Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care

NCT ID: NCT03788408

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-01

Study Completion Date

2020-07-01

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.

Conditions

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Delivery of Intensive Behavioral Services to Refugees in Primary Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Intensive Psychotherapy and case management for refugee trauma

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Intensive Psychotherapy and case management for refugee trauma

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Eligibility criteria included Major Depression diagnosis by SCID interview, Karen refugee, ages 18-65.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role collaborator

HealthEast Care System

OTHER

Sponsor Role collaborator

The Center for Victims of Torture, United States

OTHER

Sponsor Role lead

Responsible Party

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Maria Vukovich

Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 31992234 (View on PubMed)

Other Identifiers

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1001

Identifier Type: -

Identifier Source: org_study_id

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