A Comparison of Cognitive and Dynamic Therapy for Depress... | NCT01207271

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

NCT01207271

Sponsor

University of Pennsylvania

Status

Completed

Last Update Posted

May 2, 2017Actual

Enrollment

237Actual

Phase

Not Applicable

Conditions

Major Depressive Disorder

Interventions

Cognitive Therapy
Supportive-Expressive Psychodynamic Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Dec 9, 2014Actual

Completion Date

Dec 9, 2014Actual

First Submitted Date

Sep 21, 2010

First Submission Date that Met QC Criteria

Sep 21, 2010

First Posted Date

Sep 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2017

Last Update Posted Date

May 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

237Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cognitive Therapy	Experimental		Behavioral: Cognitive Therapy
Dynamic Therapy	Experimental		Behavioral: Supportive-Expressive Psychodynamic Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Therapy	Behavioral	16 sessions of cognitive therapy administered weekly by a community mental health therapist	Cognitive Therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary Beth Gibbons, Ph.D.	University of Pennsylvania	Principal Investigator
Paul Crits-Christoph, Ph.D.	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27487573	Derived	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.
25566391	Derived	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.

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

ID	Term
D015928	Cognitive Behavioral Therapy
D064889	Psychotherapy, Psychodynamic

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities