Clinical trial NCT01207271: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
community mental health
treatment
psychotherapy
mediators
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: 6 months
Secondary outcomes:
measure: BASIS-24
timeFrame: 6 months
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: 6 months
measure: Medical Outcomes Study 36-Item Short Form (SF-36)
timeFrame: 6 months
measure: Quality of Life Inventory (QOLI)
timeFrame: 6 months
measure: Ways of Responding (WOR)
timeFrame: 2 months
measure: Dysfunctional Attitudes Scale (DAS)
timeFrame: 2 months
measure: Psychological Distance Scaling Task (PDST)
timeFrame: 2 months
measure: Self-Understanding of Interpersonal Patterns Scale-Revised (SUIP-R)
timeFrame: 2 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mary Beth Gibbons, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Paul Crits-Christoph, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.