Clinical trial NCT03788408: Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care
Official title: Effects of Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delivery of Intensive Behavioral Services to Refugees in Primary Care
Lead sponsor: The Center for Victims of Torture, United States
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: HealthEast Care System
First posted: 2018-12-27
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Depression over time
timeFrame: Collected at baseline, 3, 6, and 12 months
measure: Change in Anxiety over time
timeFrame: Collected at baseline, 3, 6, and 12 months
measure: Change in PTSD over time
timeFrame: Collected at baseline, 3, 6, and 12 months
measure: Change in Pain over time
timeFrame: Collected at baseline, 3, 6, and 12 months
measure: Change in Safety/Basic Needs over time
timeFrame: Collected at baseline, 3, 6, and 12 months
measure: Change in Immigration Stability over time
timeFrame: Collected at baseline, 3, 6, and 12 months
measure: Change in Employment over time
timeFrame: Collected at baseline, 3, 6, and 12 months
measure: Change in Social Support over time
timeFrame: Collected at baseline, 3, 6, and 12 months
measure: Change in Cultural Adjustment over time
timeFrame: Collected at baseline, 3, 6, and 12 months
measure: Change in Community Engagement over time
timeFrame: Collected at baseline, 3, 6, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.