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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01542372
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder (PTSD)	Drug: Medication augmentation; Behavioral: CBT	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• 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
• Actual Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Medication augmentation In one arm, the patients will be given a medication augmentation for SSRI/SSRN-resistant PTSD	Drug: Medication augmentation; Other Names: 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 Names: Cognitive-Behavioral Therapy

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 43 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Devon E. Hinton, Associate Professor of Psychiatry, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01542372
• Other Study ID Numbers: MH094312
• First Posted: Mar 2, 2012
• Last Update Posted: May 17, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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, Associate Professor of Psychiatry, 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; Prazosin

Study Results

Participant Flow

Recruitment Details	Patients were recruited in primary care clinics
Pre-assignment Detail	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.

Arm/Group Title	Medication Augmentation (Prazosin)	CBT Augmentation
Arm/Group Description	In this arm, the patients were given a medication augmentation for SSRI/SSRN-resistant PTSD, with the preferred first-line agent being prazosin. Prazosin as first-line agent: Prazosin .5 to 2 mg	In this arm, patients were given CBT to treat SSRI/SSRN-resistant PTSD. Cognitive Behavioral Therapy for PTSD: This is a culturally sensitive CBT for the treatment of PTSD
Period Title: Overall Study
STARTED	11	11
COMPLETED	11	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Step I: SSRI/SSRN Treatment of PTSD
Arm/Group Description	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
Overall Participants	114
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	114 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.8 (4.8)
Sex: Female, Male (Count of Participants)
Female	70 61.4%
Male	44 38.6%
Region of Enrollment (participants) [Number]
United States	114 100%

Outcome Measures

1. Primary Outcome

Title	Change in the PTSD Checklist (PCL) at 12 Weeks in Step II
Description	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.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Patients with PTSD checklist scores of 30 or above were eligible for Step II, which was medication augmentation or CBT augmentation.

Arm/Group Title	Medication Augmentation (Prazosin)	CBT Augmentation
Arm/Group Description	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	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
Measure Participants	11	11
Mean (Standard Deviation) [units on a scale]	-5.0 (9.6)	-11.4 (7.5)

2. Secondary Outcome

Title	Change in the HSCL Anxiety Scale at 12 Weeks in Step II
Description	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.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medication Augmentation (Prazosin)	CBT Augmentation
Arm/Group Description	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	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
Measure Participants	11	11
Mean (Standard Deviation) [units on a scale]	-0.4 (0.6)	-0.6 (0.9)

3. Secondary Outcome

Title	Change in the HSCL Depression Scale at 12 Weeks in Step II
Description	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.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medication Augmentation (Prazosin)	CBT Augmentation
Arm/Group Description	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	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
Measure Participants	11	11
Mean (Standard Deviation) [units on a scale]	-0.3 (0.7)	-0.5 (0.7)

4. Secondary Outcome

Title	Change in the SCL Anger Severity at 12 Weeks in Step II
Description	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.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medication Augmentation (Prazosin)	CBT Augmentation
Arm/Group Description	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	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
Measure Participants	11	11
Mean (Standard Deviation) [units on a scale]	-0.3 (0.8)	-0.9 (0.7)

5. Secondary Outcome

Title	Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II
Description	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.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medication Augmentation (Prazosin)	CBT Augmentation
Arm/Group Description	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	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
Measure Participants	11	11
Mean (Standard Deviation) [units on a scale]	-0.5 (0.6)	-0.9 (0.5)

6. Secondary Outcome

Title	Change in the SF-12 at 12 Weeks in Step II
Description	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.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medication Augmentation (Prazosin)	CBT Augmentation
Arm/Group Description	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	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
Measure Participants	11	11
Mean (Standard Deviation) [units on a scale]	6.8 (9.3)	10.2 (9.0)

Adverse Events

Time Frame	1 year 7 months
Adverse Event Reporting Description	We followed the clinical trials definitions.
Arm/Group Title	Step I and Step 2
Arm/Group Description	Step 1 is treatment with SSRI or SSRN. Step 2 is Medication or CBT augmentation.
All Cause Mortality
	Step I and Step 2
	Affected / at Risk (%)	# Events
Total	0/114 (0%)
Serious Adverse Events
	Step I and Step 2
	Affected / at Risk (%)	# Events
Total	0/114 (0%)
Other (Not Including Serious) Adverse Events
	Step I and Step 2
	Affected / at Risk (%)	# Events
Total	0/114 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.