Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care

Overview

Patients in the IPCM group (n = 112) received intensive psychotherapy and case management, and those in the CAU group (n = 102) received care as usual, including behavioral health referrals and/or brief onsite interventions.

Full Title of Study: “Effects of Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care: A Randomized Control Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 1, 2018

Detailed Description

IPCM patients received routine services from both a psychotherapist and separate mental health case manager for one year; duration of each appointment was 45 minutes – 1 hour; frequency of appointments was weekly or every other week, dependent on participant availability. A face-to-face professional interpreter was utilized unless the CVT provider was a native Karen speaker.

Participants in the control group received care as usual, without CVT involvement other than administration of the outcome measures. Once randomized, CAU patients could be referred to a full range of outpatient and community-based behavioral health services by their primary care physician.

Interventions

  • Behavioral: Intensive Psychotherapy and case management for refugee trauma
    • CVT’s approach emphasized active interdisciplinary coordination and a relational focus anchored in cultural humilityX to address survivors’ priorities, empower survivors as the primary architects of their healing, and work alongside each survivor to co-construct meaning and behavioral change.

Arms, Groups and Cohorts

  • Experimental: Intensive Psychotherapy Case Management
    • Treatment group received Intensive Psychotherapy and Case Management (IPCM) delivered by psychotherapists and social worker with expertise in refugee trauma and mental health.
  • Active Comparator: Treatment as Usual (TAU)
    • Treatment as Usual group received ongoing care from their primary care providers without the involvement of CVT (except for the collection of outcomes). TAU patients could be referred to a full range of outpatient and community-based behavioral health services by their primary care physician.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Depression over time
    • Time Frame: Collected at baseline, 3, 6, and 12 months
    • Hopkins Symptom Trauma Checklist (HSCL-25) consists of 25 items with 15 items evaluating depression symptoms with response scale scores ranging from 1 (not at all) to 4 (extremely) indicating the frequency and severity of symptoms. Low scores indicate low symptoms while higher scores indicate greater symptoms of depression.
  • Change in Anxiety over time
    • Time Frame: Collected at baseline, 3, 6, and 12 months
    • Hopkins Symptom Trauma Checklist (HSCL-25) consists of 25 items with 10 items assessing anxiety symptoms with response scale scores ranging from 1 (not at all) to 4 (extremely) indicating the frequency and severity of symptoms. Low scores indicate low symptoms while higher scores indicate greater symptoms of anxiety.
  • Change in PTSD over time
    • Time Frame: Collected at baseline, 3, 6, and 12 months
    • Posttraumatic Stress Disorder (PDS-5) consists of 21 items evaluating symptoms of posttraumatic stress with response scale scores ranging from 1 (not at all) to 4 (extremely) indicating the frequency and severity of symptoms. Low scores indicate low symptoms while higher scores indicate greater symptoms of PTSD.
  • Change in Pain over time
    • Time Frame: Collected at baseline, 3, 6, and 12 months
    • Pain Complaints Scale consists of 5 items assessing general pain symptoms with response scale scores ranging from 1 (not at all) to 4 (extremely) indicating the frequency and severity of symptoms. Low scores indicate low symptoms while higher scores indicate greater symptoms of pain.
  • Change in Safety/Basic Needs over time
    • Time Frame: Collected at baseline, 3, 6, and 12 months
    • Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). Safety/basic needs measures frequency and quality of basic needs met in housing, clothing, food, and transportation. Subscale scores are calculated as total scores.
  • Change in Immigration Stability over time
    • Time Frame: Collected at baseline, 3, 6, and 12 months
    • Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). Immigration stability measures legal status and stability for work, healthcare and residence in the country and progress towards citizenship. Subscale scores are calculated as total scores.
  • Change in Employment over time
    • Time Frame: Collected at baseline, 3, 6, and 12 months
    • Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). Employment subscale consists of 5 items measuring motivation for, and frequency and quality of employment. Subscale scores are calculated as total scores.
  • Change in Social Support over time
    • Time Frame: Collected at baseline, 3, 6, and 12 months
    • Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). The social support subscale consists of 5 items measuring frequency and quality of social connections in family and friends. Subscale scores are calculated as total scores.
  • Change in Cultural Adjustment over time
    • Time Frame: Collected at baseline, 3, 6, and 12 months
    • Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (lower functioning) to 4 (higher functioning). Cultural Adjustment consists of 5 items measuring adaptation to new cultural and geographic community. Subscale scores are calculated as total scores.
  • Change in Community Engagement over time
    • Time Frame: Collected at baseline, 3, 6, and 12 months
    • Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). Community engagement consists of 6 items measuring participation in civic, political, social and educational activities in the geographic community. Subscale scores are calculated as total scores.

Participating in This Clinical Trial

Inclusion Criteria

  • Eligibility criteria included Major Depression diagnosis by SCID interview, Karen refugee, ages 18-65.

Exclusion Criteria

Exclusion criteria were current participation in individual psychotherapy or case management, psychosis, or substance use problems on the CAGE-AID.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Center for Victims of Torture, United States
  • Collaborator
    • University of Minnesota
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maria Vukovich, Research Associate – The Center for Victims of Torture, United States

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