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Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care

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ClinicalTrials.gov Identifier: NCT03788408
Recruitment Status : Active, not recruiting
First Posted : December 27, 2018
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
University of Minnesota
HealthEast Care System
Information provided by (Responsible Party):
Maria Vukovich, The Center for Victims of Torture, United States

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Delivery of Intensive Behavioral Services to Refugees in Primary Care Behavioral: Intensive Psychotherapy and case management for refugee trauma Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care: A Randomized Control Trial
Actual Study Start Date : May 1, 2013
Actual Primary Completion Date : February 1, 2018
Estimated Study Completion Date : July 1, 2020

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.


  10. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Maria Vukovich, Research Associate, The Center for Victims of Torture, United States
ClinicalTrials.gov Identifier: NCT03788408     History of Changes
Other Study ID Numbers: 1001
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No