Pilot Study of Peer-Supported Online Problem-Solving Program

Well-being Clinical Trial

— PS-OPS  

Official title:

Pilot Study of Standalone and Peer Supported Online Problem Solving Program in Veterans With Untreated Mental Health Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555435
• Other study ID #: PPO 16-323
• Secondary ID: HX-002361-01
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Online Mental Health Program
• Peer Support
• Problem-solving
• Well-being

Intervention

Other:
• Moving Forward On Your Own
Participants in this group will use the online program on their own for 6 weeks.

Behavioral:
• Moving Forward with Peer Support
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.
• Wait
Participants in this group will wait 6 weeks.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stigma Measure (EZ-EASI)	The Endorsed and Anticipated Stigma Inventory (EASI) is a tool for assessing different dimensions of stigma-related beliefs about mental health among military and veteran populations. Findings based on a national sample of U.S. veterans deployed in support of Operation Enduring Freedom (OEF) in Afghanistan or Operation Iraqi Freedom (OIF) in Iraq suggest that the EASI is a psychometrically sound instrument. Specifically, results revealed evidence for the internal consistency reliability, content validity, convergent and discriminant validity, and discriminative validity of EASI scales. Total scores on 13 items used range from 0 to 39. Higher scores represent greater endorsement of stigma-related beliefs.	measured once at baseline
Other	Moving Forward Usage	Usage was assessed by total number of days logging in to online course Moving Forward. This data was collected daily and automatically during study participation.	daily for 6 weeks
Primary	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)
Primary	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	GAD-7 Change	The GAD-7 assesses the severity of anxiety symptoms associated with generalized anxiety in terms of the proportion of days assessed in which the symptoms were present. Score range 0-21. Positive values for change from baseline to study end represent decreases in anxiety. Negative values for change from baseline to end represent increases in anxiety.	change from baseline to study end (6 weeks)
Secondary	Posttraumatic Stress Symptoms Change	Symptom change was measured by 7 items from the Screen for Posttraumatic Stress Symptoms (SPTSS) and 4 items from the Dissociative Symptoms Scale (DSS). Scores for all items could range from 0 to 47. Scores on change could range from -47 to 47. Positive values for change from baseline to study end represent reductions in PTSD symptoms.	change from baseline to study end (6 weeks)
Secondary	WHO-5 Well-Being Index Change	The World Health Organization Well-Being Index (WHO-5) is a widely-used 5-item measure assessing subjective psychological well-being. Its design for use around the world and translation into 30 languages are indicative of its usefulness as a measure for a diverse population. Score range 0-25. Positive changes from baseline to study end represent decreases in well-being. Negative values for change from baseline to end represent increases in well-being.	change from baseline to study end (6 weeks)
Secondary	PHQ-9 Change	The PHQ-9 assesses the severity of depression in terms of the proportion of days assessed in which the symptoms were present. Score range 0-27. Positive values for change from baseline to end represent reductions in depression. Negative values for change from baseline to end represent increases in depression.	change from baseline to study end (6 weeks)
Secondary	Client Satisfaction Questionnaire	The Client Satisfaction Questionnaire (CSQ) is a standardized, widely-used measure of customer satisfaction with health services and programs. Total scores on the 7-items we used range from 7 to 28. Higher scores represent greater satisfaction.	at study end (6 weeks)

External Links

•   Link to REDCap eligibility screening questions
•   Social media marketing ad with link to join the study