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Completed

NCT Number: NCT03555435

Pilot Study of Peer-Supported Online Problem-Solving Program

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.

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Key information

Conditions

Problem-solving Online Mental Health Program Peer Support Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moving Forward On Your Own

Other

Participants in this group will use the online program on their own for 6 weeks.

Moving Forward with Peer Support

Behavioral

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

Behavioral

Participants in this group will wait 6 weeks.

Primary outcomes

  1. Problem-Solving Skills, Knowledge, and Abilities Test

    Time frame: change from baseline to study end (6 weeks)

    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.

  2. Problem-Solving Confidence

    Time frame: change from baseline to study end (6 weeks)

    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.

Secondary outcomes

  1. GAD-7 Change

    Time frame: change from baseline to study end (6 weeks)

    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.

  2. Posttraumatic Stress Symptoms Change

    Time frame: change from baseline to study end (6 weeks)

    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.

  3. WHO-5 Well-Being Index Change

    Time frame: change from baseline to study end (6 weeks)

    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.

  4. PHQ-9 Change

    Time frame: change from baseline to study end (6 weeks)

    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.

  5. Client Satisfaction Questionnaire

    Time frame: at study end (6 weeks)

    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.

Other outcomes

  1. Stigma Measure (EZ-EASI)

    Time frame: measured once at baseline

    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.

  2. Moving Forward Usage

    Time frame: daily for 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: PS-OPS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 13, 2018
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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