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

Primary Purpose

Posttraumatic Stress Disorder (PTSD)

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Medication augmentation
CBT
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder (PTSD) focused on measuring PTSD, Cognitive behavioral therapy (CBT), Medication augmentation, Treatment-resistant PTSD, Cambodian refugees, Culturally sensitive treatment

Eligibility Criteria

43 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Medication augmentation

CBT augmentation

Arm Description

In one arm, the patients will be given a medication augmentation for SSRI/SSRN-resistant PTSD

In this arm, patients will receive CBT to treat SSRI/SSRN-resistant PTSD.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
February 21, 2012
Last Updated
April 10, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01542372
Brief Title
Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD
Official Title
Two Stepped Care Models for PTSD Among Cambodian Refugees With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Inadequate flow of patients
Study Start Date
April 2012 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD)
Keywords
PTSD, Cognitive behavioral therapy (CBT), Medication augmentation, Treatment-resistant PTSD, Cambodian refugees, Culturally sensitive treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication augmentation
Arm Type
Active Comparator
Arm Description
In one arm, the patients will be given a medication augmentation for SSRI/SSRN-resistant PTSD
Arm Title
CBT augmentation
Arm Type
Active Comparator
Arm Description
In this arm, patients will receive CBT to treat SSRI/SSRN-resistant PTSD.
Intervention Type
Drug
Intervention Name(s)
Medication augmentation
Other Intervention Name(s)
Prazosin is the first choice agent in this Arm
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
Cognitive-Behavioral Therapy
Primary Outcome Measure Information:
Title
Change in the PTSD Checklist (PCL) at 12 Weeks in Step II
Description
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.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in the HSCL Anxiety Scale at 12 Weeks in Step II
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in the HSCL Depression Scale at 12 Weeks in Step II
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in the SCL Anger Severity at 12 Weeks in Step II
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in the SF-12 at 12 Weeks in Step II
Description
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.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devon E. Hinton, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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