Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Group IPT for Depression + TAU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as Usual (TAU)<br>Standard prison mental health treatment instead of the research groups, including individual therapy, medication, etc. | |
| Experimental: Group Interpersonal Psychotherapy (IPT) for Depression + TAU<br>Participants will receive Group IPT for Depression + TAU. | Behavioral: Group IPT for Depression + TAU<br>* Interpersonal psychotherapy (IPT) will be administered in 20 group 90-minute sessions over 10 weeks and 4 individual sessions (before group starts, in the middle of the group, at the end of the group, and one month after the group ends). These sessions will focus on improving your relationships with others, building healthy relationships, setting goals, and increasing coping skills. Additionally, participants will receive standard prison mental health treatment, individual therapy, medication, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months |  | 3 Months from Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Suicidality at 3 Months | Suicidality as measured by the Beck Scale for Suicide Ideation. | 3 Months from Baseline | 
| Change from Baseline in In-Prison Functioning at 3 Months | In-prison functioning will be assessed by the number of correctional programs enrolled/completed and disciplinary/incident reports (measured by the Timeline Followback); aggression/victimization (measured by the Conflict Tactics Scale 2); social support (measured by the Multidimensional Scale of Perceived Social Support and the UCLA Loneliness Scale) | 3 Months from Baseline | 
| Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months |  | 6 Months from Baseline | 
| Change from Baseline in Suicidality at 6 Months | Suicidality as measured by the Beck Scale for Suicide Ideation. | 6 Months from Baseline | 
| Change from Baseline in In-Prison Functioning at 6 Months | In-prison functioning will be assessed by the number of correctional programs enrolled/completed and disciplinary/incident reports (measured by the Timeline Followback); aggression/victimization (measured by the Conflict Tactics Scale 2); social support (measured by the Multidimensional Scale of Perceived Social Support and the UCLA Loneliness Scale) | 6 Months from Baseline | 
| Cost-effectiveness | Cost-effectiveness based on costs of IPT and TAU, improvements in HRSD scores, LIFE scores, and cost-offsets, including medical costs, programs completed, fewer fights, fewer suicide attempts, and reduced length of incarceration due to more good time. | 6 months post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder (MDD), Suicidality, Incarcerated Populations, Prisons, Interpersonal Psychotherapy (IPT)