Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care: A Randomized Control Trial

Conditions
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Delivery of Intensive Behavioral Services to Refugees in Primary Care

Intervention / Treatment
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* Behavioral: Intensive Psychotherapy and case management for refugee trauma


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Intensive Psychotherapy Case Management<br>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<br>* 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.<br>|
| Active Comparator: Treatment as Usual (TAU)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression over time | 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. | Collected at baseline, 3, 6, and 12 months | 
| Change in Anxiety over time | 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. | Collected at baseline, 3, 6, and 12 months | 
| Change in PTSD over time | 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. | Collected at baseline, 3, 6, and 12 months | 
| Change in Pain over time | 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. | Collected at baseline, 3, 6, and 12 months | 
| Change in Safety/Basic Needs over time | 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. | Collected at baseline, 3, 6, and 12 months | 
| Change in Immigration Stability over time | 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. | Collected at baseline, 3, 6, and 12 months | 
| Change in Employment over time | 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. | Collected at baseline, 3, 6, and 12 months | 
| Change in Social Support over time | 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. | Collected at baseline, 3, 6, and 12 months | 
| Change in Cultural Adjustment over time | 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. | Collected at baseline, 3, 6, and 12 months | 
| Change in Community Engagement over time | 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. | Collected at baseline, 3, 6, and 12 months |