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Completed

NCT Number: NCT01685294

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

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

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Self-Injurious Behavior Suicidal Ideation Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Massachusetts Correctional Institute - Old Colony Correctional Center, Bridgewater, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group IPT for Depression + TAU

Behavioral

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.

Primary outcomes

  1. Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months

    Time frame: 3 Months from Baseline

Secondary outcomes

  1. Change from Baseline in Suicidality at 3 Months

    Time frame: 3 Months from Baseline

    Suicidality as measured by the Beck Scale for Suicide Ideation.

  2. Change from Baseline in In-Prison Functioning at 3 Months

    Time frame: 3 Months from Baseline

    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. Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months

    Time frame: 6 Months from Baseline

  4. Change from Baseline in Suicidality at 6 Months

    Time frame: 6 Months from Baseline

    Suicidality as measured by the Beck Scale for Suicide Ideation.

  5. Change from Baseline in In-Prison Functioning at 6 Months

    Time frame: 6 Months from Baseline

    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. Cost-effectiveness

    Time frame: 6 months post-baseline

    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."

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 14, 2012
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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