NCT01542372

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

May 17, 2017

Completed
Last Updated

May 17, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

February 21, 2012

Results QC Date

February 20, 2017

Last Update Submit

April 10, 2017

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

PTSDCognitive behavioral therapy (CBT)Medication augmentationTreatment-resistant PTSDCambodian refugeesCulturally sensitive treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in the HSCL Anxiety Scale at 12 Weeks in Step II

    Baseline and 12 weeks

  • Change in the HSCL Depression Scale at 12 Weeks in Step II

    Baseline and 12 weeks

  • Change in the SCL Anger Severity at 12 Weeks in Step II

    Baseline and 12 weeks

  • Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II

    Baseline and 12 weeks

  • Change in the SF-12 at 12 Weeks in Step II

    Baseline and 12 weeks

Study Arms (2)

Medication augmentation

ACTIVE COMPARATOR

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

Drug: Medication augmentation

CBT augmentation

ACTIVE COMPARATOR

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

Behavioral: CBT

Interventions

Medication augmentationDRUG
Also known as: Prazosin is the first choice agent in this Arm
Medication augmentation
CBTBEHAVIORAL
Also known as: Cognitive-Behavioral Therapy
CBT augmentation

Eligibility Criteria

Age43 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PTSD;
  • PCL great or equal to 44;
  • Survivor of the Cambodian genocide;
  • At least 7 years old at the time of the Cambodian genocide

You may not qualify if:

  • Pregnant;
  • Active suicidality;
  • Mental retardation;
  • Organic mental disorder;
  • Bipolar disorder;
  • Alcohol dependence;
  • Marijuana dependence;
  • Unable to give conformed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Owing to lack of recruitment sites the study was ended early. In addition, many more patients than anticipated had no PTSD after Step I and hence could not be randomized to participate in Step II. This greatly impacted on flow.

Results Point of Contact

Title
Dr. Devon Hinton
Organization
Massachusetts
DHINTON1@mgh.harvard.edu
617-620-4522

Study Officials

  • Devon E. Hinton, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

February 21, 2012

First Posted

March 2, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 17, 2017

Results First Posted

May 17, 2017

Record last verified: 2017-04

Locations

US(1)