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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care

NCT04937504

Posttraumatic Stress Disorder

COMPLETED NA

Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial

NCT01492348

Posttraumatic Stress Disorder (PTSD) Depression

COMPLETED NA

Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy

NCT00215163

Stress Disorders, Post-Traumatic

COMPLETED PHASE2/PHASE3

Stepped Care for Children After Trauma: Optimizing Treatment

NCT02537678

Posttraumatic Stress Disorder

COMPLETED NA

Predictors of Treatment Response to Fluoxetine in PTSD Following a Recent History of War Zone Stress Exposure

NCT00633685

Posttraumatic Stress Disorder, Combat-related

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Posttraumatic Stress Disorder (PTSD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Medication augmentation

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

Group Type ACTIVE_COMPARATOR

Medication augmentation

Intervention Type DRUG

CBT augmentation

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

Group Type ACTIVE_COMPARATOR

CBT

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Medication augmentation

Intervention Type DRUG

CBT

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Prazosin is the first choice agent in this Arm Cognitive-Behavioral Therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

43 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No