Trial · NCT01542372
Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD
NCT01542372, Phase 4, Terminated, Massachusetts General Hospital; results first posted 2017-05-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD. Trials, record NCT01542372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01542372
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD
- NCT number
- NCT01542372
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 114 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Interventions
- Medication augmentation, CBT
- First posted
- 2012-03-02
- Last updated
- 2017-05-17
- Results first posted
- 2017-05-17
- Limitations and 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.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the PTSD Checklist (PCL) at 12 Weeks in Step II | Baseline and 12 weeks | Patients with PTSD checklist scores of 30 or above were eligible for Step II, which was medication augmentation or CBT augmentation. | units on a scale | MEAN |
| SECONDARY | Change in the HSCL Anxiety Scale at 12 Weeks in Step II | Baseline and 12 weeks | units on a scale | MEAN | |
| SECONDARY | Change in the HSCL Depression Scale at 12 Weeks in Step II | Baseline and 12 weeks | units on a scale | MEAN | |
| SECONDARY | Change in the SCL Anger Severity at 12 Weeks in Step II | Baseline and 12 weeks | units on a scale | MEAN | |
| SECONDARY | Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II | Baseline and 12 weeks | units on a scale | MEAN | |
| SECONDARY | Change in the SF-12 at 12 Weeks in Step II | Baseline and 12 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the PTSD Checklist (PCL) at 12 Weeks in Step II | Medication Augmentation (Prazosin) | -5.0 | Standard Deviation 9.6 | units on a scale | |
| Change in the PTSD Checklist (PCL) at 12 Weeks in Step II | CBT Augmentation | -11.4 | Standard Deviation 7.5 | units on a scale | |
| Change in the HSCL Anxiety Scale at 12 Weeks in Step II | Medication Augmentation (Prazosin) | -0.4 | Standard Deviation 0.6 | units on a scale | |
| Change in the HSCL Anxiety Scale at 12 Weeks in Step II | CBT Augmentation | -0.6 | Standard Deviation 0.9 | units on a scale | |
| Change in the HSCL Depression Scale at 12 Weeks in Step II | Medication Augmentation (Prazosin) | -0.3 | Standard Deviation 0.7 | units on a scale | |
| Change in the HSCL Depression Scale at 12 Weeks in Step II | CBT Augmentation | -0.5 | Standard Deviation 0.7 | units on a scale | |
| Change in the SCL Anger Severity at 12 Weeks in Step II | Medication Augmentation (Prazosin) | -0.3 | Standard Deviation 0.8 | units on a scale | |
| Change in the SCL Anger Severity at 12 Weeks in Step II | CBT Augmentation | -0.9 | Standard Deviation 0.7 | units on a scale | |
| Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II | Medication Augmentation (Prazosin) | -0.5 | Standard Deviation 0.6 | units on a scale | |
| Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II | CBT Augmentation | -0.9 | Standard Deviation 0.5 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Medication Augmentation (Prazosin) | 11 | |
| Overall Study | STARTED | CBT Augmentation | 11 | |
| Overall Study | COMPLETED | Medication Augmentation (Prazosin) | 11 | |
| Overall Study | COMPLETED | CBT Augmentation | 11 | |
| Overall Study | NOT COMPLETED | Medication Augmentation (Prazosin) | 0 | |
| Overall Study | NOT COMPLETED | CBT Augmentation | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Step I and Step 2 | 0 | 114 |
| Total, other adverse events | Step I and Step 2 | 0 | 114 |
| Total, serious adverse events | Step I and Step 2 | 0 | 114 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01542372
GET https://conductscience.org/api/trials/v1/NCT01542372/registered