NCT01207271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2014

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

4.1 years

First QC Date

September 21, 2010

Last Update Submit

April 28, 2017

Conditions

Major Depressive Disorder

Keywords

depressioncommunity mental healthtreatmentpsychotherapymediators

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Depression (HAM-D)

    6 months

Secondary Outcomes (8)

  • BASIS-24

    6 months

  • Beck Depression Inventory - II (BDI-II)

    6 months

  • Medical Outcomes Study 36-Item Short Form (SF-36)

    6 months

  • Quality of Life Inventory (QOLI)

    6 months

  • Ways of Responding (WOR)

    2 months

  • +3 more secondary outcomes

Study Arms (2)

Cognitive Therapy

EXPERIMENTAL
Behavioral: Cognitive Therapy

Dynamic Therapy

EXPERIMENTAL
Behavioral: Supportive-Expressive Psychodynamic Therapy

Interventions

Cognitive TherapyBEHAVIORAL

16 sessions of cognitive therapy administered weekly by a community mental health therapist

Also known as: Cognitive Behavioral Therapy, CBT
Cognitive Therapy
Supportive-Expressive Psychodynamic TherapyBEHAVIORAL

16 sessions of supportive-expressive psychodynamic therapy administered weekly by a community mental health therapist

Also known as: Psychodynamic Psychotherapy, Short Term Dynamic Therapy
Dynamic Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of major depressive disorder
  • Able to read at the 4th grade level or higher
  • Willingness to be randomized and participate in research

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

    PMID: 27487573DERIVED

  • 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.

    PMID: 25566391DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Cognitive Behavioral TherapyPsychotherapy, Psychodynamic

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mary Beth Gibbons, Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Paul Crits-Christoph, Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 22, 2010

Study Start

November 1, 2010

Primary Completion

December 9, 2014

Study Completion

December 9, 2014

Last Updated

May 2, 2017

Record last verified: 2017-04

Locations

US(1)