Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care

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

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.

Study Overview

• Status: Unknown
• Conditions: Delivery of Intensive Behavioral Services to Refugees in Primary Care
• Intervention / Treatment: Behavioral: Intensive Psychotherapy and case management for refugee trauma

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.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Center for Victims of Torture, United States
• Collaborators: University of Minnesota; HealthEast Care System

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): February 1, 2018
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 26, 2018
• First Posted (Actual): December 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1001 (Registro Nacional Estudios Clinicos (RNEC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No