Clinical trial NCT03555435: Pilot Study of Peer-Supported Online Problem-Solving Program
Official title: Pilot Study of Standalone and Peer Supported Online Problem Solving Program in Veterans With Untreated Mental Health Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem-solving
Well-being
Peer Support
Online Mental Health Program
Keywords: Problem-solving
Stigma reduction
Peer support
Online mental health program
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-06-13
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with three groups: 1) Use of online problem-solving program on one's own. 2) Use of online problem-solving program with peer support. 3) Wait control group.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Approval will be obtained from VA primary care staff leaders at Palo Alto Division and VA Palo Alto Community Based Outpatient Clinics (CBOCs) to mail notes and a study information card to patients who do not have stop codes for mental health or integrated care in their EMR records for the past six months. The study information cards will describe the study, how to enroll, and will direct the Veteran to REDCap eligibility screening questions. When eligibility is confirmed, REDCap will automatically alert research assistant to enroll participant and randomize.

Primary Care Mental Health Integration staff at each clinic may also refer patients to the study by entering referral information directly into secure, encrypted REDCap files or by handing the patient a study information card.

Community veterans will be invited via social media marketing. Ads will link to a study web site. Study web site will link potential participants to REDCap eligibility screening questions. When eligibility is confirmed, REDCap will automatically alert research assistant to enroll participant and randomize.

Veterans who decide to be in the study will be assigned by chance to one of three groups: An On Your Own group, a Peer Support group, or a Wait group. Veterans assigned to take the Moving Forward course with peer support or on their own will complete the course online and practice the problem-solving skills they learned for six weeks. Finishing the Moving Forward course takes a total of about four hours. Veterans in the peer support group will speak with a Veteran who is experienced with the course on the phone for 15 to 20 minutes once a week during the study about using the ideas and exercises in the course to solve problems. Veterans assigned to the wait group will answer questions online about problem-solving skills and their well-being at the start and after six weeks). They will be able to take the course if they would like to after the six weeks have passed. Veterans in the On Your Own and Peer Support groups will answer questions online at the beginning, middle, and end of the study about problem-solving skills, their opinions about the course and about peer support (if they got it), and their well-being. This will take 10 to 15 minutes each time.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Problem-Solving Skills, Knowledge, and Abilities Test
timeFrame: change from baseline to study end (6 weeks)
measure: Problem-Solving Confidence
timeFrame: change from baseline to study end (6 weeks)
Secondary outcomes:
measure: GAD-7 Change
timeFrame: change from baseline to study end (6 weeks)
measure: Posttraumatic Stress Symptoms Change
timeFrame: change from baseline to study end (6 weeks)
measure: WHO-5 Well-Being Index Change
timeFrame: change from baseline to study end (6 weeks)
measure: PHQ-9 Change
timeFrame: change from baseline to study end (6 weeks)
measure: Client Satisfaction Questionnaire
timeFrame: at study end (6 weeks)
Other outcomes:
measure: Stigma Measure (EZ-EASI)
timeFrame: measured once at baseline
measure: Moving Forward Usage
timeFrame: daily for 6 weeks
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Eve Bernstein Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.