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

Two Stepped Care Models for PTSD Among Cambodian Refugees With PTSD

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01542372

Enrollment

114

Registered

2012-03-02

Start date

2012-04-30

Completion date

2014-03-31

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

PTSD, Cognitive behavioral therapy (CBT), Medication augmentation, Treatment-resistant PTSD, Cambodian refugees, Culturally sensitive treatment

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.

Interventions

DRUGMedication augmentation

BEHAVIORALCBT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

43 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change in the PTSD Checklist (PCL) at 12 Weeks in Step II	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

Measure	Time frame	Description
Change in the HSCL Anxiety Scale at 12 Weeks in Step II	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	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	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	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	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.

Countries

United States

Participant flow

Recruitment details

Patients were recruited in primary care clinics

Pre-assignment details

In Step 1 of the protocol, patients were given an SSRI/SSRN to determine eligibility for Step 2. If a patient still had PTSD (PCL \> 30) after Step I, the patient was assigned to an arm of Step 2, which was Medication or CBT augmentation. Of 114 patients started in Step I, 22 met criteria for entry to Step 2, the study proper, addressing study aims.

Participants by arm

Arm	Count
Step I: SSRI/SSRN Treatment of PTSD At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation	114
Total	114

Baseline characteristics

Characteristic	Step I: SSRI/SSRN Treatment of PTSD
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	114 Participants
Age, Continuous	52.8 years STANDARD_DEVIATION 4.8
Region of Enrollment United States	114 participants
Sex: Female, Male Female	70 Participants
Sex: Female, Male Male	44 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 114
other Total, other adverse events	0 / 114
serious Total, serious adverse events	0 / 114

Outcome results

Primary

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.