Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care

NCT03788408 | Unknown

• 1 other identifier: 1001
• Study Type: interventional
• Target: 214
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Delivery of Intensive Behavioral Services to Refugees in Primary Care

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Intensive Psychotherapy Case Management

EXPERIMENTAL

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

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Interventions

Intensive Psychotherapy and case management for refugee trauma BEHAVIORAL

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.

Intensive Psychotherapy Case Management; Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• The Center for Victims of Torture, United States: lead
• University of Minnesota: collaborator
• HealthEast Care System: collaborator

Related Publications (2)

• Vukovich M, Esala J, Beckman A, Northwood A, Vinson G, Letts J, Danner C. Cost Savings from Integrating Behavioral Health in Primary Care: A Pragmatic Randomized Control Trial with Karen Refugees. J Immigr Minor Health. 2025 Nov 2. doi: 10.1007/s10903-025-01806-7. Online ahead of print.

  PMID: 41176745 DERIVED

• Northwood AK, Vukovich MM, Beckman A, Walter JP, Josiah N, Hudak L, O'Donnell Burrows K, Letts JP, Danner CC. Intensive psychotherapy and case management for Karen refugees with major depression in primary care: a pragmatic randomized control trial. BMC Fam Pract. 2020 Jan 28;21(1):17. doi: 10.1186/s12875-020-1090-9.

  PMID: 31992234 DERIVED

MeSH Terms

Interventions

Case Management

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 27, 2018
• Study Start: May 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: July 1, 2020
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share