PTSDEarly Phase 1SEdNCT01073657
Supported Education Pilot
A Early Phase 1 study testing Supported Education and General Peer Support in people with PTSD, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The goal of this project is to gather data necessary for a full scale trial of a supported education service for OIF/OEF veterans with PTSD. Forty Veterans with PTSD will be randomly assigned to an intervention group (N=20) that receives a weekly supported education intervention and a control group that receives… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Supported Education and General Peer Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Aug 2012
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PTSD
- OIF/OEF Service
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
About this study
Official title: Supporting Education Goals of OIF/OEF Veterans With PTSD: Pilot Process & Outcome
The goal of this project is to gather data necessary for a full scale trial of a supported education service for OIF/OEF veterans with PTSD. Forty Veterans with PTSD will be randomly assigned to an intervention group (N=20) that receives a weekly supported education intervention and a control group that receives services as usual plus an hour of attentive intervention not focused on education. We will assess and compare the number of hours of participation in community education settings and on acquiring an educational goal for the Veterans in each group.
Read the detailed description
Goal: The goal of this project is to gather data on feasibility and effect size necessary for a full scale trial of a supported education service for Operation Iraq and Enduring Freedom (OIF/OEF) veterans with PTSD that will contribute to its evidence-base. Supported education is a rehabilitation and recovery based intervention that is new to VHA services and that responds to an expressed but unmet need among these warriors with war-related trauma. We propose to conduct a pilot of a supported education service and employ a process and outcome evaluation.
Anticipated Impacts on Veterans Healthcare: Veterans with post traumatic stress disorder (PTSD) possess educational aspirations. Due to limited education and disability adjustment, many such veterans unsuccessfully locate employment or obtain entry level jobs with limited advancement opportunities. Even with current GI Bill funding increases, veterans experience non-financial barriers to their pursuit of educational goals. Supported education is a strategy developed within the civilian population that facilitates skill, career, and educational goals within post-secondary educational settings. It has been shown to increase educational engagement, participation, and completion, as well as improve empowerment and school efficacy. We hypothesize that supported education tailored to returning Veterans will result in similar outcomes.
Aims and Objectives: The goal of this project is to gather data necessary for a full scale trial of a supported education service for OIF/OEF veterans with PTSD. The following are the aims and objectives:
Aim 1: Using a randomized controlled design, assess the magnitude of the effect of a supported education service on hours of participation in community educational settings and on acquiring an educational goal. Objective: Assess the number of hours of participation in community education settings and on acquiring an educational goal for 40 Veterans with PTSD who are randomly assigned to an intervention group (N=20) that receives a weekly supported education intervention and a control group that receives services as usual plus an hour of attentive intervention not focused on education.
Aim 2. To examine whether the supported education intervention has secondary effects for improving PTSD symptoms and attitudes on recovery. Objective: Conduct pre- and post assessments of recovery attitudes and of PTSD symptoms, and then compare the control and intervention group for changes in these scores.
Aim 3. To acquire additional process information on the design and implementation of a supported education service necessary for a successful larger trial. Objective: Conduct a process evaluation of the implementation strategies for: participant recruitment, participant drop-out, technician training procedures, technician recovery promoting competence, and curriculum content and pacing using a standardized assessment, exit interviews, peer notes and study records.
- Conditions
- PTSD
- Being tested
- Supported Education, General Peer Support
- Keywords
- Rehabilitation
- 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.
Supported EducationOther
Also called Psychosocial Rehabilitation
Rehabilitation counseling using peers to achieve educational goals
General Peer SupportOther
Matched peer support for any personal goal other than education
| Study group | Role | What they receive |
|---|---|---|
| Supported Education | Experimental | Veterans received supported education services. A Veteran peer met weekly as needed with a subject for up to six months in a psycho-social rehabilitation service for meeting education goals. Goals included choosing a college, getting admitted or enrolled, and maintaining enrollment and completing classes. Receives: Other: Supported Education |
| General Peer Support | Active comparator | Matched attention was provided by a Veteran peer who met weekly with Veterans but who focused on help with any personal goal (eg, employment, housing) but not on education. Receives: Other: General Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Supported Education Process Measure"
Number of quarter hours spent in activities related to acquiring an education goal e.g., preparing applications, attending classes. Hours will be logged on a tally sheet adapted from the "Supported Education Process Measure" (Corrigan, 2009).
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 posted23 Feb 2010 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionAug 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marsha Langer Ellison, PhD MSW, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073657
- Sponsor's protocol ID
- PPO 09-254
- Acronym
- SEd
- Status last verified
- Sep 2014
- First submitted
- 18 Feb 2010
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ellison ML, Mueller L, Smelson D, Corrigan PW, Torres Stone RA, Bokhour BG, Najavits LM, Vessella JM, Drebing C. Supporting the education goals of post-9/11 veterans with self-reported PTSD symptoms: a needs assessment. Psychiatr Rehabil J. 2012 Winter;35(3):209-17. doi: 10.2975/35.3.2012.209.217.
PubMed 22246119
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Education Goals of OIF/OEF Veterans With PTSD: Pilot Process & Outcome
- ClinicalTrials.gov ID
- NCT01073657
- Acronym / sponsor ID
- SEd / PPO 09-254
- Conditions
- PTSD
- Keywords
- Rehabilitation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Posted 18 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to gather data necessary for a full scale trial of a supported education service for OIF/OEF veterans with PTSD. Forty Veterans with PTSD will be randomly assigned to an intervention group (N=20) that receives a weekly supported education intervention and a control group that receives services as usual plus an hour of attentive intervention not focused on education. We will assess and compare the number of hours of participation in community education settings and on acquiring an educational goal for the Veterans in each group.
Detailed description
Goal: The goal of this project is to gather data on feasibility and effect size necessary for a full scale trial of a supported education service for Operation Iraq and Enduring Freedom (OIF/OEF) veterans with PTSD that will contribute to its evidence-base. Supported education is a rehabilitation and recovery based intervention that is new to VHA services and that responds to an expressed but unmet need among these warriors with war-related trauma. We propose to conduct a pilot of a supported education service and employ a process and outcome evaluation.
Anticipated Impacts on Veterans Healthcare: Veterans with post traumatic stress disorder (PTSD) possess educational aspirations. Due to limited education and disability adjustment, many such veterans unsuccessfully locate employment or obtain entry level jobs with limited advancement opportunities. Even with current GI Bill funding increases, veterans experience non-financial barriers to their pursuit of educational goals. Supported education is a strategy developed within the civilian population that facilitates skill, career, and educational goals within post-secondary educational settings. It has been shown to increase educational engagement, participation, and completion, as well as improve empowerment and school efficacy. We hypothesize that supported education tailored to returning Veterans will result in similar outcomes.
Aims and Objectives: The goal of this project is to gather data necessary for a full scale trial of a supported education service for OIF/OEF veterans with PTSD. The following are the aims and objectives:
Aim 1: Using a randomized controlled design, assess the magnitude of the effect of a supported education service on hours of participation in community educational settings and on acquiring an educational goal. Objective: Assess the number of hours of participation in community education settings and on acquiring an educational goal for 40 Veterans with PTSD who are randomly assigned to an intervention group (N=20) that receives a weekly supported education intervention and a control group that receives services as usual plus an hour of attentive intervention not focused on education.
Aim 2. To examine whether the supported education intervention has secondary effects for improving PTSD symptoms and attitudes on recovery. Objective: Conduct pre- and post assessments of recovery attitudes and of PTSD symptoms, and then compare the control and intervention group for changes in these scores.
Aim 3. To acquire additional process information on the design and implementation of a supported education service necessary for a successful larger trial. Objective: Conduct a process evaluation of the implementation strategies for: participant recruitment, participant drop-out, technician training procedures, technician recovery promoting competence, and curriculum content and pacing using a standardized assessment, exit interviews, peer notes and study records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supported Education | Experimental | Other: Supported EducationVeterans received supported education services. A Veteran peer met weekly as needed with a subject for up to six months in a psycho-social rehabilitation service for meeting education goals. Goals included choosing a college, getting admitted or enrolled, and maintaining enrollment and completing classes. |
| General Peer Support | Active comparator | Other: General Peer SupportMatched attention was provided by a Veteran peer who met weekly with Veterans but who focused on help with any personal goal (eg, employment, housing) but not on education. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- PTSD
- OIF/OEF Service
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Supported EducationAlso: Psychosocial RehabilitationRehabilitation counseling using peers to achieve educational goals | Other | Supported Education |
| General Peer SupportMatched peer support for any personal goal other than education | Other | General Peer Support |
Primary outcome
"Supported Education Process Measure"
Time frame: 6 months
Number of quarter hours spent in activities related to acquiring an education goal e.g., preparing applications, attending classes. Hours will be logged on a tally sheet adapted from the "Supported Education Process Measure" (Corrigan, 2009).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22246119Ellison ML, Mueller L, Smelson D, Corrigan PW, Torres Stone RA, Bokhour BG, Najavits LM, Vessella JM, Drebing C. Supporting the education goals of post-9/11 veterans with self-reported PTSD symptoms: a needs assessment. Psychiatr Rehabil J. 2012 Winter;35(3):209-17. doi: 10.2975/35.3.2012.209.217.
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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.
Marsha Langer Ellison, PhD MSW principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Supported Education and General Peer Support in people with PTSD, run by US Department of Veterans Affairs 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 2 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 28 Apr 2015. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 18 Feb 2015). 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?
"Supported Education Process Measure" (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01073657, which also lists 1 linked publication.
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 28 Apr 2015.