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

Posttraumatic Stress Disorder (PTSD) Clinical Trial

Official title:

Two Stepped Care Models for PTSD Among Cambodian Refugees With PTSD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01542372
• Other study ID #: MH094312
• Status: Terminated
• Phase: N/A
• First received: February 21, 2012
• Last updated: February 9, 2017
• Start date: April 2012
• Est. completion date: March 2014

Study information

• Verified date: February 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 114
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 43 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Biological:
• Prazosin as first-line agent
Prazosin .5 to 2 mg

Behavioral:
• Cognitive Behavioral Therapy for PTSD
This is a culturally sensitive CBT for the treatment of PTSD

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the PTSD Checklist (PCL) at 12 weeks in Step II	A measure of PTSD severity	Baseline and 12 weeks
Secondary	Change in the HSCL Anxiety Scale at 12 weeks in Step II	A measure of anxiety severity	Baseline and 12 weeks
Secondary	Change in the HSCL Depression Scale at 12 weeks in Step II	A measure of depression severity	Baseline and 12 weeks
Secondary	SCL Anger Severity	A measure of anger severity	Change in the SCL Anger Scale at 12 weeks in Step II
Secondary	Change in the Cambodian Culturally Sensitive Complaint Profile at 12 weeks in Step II	A measure of somatic symptoms and cultural syndromes commonly found among distressed Cambodian refugees	Baseline and 12 weeks
Secondary	Change in the SF-12 at 12 weeks in Step II	A measure of self-perceived functioning	Baseline and 12 weeks