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

Two Stepped Care Models for PTSD Among Cambodian Refugees With PTSD

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.

Study Overview

• Status: Terminated
• Conditions: Posttraumatic Stress Disorder (PTSD)
• Intervention / Treatment: Behavioral: CBT; Drug: Medication augmentation

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medication augmentation; In one arm, the patients will be given a medication augmentation for SSRI/SSRN-resistant PTSD	Drug: Medication augmentation; Other Names: Prazosin is the first choice agent in this Arm
Active Comparator: CBT augmentation; In this arm, patients will receive CBT to treat SSRI/SSRN-resistant PTSD.	Behavioral: CBT; Other Names: Cognitive-Behavioral Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the PTSD Checklist (PCL) at 12 Weeks in Step II	A measure of PTSD severity, which is the PTSD Checklist. Total score range is 17 to 85, with a higher score indicating greater psychopathology. Change scores were calculated.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the HSCL Anxiety Scale at 12 Weeks in Step II	A measure of anxiety severity, which is the HSCL Anxiety Scale. Each item is rated on a 1-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 1 and a maximum of 4. Change scores were calculated.	Baseline and 12 weeks
Change in the HSCL Depression Scale at 12 Weeks in Step II	A measure of depression severity, which is the HSCL Depression Scale. Each item is rated on a 1-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 1 and a maximum of 4. Change scores were calculated.	Baseline and 12 weeks
Change in the SCL Anger Severity at 12 Weeks in Step II	A measure of anger severity, which is the SCL Anger Scale. Each item is rated on a 0-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 0 and a maximum of 4. Change scores were calculated.	Baseline and 12 weeks
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. Each item is rated on a 0-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 0 and a maximum of 4. Change scores were calculated.	Baseline and 12 weeks
Change in the SF-12 at 12 Weeks in Step II	A measure of severity of self-perceived functioning. Total score ranges from 0 to 100, with a higher score indicating better self-perceived functioning. Change scores were calculated.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Devon E. Hinton, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: February 25, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: PTSD; Cognitive behavioral therapy (CBT); Medication augmentation; Treatment-resistant PTSD; Cambodian refugees; Culturally sensitive treatment
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Prazosin
• Other Study ID Numbers: MH094312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes