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

This study has been terminated.
(Inadequate flow of patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542372
First Posted: March 2, 2012
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Devon E. Hinton, Massachusetts General Hospital
  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 Phase
Posttraumatic Stress Disorder (PTSD) Drug: Medication augmentation Behavioral: CBT Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 Devon E. Hinton, Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in the PTSD Checklist (PCL) at 12 Weeks in Step II [ Time Frame: Baseline and 12 weeks ]
    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 [ Time Frame: Baseline and 12 weeks ]
    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 [ Time Frame: Baseline and 12 weeks ]
    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 [ Time Frame: Baseline and 12 weeks ]
    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 [ Time Frame: Baseline and 12 weeks ]
    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 [ Time Frame: Baseline and 12 weeks ]
    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.


Enrollment: 114
Actual Study Start Date: April 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Medication augmentation
In one arm, the patients will be given a medication augmentation for SSRI/SSRN-resistant PTSD
Drug: Medication augmentation
Other Name: 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 Name: Cognitive-Behavioral Therapy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   43 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542372


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Devon E. Hinton, MD, PhD Massachusetts General Hospital
  More Information

Responsible Party: Devon E. Hinton, Associate Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01542372     History of Changes
Other Study ID Numbers: MH094312
First Submitted: February 21, 2012
First Posted: March 2, 2012
Results First Submitted: February 20, 2017
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders