NCT02818114

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 16, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 24, 2019

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

1.7 years

First QC Date

June 27, 2016

Results QC Date

March 29, 2019

Last Update Submit

June 25, 2019

Conditions

Keywords

PTSDProlonged ExposurePeer Support

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

PEET

EXPERIMENTAL

Peer support interventions as an adjunct to prolonged exposure

Behavioral: Peer Enhanced Prolonged Exposure

Interventions

Peer support interventions as adjunct to prolonged exposure

Also known as: PEET
PEET

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Veteran participants do not have levels of other types of psychopathology that would prevent successful participation in the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
J. Irene Harris
Organization
Minneapolis VA Health Care System

Study Officials

  • Jeanette I. Harris, PhD

    Minneapolis VA Health Care System, Minneapolis, MN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Peer specialist led individual education and support for veterans receiving Prolonged Exposure Therapy
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2016

First Posted

June 29, 2016

Study Start

October 16, 2016

Primary Completion

June 16, 2018

Study Completion

October 30, 2018

Last Updated

July 2, 2019

Results First Posted

June 24, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations