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Inadequate flow of patients
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication augmentation | Active Comparator | In one arm, the patients will be given a medication augmentation for SSRI/SSRN-resistant PTSD |
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| CBT augmentation | Active Comparator | In this arm, patients will receive CBT to treat SSRI/SSRN-resistant PTSD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication augmentation | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the HSCL Anxiety Scale at 12 Weeks in Step II | 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. | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devon E. Hinton, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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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.
Patients were recruited in primary care clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients who meet inclusion criteria for Step 1 such as PTSD and impairment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients with PTSD checklist scores of 30 or above were eligible for Step II, which was medication augmentation or CBT augmentation. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
1 year 7 months
We followed the clinical trials definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Step I and Step 2 | Step 1 is treatment with SSRI or SSRN. Step 2 is Medication or CBT augmentation. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Devon Hinton | Massachusetts | 617-620-4522 | DHINTON1@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| CBT |
| Behavioral |
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| Change in the HSCL Depression Scale at 12 Weeks in Step II | 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. | Baseline and 12 weeks |
| Change in the SCL Anger Severity at 12 Weeks in Step II | 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. | Baseline and 12 weeks |
| Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II | 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. | Baseline and 12 weeks |
| Change in the SF-12 at 12 Weeks in Step II | 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. | Baseline and 12 weeks |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 |
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| Secondary | Change in the HSCL Anxiety Scale at 12 Weeks in Step II | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
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| Secondary | Change in the HSCL Depression Scale at 12 Weeks in Step II | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
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| Secondary | Change in the SCL Anger Severity at 12 Weeks in Step II | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
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| Secondary | Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
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| Secondary | Change in the SF-12 at 12 Weeks in Step II | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
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| 114 |
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| 114 |
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| 114 |
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