Posttraumatic Stress DisorderNCT02134691
Randomized Trial of Prolonged Exposure for the Treatment of Posttraumatic Stress Disorder (PTSD)
A study testing Prolonged Exposure and Applied Relaxation in people with Posttraumatic Stress Disorder, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
This project will examine the impact of PE therapy for the treatment of PTSD with a sample of Latinos. The need to provide effective treatment to Spanish-speaking Latinos with PTSD is critical given the high prevalence of PTSD among Latinos. Furthermore, PTSD remains an under detected and under treated condition. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Prolonged Exposure and Applied Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Aug 2013to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to < 65 years
- Meet diagnostic criteria for PTSD
- Spanish speaker
- Allow recording of assessments and therapy
Who cannot join
- Significant current suicidal or homicidal ideation
- History of bipolar, schizophrenia or psychotic disorder
- Alcohol or drug abuse during the past three months
- Current high risk of being assaulted (i.e., living with domestic violence)
- Current psychotherapy to treat PTSD
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
University of Puerto Rico, Medical Sciences Campus
San Juan, 00936
About this study
This project will examine the impact of PE therapy for the treatment of PTSD with a sample of Latinos. The need to provide effective treatment to Spanish-speaking Latinos with PTSD is critical given the high prevalence of PTSD among Latinos. Furthermore, PTSD remains an under detected and under treated condition. Untreated PTSD has a substantial impact on health, functioning and quality of life. PE is one of the most empirically supported psychological interventions for PTSD. However, most studies that evidence the efficacy of PE have been conducted mainly with English-speaking Caucasian populations. This study has the potential to contribute to improvements in the well-being of Spanish-speaking Latinos with PTSD.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Prolonged Exposure, Applied Relaxation
- Keywords
- Posttraumatic Stress Disorder (PTSD), Prolonged Exposure (PE)
- 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.
Prolonged ExposureBehavioural
Applied RelaxationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure | Experimental | Behavioral: Prolonged Exposure (PE) PE is a 16 week, 90 minute culturally informed treatment program. Receives: Behavioral: Prolonged Exposure |
| Applied Relaxation | Active comparator | Behavioral: Applied Relaxation (AR) AR is a 16 week, 90 minute treatment program. Receives: Behavioral: Applied Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician Administered PTSD Scales (CAPS)
Measured: 6 months
Secondary outcomes (2)
Change in SF-12
Measured: 6 months
Change in Sheehan Disability Scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startAug 2013
- Primary completion30 Jun 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mildred Vera, University of Puerto Rico
- Investigators
- Mildred Vera, Ph.D, Principal investigator, University of Puerto Rico Medical Sciences Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134691
- Sponsor's protocol ID
- SC1MH090599
- Status last verified
- Apr 2019
- First submitted
- 7 May 2014
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Prolonged Exposure for the Treatment of Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT02134691
- Acronym / sponsor ID
- SC1MH090599
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder (PTSD), Prolonged Exposure (PE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2013
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will examine the impact of PE therapy for the treatment of PTSD with a sample of Latinos. The need to provide effective treatment to Spanish-speaking Latinos with PTSD is critical given the high prevalence of PTSD among Latinos. Furthermore, PTSD remains an under detected and under treated condition. Untreated PTSD has a substantial impact on health, functioning and quality of life. PE is one of the most empirically supported psychological interventions for PTSD. However, most studies that evidence the efficacy of PE have been conducted mainly with English-speaking Caucasian populations. This study has the potential to contribute to improvements in the well-being of Spanish-speaking Latinos with PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure | Experimental | Behavioral: Prolonged ExposureBehavioral: Prolonged Exposure (PE) PE is a 16 week, 90 minute culturally informed treatment program. |
| Applied Relaxation | Active comparator | Behavioral: Applied RelaxationBehavioral: Applied Relaxation (AR) AR is a 16 week, 90 minute treatment program. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to < 65 years
- Meet diagnostic criteria for PTSD
- Spanish speaker
- Allow recording of assessments and therapy
Key exclusion criteria (6 listed)
- Significant current suicidal or homicidal ideation
- History of bipolar, schizophrenia or psychotic disorder
- Alcohol or drug abuse during the past three months
- Current high risk of being assaulted (i.e., living with domestic violence)
- Current psychotherapy to treat PTSD
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 |
|---|---|---|
| Prolonged Exposure | Behavioural | Prolonged Exposure |
| Applied Relaxation | Behavioural | Applied Relaxation |
Primary outcome
Change in Clinician Administered PTSD Scales (CAPS)
Time frame: 6 months
2 secondary outcomes
Change in SF-12
Time frame: 6 months
Change in Sheehan Disability Scale
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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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.
Mildred Vera, Ph.D principal investigator
University of Puerto Rico Medical Sciences Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure and Applied Relaxation in people with Posttraumatic Stress Disorder, run by University of Puerto Rico at 1 site in Puerto Rico.
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 6 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: finished, as of the sponsor's last update on 17 Apr 2019. 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 Puerto Rico. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Clinician Administered PTSD Scales (CAPS) (time frame: 6 months). 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 Apr 2019.