Trial Outcomes & Findings for Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD (NCT NCT01542372)

NCT ID: NCT01542372

Last Updated: 2017-05-17

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

114 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2017-05-17

Participant Flow

Patients were recruited in primary care clinics

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.

Participant milestones

Participant milestones
Measure	Medication Augmentation (Prazosin) 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	CBT Augmentation 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
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Step I: SSRI/SSRN Treatment of PTSD n=114 Participants 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
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	114 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	52.8 years STANDARD_DEVIATION 4.8 • n=93 Participants
Sex: Female, Male Female	70 Participants n=93 Participants
Sex: Female, Male Male	44 Participants n=93 Participants
Region of Enrollment United States	114 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

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

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.

Outcome measures

Outcome measures
Measure	CBT Augmentation n=11 Participants 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	Medication Augmentation (Prazosin) n=11 Participants 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
Change in the PTSD Checklist (PCL) at 12 Weeks in Step II	-11.4 units on a scale Standard Deviation 7.5	-5.0 units on a scale Standard Deviation 9.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CBT Augmentation n=11 Participants 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	Medication Augmentation (Prazosin) n=11 Participants 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
Change in the HSCL Anxiety Scale at 12 Weeks in Step II	-0.6 units on a scale Standard Deviation 0.9	-0.4 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CBT Augmentation n=11 Participants 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	Medication Augmentation (Prazosin) n=11 Participants 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
Change in the HSCL Depression Scale at 12 Weeks in Step II	-0.5 units on a scale Standard Deviation 0.7	-0.3 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CBT Augmentation n=11 Participants 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	Medication Augmentation (Prazosin) n=11 Participants 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
Change in the SCL Anger Severity at 12 Weeks in Step II	-0.9 units on a scale Standard Deviation 0.7	-0.3 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CBT Augmentation n=11 Participants 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	Medication Augmentation (Prazosin) n=11 Participants 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
Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II	-0.9 units on a scale Standard Deviation 0.5	-0.5 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CBT Augmentation n=11 Participants 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	Medication Augmentation (Prazosin) n=11 Participants 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
Change in the SF-12 at 12 Weeks in Step II	10.2 units on a scale Standard Deviation 9.0	6.8 units on a scale Standard Deviation 9.3

Adverse Events

Step I and Step 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Devon Hinton

Massachusetts

Phone: 617-620-4522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place