Pilot Study of Peer-Supported Online Problem-Solving Program
PS-OPS
Pilot Study of Standalone and Peer Supported Online Problem Solving Program in Veterans With Untreated Mental Health Problems
2 other identifiers
interventional
81
1 country
1
Brief Summary
Many Veterans with mental health care needs go without care due to stigma, practical problems with getting services, and a high value on self-sufficiency. VHA has developed online programs aimed at fostering MH that are easy to access and may be more acceptable than psychotherapy. The purpose of this study is to learn whether peer-supported use of an online problem-solving course is acceptable and helpful and whether the study data can be collected online. Results of this pilot study would inform a larger study of the impact on problem-solving and mental health of a non-stigmatizing, online program - with and without peer support. If effective, peer supported online programs would improve the quality of care to Veterans with unmet mental health needs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2018
1 active site
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 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2018
CompletedStudy Start
First participant enrolled
September 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedResults Posted
Study results publicly available
December 16, 2020
CompletedJuly 27, 2023
July 1, 2023
1 year
June 1, 2018
November 17, 2020
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Problem-Solving Skills, Knowledge, and Abilities Test
The Problem-Solving Skills, Knowledge, \& Abilities Test is a brief, multiple-choice test that measures mastery of the basic concepts and skills that are included in the Moving Forward program. Scores on the test can range from 0 to 12 with higher scores indicating greater problem-solving skills, knowledge, and abilities.
change from baseline to study end (6 weeks)
Problem-Solving Confidence
The Problem-Solving Confidence Test assesses participant's confidence in his/her own problem solving abilities. Scores on this measure can range from 0 to 9 with higher scores indicating greater problem-solving confidence.
change from baseline to study end (6 weeks)
Secondary Outcomes (5)
GAD-7 Change
change from baseline to study end (6 weeks)
Posttraumatic Stress Symptoms Change
change from baseline to study end (6 weeks)
WHO-5 Well-Being Index Change
change from baseline to study end (6 weeks)
PHQ-9 Change
change from baseline to study end (6 weeks)
Client Satisfaction Questionnaire
at study end (6 weeks)
Other Outcomes (2)
Stigma Measure (EZ-EASI)
measured once at baseline
Moving Forward Usage
daily for 6 weeks
Study Arms (3)
On Your Own
EXPERIMENTALParticipants in this group will use the online program on their own for 6 weeks.
Peer Support
EXPERIMENTALParticipants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.
Wait
PLACEBO COMPARATORParticipants in this group will wait 6 weeks.
Interventions
Participants in this group will use the online program on their own for 6 weeks.
Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.
Eligibility Criteria
You may qualify if:
- A Veteran of one of the U.S. military services, including National Guard and Reserves.
- Positive screen (score of 1 or more) on the PHQ-2 or GAD-2.
- Access to a phone and to a desktop or laptop computer with internet access.
- Willingness to be randomized to one of three conditions.
- Willingness to work with a Peer Support Specialist.
You may not qualify if:
- An active suicide plan.
- Changes in psychoactive medications in the past month.
- MH treatment in the past 6 months, including treatment from a PC-MHI team member.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207, United States
Related Publications (1)
Possemato K, Wu J, Greene C, MacQueen R, Blonigen D, Wade M, Owen J, Keane T, Brief D, Lindley S, Prins A, Mackintosh MA, Carlson E. Web-Based Problem-solving Training With and Without Peer Support in Veterans With Unmet Mental Health Needs: Pilot Study of Feasibility, User Acceptability, and Participant Engagement. J Med Internet Res. 2022 Jan 13;24(1):e29559. doi: 10.2196/29559.
PMID: 35023846DERIVED
Related Links
Limitations and Caveats
This was a pilot study primarily aimed at studying feasibility and acceptability of online study enrollment and data collection that was not powered to allow definitive conclusions from analyses. Study end measures were available from only 47% of participants randomized at baseline, indicating that online data collection is insufficient to obtain complete measures after the baseline.
Results Point of Contact
- Title
- Eve Carlson
- Organization
- National Center for PTSD
Study Officials
- PRINCIPAL INVESTIGATOR
Eve Bernstein Carlson, PhD
VA Palo Alto Health Care System, Palo Alto, CA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2018
First Posted
June 13, 2018
Study Start
September 28, 2018
Primary Completion
September 30, 2019
Study Completion
November 30, 2019
Last Updated
July 27, 2023
Results First Posted
December 16, 2020
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Datasets will be made available within 1 year of publication.
- Access Criteria
- Guidance on request and distribution processes will be provided by ORD. Those requesting data will be asked to sign a Letter of Agreement.
A de-identified, anonymized dataset containing IPD reported in a publication will be created and shared. Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication. Prior to distribution, a local privacy officer will certify that all datasets contains no PHI. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access.