A Phase 3 interventional study of Group IPT for Depression + TAU in Major Depressive Disorder, sponsored by Brown University. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-13.
Sponsored by Brown University · Phase 3, Interventional, and Treatment
This study will examine the effects of a first-line treatment for major depressive disorder (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.
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.
8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 181 is above the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →Brown University is the lead sponsor of 282 studies on the registry; 42 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lifetime:
Standard prison mental health treatment instead of the research groups, including individual therapy, medication, etc.
Participants will receive Group IPT for Depression + TAU.
Behavioral: Group IPT for Depression + TAU
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.
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months
Time frame: 3 Months from Baseline
Change from Baseline in Suicidality at 3 Months
Suicidality as measured by the Beck Scale for Suicide Ideation.
Time frame: 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)
Time frame: 3 Months from Baseline
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months
Time frame: 6 Months from Baseline
Change from Baseline in Suicidality at 6 Months
Suicidality as measured by the Beck Scale for Suicide Ideation.
Time frame: 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)
Time frame: 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."
Time frame: 6 months post-baseline
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Brown University