Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD

This study is not yet open for participant recruitment.
Verified February 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Devon E. Hinton, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01542372
First received: February 21, 2012
Last updated: February 25, 2012
Last verified: February 2012
  Purpose

This project aims to investigate the efficacy of two models to treat Posttraumatic Stress Disorder (PTSD) for Cambodian refugees in primary care. The first step in both models is giving a medication, which is a serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SSRN), with paroxetine being the first-line agent. For those patients who still have PTSD, the second step is either another medication or a culturally sensitive cognitive behavioral therapy (CBT). The investigators hypothesize that patients will improve in both models, but more so in the the CBT model.


Condition Intervention
Posttraumatic Stress Disorder (PTSD)
Biological: Prazosin as first-line agent
Behavioral: Cognitive Behavioral Therapy for PTSD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Two Stepped Care Models for PTSD Among Cambodian Refugees With PTSD

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in the PTSD Checklist (PCL) at 12 weeks in Step II [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    A measure of PTSD severity


Secondary Outcome Measures:
  • Change in the HSCL Anxiety Scale at 12 weeks in Step II [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    A measure of anxiety severity

  • Change in the HSCL Depression Scale at 12 weeks in Step II [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    A measure of depression severity

  • SCL Anger Severity [ Time Frame: Change in the SCL Anger Scale at 12 weeks in Step II ] [ Designated as safety issue: No ]
    A measure of anger severity

  • Change in the Cambodian Culturally Sensitive Complaint Profile at 12 weeks in Step II [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    A measure of somatic symptoms and cultural syndromes commonly found among distressed Cambodian refugees

  • Change in the SF-12 at 12 weeks in Step II [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    A measure of self-perceived functioning


Estimated Enrollment: 243
Study Start Date: April 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Medication augmentation (prazosin)
In one arm, the patients will be given a medication augmentation for SSRI/SSRN-resistant PTSD, with the preferred first-line agent being prazosin.
Biological: Prazosin as first-line agent
Prazosin .5 to 2 mg
Other Name: Minipress
Active Comparator: Cognitive Behavior Therapy (CBT)
In this arm, patients will receive CBT to treat SSRI/SSRN-resistant PTSD.
Behavioral: Cognitive Behavioral Therapy for PTSD
This is a culturally sensitive CBT for the treatment of PTSD
Other Name: CBT

Detailed Description:

This project aims to investigate the efficacy of two models to treat PTSD for Cambodian refugees in primary care. The first step in both models is giving a medication (an SSRI/SSRN, e.g., paroxetine). For those who still have PTSD, the second step is either adding another medication (e.g., prazosin) or providing culturally sensitive cognitive behavioral therapy (CBT). We hypothesize that patients will improve in both models, but more so in the the CBT model. The primary outcome measure is PTSD severity as assessed by the PTSD Checklist (PCL). Eligibility requirements include having PTSD and having been old enough to remember the Khmer Rouge period.

  Eligibility

Ages Eligible for Study:   43 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PTSD;
  • PCL great or equal to 44;
  • Survivor of the Cambodian genocide;
  • At least 7 years old at the time of the Cambodian genocide

Exclusion Criteria:

  • Pregnant;
  • Active suicidality;
  • Mental retardation;
  • Organic mental disorder;
  • Bipolar disorder;
  • Alcohol dependence;
  • Marijuana dependence;
  • Unable to give conformed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542372

Contacts
Contact: Devon E Hinton, MD, PhD 617-620-4522 devon_hinton@hms.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Devon E. Hinton, MD, PhD         
Principal Investigator: Devon E. Hinton, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Devon E. Hinton, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Devon E. Hinton, Associate Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01542372     History of Changes
Other Study ID Numbers: MH094312
Study First Received: February 21, 2012
Last Updated: February 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
PTSD
Cognitive behavioral therapy (CBT)
Medication augmentation
Treatment-resistant PTSD
Cambodian refugees
Culturally sensitive treatment

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Prazosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014