Clinical trial NCT01685294: Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression
Official title: Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder (MDD)
Suicidality
Incarcerated Populations
Prisons
Interpersonal Psychotherapy (IPT)
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-09-14
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effects of a first-line treatment for major depressive disorder (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.

Detailed description: The purpose of this 3-year randomized trial is to promote uptake of evidence-based treatment in criminal justice settings by conducting a fully-powered randomized effectiveness study that collects pilot implementation data, including cost-effectiveness data. Group IPT will be compared to treatment as usual (TAU) in a sample of 90 male and 90 female prisoners with MDD from 4 institutions, allowing us to explore gender effects.

Eligibility criteria: Inclusion Criteria:

* Meet all DSM-IV criteria for primary (non-substance induced) major depressive disorder
* Expectation of at least 6 months of incarceration at baseline interview
* Incarcerated for at least 4 weeks

Exclusion Criteria:

* Lifetime:

  * Bipolar disorder
  * Psychotic disorder
* Are imminently suicidal
* Cannot understand English well enough to understand the consent form or assessment instruments when read aloud

Primary outcomes:
measure: Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months
timeFrame: 3 Months from Baseline
Secondary outcomes:
measure: Change from Baseline in Suicidality at 3 Months
timeFrame: 3 Months from Baseline
measure: Change from Baseline in In-Prison Functioning at 3 Months
timeFrame: 3 Months from Baseline
measure: Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months
timeFrame: 6 Months from Baseline
measure: Change from Baseline in Suicidality at 6 Months
timeFrame: 6 Months from Baseline
measure: Change from Baseline in In-Prison Functioning at 6 Months
timeFrame: 6 Months from Baseline
measure: Cost-effectiveness
timeFrame: 6 months post-baseline
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Massachusetts Correctional Institute - Old Colony Correctional Center
state: Massachusetts
city: Framingham
country: United States
facility: Massachusetts Correctional Institution - Framingham
state: Massachusetts
city: Framingham
country: United States
facility: South Middlesex Correctional Center
state: Massachusetts
city: Norfolk
country: United States
facility: Massachusetts Correctional Institution - Norfolk
state: Massachusetts
city: Cranston
country: United States
facility: Adult Correctional Institution - Men's & Women's Medium & Minimum Security Facilities
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jennifer E. Johnson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Felton JW, Hailemariam M, Richie F, Reddy MK, Edukere S, Zlotnick C, Johnson JE. Preliminary efficacy and mediators of interpersonal psychotherapy for reducing posttraumatic stress symptoms in an incarcerated population. Psychother Res. 2020 Feb;30(2):239-250. doi: 10.1080/10503307.2019.1587192. Epub 2019 Mar 11.
citation: Johnson JE, Stout RL, Miller TR, Zlotnick C, Cerbo LA, Andrade JT, Nargiso J, Bonner J, Wiltsey-Stirman S. Randomized cost-effectiveness trial of group interpersonal psychotherapy (IPT) for prisoners with major depression. J Consult Clin Psychol. 2019 Apr;87(4):392-406. doi: 10.1037/ccp0000379. Epub 2019 Feb 4.