A Comparison of Cognitive and Dynamic Therapy for Depression in Community Settings
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Therapy
Supportive-Expressive Psychodynamic Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, community mental health, treatment, psychotherapy, mediators
Eligibility Criteria
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cognitive Therapy
Dynamic Therapy
Arm Description
Outcomes
Primary Outcome Measures
Hamilton Rating Scale for Depression (HAM-D)
Secondary Outcome Measures
BASIS-24
Beck Depression Inventory - II (BDI-II)
Medical Outcomes Study 36-Item Short Form (SF-36)
Measure of general functionality
Quality of Life Inventory (QOLI)
Ways of Responding (WOR)
Dysfunctional Attitudes Scale (DAS)
Psychological Distance Scaling Task (PDST)
Self-Understanding of Interpersonal Patterns Scale-Revised (SUIP-R)
Full Information
NCT ID
NCT01207271
First Posted
September 21, 2010
Last Updated
April 28, 2017
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01207271
Brief Title
A Comparison of Cognitive and Dynamic Therapy for Depression in Community Settings
Official Title
A Comparison of Cognitive and Dynamic Therapy for MDD in Community Settings
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 9, 2014 (Actual)
Study Completion Date
December 9, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, community mental health, treatment, psychotherapy, mediators
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
237 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Therapy
Arm Type
Experimental
Arm Title
Dynamic Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy
Other Intervention Name(s)
Cognitive Behavioral Therapy, CBT
Intervention Description
16 sessions of cognitive therapy administered weekly by a community mental health therapist
Intervention Type
Behavioral
Intervention Name(s)
Supportive-Expressive Psychodynamic Therapy
Other Intervention Name(s)
Psychodynamic Psychotherapy, Short Term Dynamic Therapy
Intervention Description
16 sessions of supportive-expressive psychodynamic therapy administered weekly by a community mental health therapist
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAM-D)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
BASIS-24
Time Frame
6 months
Title
Beck Depression Inventory - II (BDI-II)
Time Frame
6 months
Title
Medical Outcomes Study 36-Item Short Form (SF-36)
Description
Measure of general functionality
Time Frame
6 months
Title
Quality of Life Inventory (QOLI)
Time Frame
6 months
Title
Ways of Responding (WOR)
Time Frame
2 months
Title
Dysfunctional Attitudes Scale (DAS)
Time Frame
2 months
Title
Psychological Distance Scaling Task (PDST)
Time Frame
2 months
Title
Self-Understanding of Interpersonal Patterns Scale-Revised (SUIP-R)
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Beth Gibbons, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Crits-Christoph, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27487573
Citation
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.
Results Reference
derived
PubMed Identifier
25566391
Citation
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.
Results Reference
derived
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A Comparison of Cognitive and Dynamic Therapy for Depression in Community Settings
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