; depression; community mental health; psychotherapy; mediators
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: R01HS018440 (U.S. AHRQ Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No