Posttraumatic Stress Disorder (PTSD)Phase 4NCT01542372
Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD
A Phase 4 study testing Medication augmentation and CBT in people with Posttraumatic Stress Disorder (PTSD), run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 43 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Medication augmentation and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Mar 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 43 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PTSD;
- PCL great or equal to 44;
- Survivor of the Cambodian genocide;
- At least 7 years old at the time of the Cambodian genocide
Who cannot join
- Pregnant;
- Active suicidality;
- Mental retardation;
- Organic mental disorder;
- Bipolar disorder;
- Alcohol dependence;
- Marijuana dependence;
- Unable to give conformed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Two Stepped Care Models for PTSD Among Cambodian Refugees With PTSD
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Medication augmentation, CBT
- Keywords
- PTSD, Cognitive behavioral therapy (CBT), Medication augmentation, Treatment-resistant PTSD, Cambodian refugees, Culturally sensitive treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication augmentationDrug
Also called Prazosin is the first choice agent in this Arm
CBTBehavioural
Also called Cognitive-Behavioral Therapy
| Study group | Role | What they receive |
|---|---|---|
| Medication augmentation | Active comparator | In one arm, the patients will be given a medication augmentation for SSRI/SSRN-resistant PTSD Receives: Drug: Medication augmentation |
| CBT augmentation | Active comparator | In this arm, patients will receive CBT to treat SSRI/SSRN-resistant PTSD. Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (5)
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.
Measured: Baseline and 12 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Inadequate flow of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devon E. Hinton, Massachusetts General Hospital
- Investigators
- Devon E. Hinton, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542372
- Sponsor's protocol ID
- MH094312
- Status last verified
- Apr 2017
- First submitted
- 21 Feb 2012
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Stepped Care Models for PTSD Among Cambodian Refugees With PTSD
- ClinicalTrials.gov ID
- NCT01542372
- Acronym / sponsor ID
- MH094312
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- PTSD, Cognitive behavioral therapy (CBT), Medication augmentation, Treatment-resistant PTSD, Cambodian refugees, Culturally sensitive treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate flow of patients
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication augmentation | Active comparator | Drug: Medication augmentationIn one arm, the patients will be given a medication augmentation for SSRI/SSRN-resistant PTSD |
| CBT augmentation | Active comparator | Behavioral: CBTIn this arm, patients will receive CBT to treat SSRI/SSRN-resistant PTSD. |
Who may qualify
- Ages
- 43 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PTSD;
- PCL great or equal to 44;
- Survivor of the Cambodian genocide;
- At least 7 years old at the time of the Cambodian genocide
Key exclusion criteria (8 listed)
- Pregnant;
- Active suicidality;
- Mental retardation;
- Organic mental disorder;
- Bipolar disorder;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication augmentationAlso: Prazosin is the first choice agent in this Arm | Drug | Medication augmentation |
| CBTAlso: Cognitive-Behavioral Therapy | Behavioural | CBT augmentation |
Primary outcome
Change in the PTSD Checklist (PCL) at 12 Weeks in Step II
Time frame: 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.
5 secondary outcomes
Change in the HSCL Anxiety Scale at 12 Weeks in Step II
Time frame: Baseline and 12 weeks
Change in the HSCL Depression Scale at 12 Weeks in Step II
Time frame: Baseline and 12 weeks
Change in the SCL Anger Severity at 12 Weeks in Step II
Time frame: Baseline and 12 weeks
Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II
Time frame: Baseline and 12 weeks
Change in the SF-12 at 12 Weeks in Step II
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devon E. Hinton, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medication augmentation and CBT in people with Posttraumatic Stress Disorder (PTSD), run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the PTSD Checklist (PCL) at 12 Weeks in Step II (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.