Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD
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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 |
- 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
- 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 |
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| Contact: Devon E Hinton, MD, PhD | 617-620-4522 | devon_hinton@hms.harvard.edu |
| 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 | |
| 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 May 19, 2013