Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEET | Experimental | Peer support interventions as an adjunct to prolonged exposure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Enhanced Prolonged Exposure | Behavioral | Peer support interventions as adjunct to prolonged exposure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 10 weeks |
Not provided
Not provided
Inclusion Criteria:
Veteran participants will be individuals appropriate for PE, i.e., :
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeanette I. Harris, PhD | Minneapolis VA Health Care System, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
31 participants were referred by outpatient therapists. 9 were not interested, and 6 did not meet institutional criteria to start PE. 16 consented to interview screening. 5 did not meet criteria to start PE, 2 were lost to follow-up before starting, and one chose not to start PE.
We recruited from veterans screening for Prolonged Exposure (PE) at a Midwestern VA between 6/2017 and 3/2018. Note that the study was open between 10/2016 and 3/2018, because between 10/2016 and 2/2017 we were enrolling focus groups to refine the intervention to be tested in the clinical trial; the focus groups were not the clinical trial..
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Peer Enhanced Exposure Therapy (PEET) | Single Arm Feasibility Trial: Peer Enhanced Prolonged Exposure: Peer support interventions as adjunct to Prolonged Exposure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PEET | Single Arm Feasibility Trial: Peer Enhanced Prolonged Exposure: Peer support interventions as adjunct to prolonged exposure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | number of PE sessions attended | 10 weeks |
|
|
9 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEET | Single Arm Feasibility Trial: Peer Enhanced Prolonged Exposure: Peer support interventions as adjunct to prolonged exposure |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Irene Harris | Minneapolis VA Health Care System | 612-467-1654 | jeanette.harris2@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2017 | Mar 29, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Peer specialist led individual education and support for veterans receiving Prolonged Exposure Therapy
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Posttraumatic Stress Disorder Checklist-5 | Score range is 0-80, with higher scores indicating more PTSD symptoms | Mean | Standard Deviation | units on a scale |
|
|
| Primary | Posttraumatic Stress Disorder (PTSD) Checklist-5 | Self-report measure of PTSD symptoms; score range is 0-80, with higher scores indicating more PTSD symptoms. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
Not provided
Not provided
Not provided