PTSDPEETNCT02818114
Peer Enhanced Prolonged Exposure
A study testing Peer Enhanced Prolonged Exposure in people with PTSD, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The investigators plan to develop and test an intervention using peer specialists (Veterans who have managed PTSD and completed PE) to provide support services for Veterans using prolonged exposure therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Peer Enhanced Prolonged Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2016to 30 Oct 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran participants will be individuals appropriate for PE, i.e., :
- Veterans who are currently seeking PE
- meet DSM-5 criteria for PTSD or subthreshold PTSD
- are competent to consent to research
Who cannot join
- Veteran participants do not have levels of other types of psychopathology that would prevent successful participation in the intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
About this study
Official title: Peer Enhanced Exposure Therapy (PEET)
The investigators plan to develop and test an intervention using peer specialists (Veterans who have managed PTSD and completed PE) to provide support services for Veterans using prolonged exposure therapy.
Read the detailed description
The investigators will use qualitative data from Veterans and PE providers to revise the investigators' manualized intervention for peer support services, then complete a feasibility trial to assess the feasibility and acceptability of Peer Enhanced Prolonged Exposure
- Conditions
- PTSD
- Being tested
- Peer Enhanced Prolonged Exposure
- Keywords
- PTSD, Prolonged Exposure, Peer Support
- 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.
Peer Enhanced Prolonged ExposureBehavioural
Also called PEET
Peer support interventions as adjunct to prolonged exposure
| Study group | Role | What they receive |
|---|---|---|
| PEET | Experimental | Peer support interventions as an adjunct to prolonged exposure Receives: Behavioral: Peer Enhanced Prolonged Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
PE Sessions Attended
Number of PE Sessions attended during 10 weeks of participation in study. 10 is the maximum, 0 is the minimum. Higher numbers of sessions attended are an indication of better engagement in treatment.
Measured: 10 weeks
Posttraumatic Stress Disorder (PTSD) Checklist-5
Self-report measure of PTSD symptoms; score range is 0-80, with higher scores indicating more PTSD symptoms.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start16 Oct 2016
- Primary completion16 Jun 2018
- Study completion30 Oct 2018
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 PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Peer specialist led individual education and support for veterans receiving Prolonged Exposure Therapy
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jeanette I. Harris, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818114
- Sponsor's protocol ID
- D2188-P
- Acronym
- PEET
- Status last verified
- Jun 2019
- First submitted
- 27 Jun 2016
- Last updated
- 2 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Enhanced Exposure Therapy (PEET)
- ClinicalTrials.gov ID
- NCT02818114
- Acronym / sponsor ID
- PEET / D2188-P
- Conditions
- PTSD
- Keywords
- PTSD, Prolonged Exposure, Peer Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 16 Oct 2016 (actual)
- Primary completion
- 16 Jun 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Posted 24 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to develop and test an intervention using peer specialists (Veterans who have managed PTSD and completed PE) to provide support services for Veterans using prolonged exposure therapy.
Detailed description
The investigators will use qualitative data from Veterans and PE providers to revise the investigators' manualized intervention for peer support services, then complete a feasibility trial to assess the feasibility and acceptability of Peer Enhanced Prolonged Exposure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Peer specialist led individual education and support for veterans receiving Prolonged Exposure Therapy
| Arm | Type | Receives |
|---|---|---|
| PEET | Experimental | Behavioral: Peer Enhanced Prolonged ExposurePeer support interventions as an adjunct to prolonged exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran participants will be individuals appropriate for PE, i.e., :
Key exclusion criteria (1 listed)
- Veteran participants do not have levels of other types of psychopathology that would prevent successful participation in the intervention
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 |
|---|---|---|
| Peer Enhanced Prolonged ExposureAlso: PEETPeer support interventions as adjunct to prolonged exposure | Behavioural | PEET |
Primary outcome
PE Sessions Attended
Time frame: 10 weeks
Number of PE Sessions attended during 10 weeks of participation in study. 10 is the maximum, 0 is the minimum. Higher numbers of sessions attended are an indication of better engagement in treatment.
Posttraumatic Stress Disorder (PTSD) Checklist-5
Time frame: 10 weeks
Self-report measure of PTSD symptoms; score range is 0-80, with higher scores indicating more PTSD symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jeanette I. Harris, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Enhanced Prolonged Exposure in people with PTSD, run by VA Office of Research and Development 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 1 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 2 Jul 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2019). 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?
PE Sessions Attended (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 2 Jul 2019.