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

Mass General Brigham

Status and phase: Terminated; Phase 4

Conditions: Posttraumatic Stress Disorder (PTSD)

Treatments: Drug: Medication augmentation; Behavioral: CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT01542372

MH094312

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 43+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

Medication augmentation

Active Comparator group

Description:

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

Treatment:

Drug: Medication augmentation

CBT augmentation

Active Comparator group

Description:

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

Treatment:

Behavioral: CBT