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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207271
• Other study ID #: R01HS018440
• Status: Completed
• Phase: N/A
• First received: September 21, 2010
• Last updated: April 28, 2017
• Start date: November 2010
• Est. completion date: December 9, 2014

Study information

• Verified date: April 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: December 9, 2014
• Est. primary completion date: December 9, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Cognitive Therapy
16 sessions of cognitive therapy administered weekly by a community mental health therapist
• Supportive-Expressive Psychodynamic Therapy
16 sessions of supportive-expressive psychodynamic therapy administered weekly by a community mental health therapist

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression (HAM-D)		6 months
Secondary	BASIS-24		6 months
Secondary	Beck Depression Inventory - II (BDI-II)		6 months
Secondary	Medical Outcomes Study 36-Item Short Form (SF-36)	Measure of general functionality	6 months
Secondary	Quality of Life Inventory (QOLI)		6 months
Secondary	Ways of Responding (WOR)		2 months
Secondary	Dysfunctional Attitudes Scale (DAS)		2 months
Secondary	Psychological Distance Scaling Task (PDST)		2 months
Secondary	Self-Understanding of Interpersonal Patterns Scale-Revised (SUIP-R)		2 months