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Pilot Study of Peer-Supported Online Problem-Solving Program

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03555435
Acronym
PS-OPS
Enrollment
81
Registered
2018-06-13
Start date
2018-09-28
Completion date
2019-11-30
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Problem-solving, Stigma reduction, Peer support, Online mental health program

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.

Interventions

OTHERMoving Forward On Your Own

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

BEHAVIORALMoving 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.

BEHAVIORALWait

Participants in this group will wait 6 weeks.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Problem-Solving Confidencechange 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.
Problem-Solving Skills, Knowledge, and Abilities Testchange 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.

Secondary

MeasureTime frameDescription
Posttraumatic Stress Symptoms Changechange 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.
PHQ-9 Changechange 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.
Client Satisfaction Questionnaireat 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.
WHO-5 Well-Being Index Changechange 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.
GAD-7 Changechange 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.

Other

MeasureTime frameDescription
Stigma Measure (EZ-EASI)measured once at baselineThe 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.
Moving Forward Usagedaily for 6 weeksUsage was assessed by total number of days logging in to online course Moving Forward. This data was collected daily and automatically during study participation.

Countries

United States

Participant flow

Participants by arm

ArmCount
On Your Own
Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.
28
Peer Support
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.
27
Wait
Wait: Participants in this group will wait 6 weeks.
26
Total81

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up17198

Baseline characteristics

CharacteristicOn Your OwnPeer SupportWaitTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants3 Participants0 Participants5 Participants
Age, Categorical
Between 18 and 65 years
26 Participants24 Participants26 Participants76 Participants
Age, Continuous52 years
STANDARD_DEVIATION 10.3
54 years
STANDARD_DEVIATION 11
56 years
STANDARD_DEVIATION 9.4
54 years
STANDARD_DEVIATION 9.4
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants3 Participants2 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants24 Participants24 Participants73 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants2 Participants2 Participants4 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants3 Participants4 Participants8 Participants
Race (NIH/OMB)
More than one race
4 Participants2 Participants2 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
White
22 Participants20 Participants18 Participants60 Participants
Region of Enrollment
United States
28 Participants27 Participants26 Participants81 Participants
Sex: Female, Male
Female
10 Participants9 Participants14 Participants33 Participants
Sex: Female, Male
Male
18 Participants18 Participants12 Participants48 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

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.

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

ArmMeasureValue (MEAN)Dispersion
On Your OwnProblem-Solving Confidence1.91 score on a scaleStandard Deviation 1.97
Peer SupportProblem-Solving Confidence2.63 score on a scaleStandard Deviation 2.72
WaitProblem-Solving Confidence0.56 score on a scaleStandard Deviation 1.72
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.

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

ArmMeasureValue (MEAN)Dispersion
On Your OwnProblem-Solving Skills, Knowledge, and Abilities Test-.55 score on a scaleStandard Deviation 1.64
Peer SupportProblem-Solving Skills, Knowledge, and Abilities Test.38 score on a scaleStandard Deviation 2.26
WaitProblem-Solving Skills, Knowledge, and Abilities Test-.17 score on a scaleStandard Deviation 1.65
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.

Time frame: at study end (6 weeks)

ArmMeasureValue (MEAN)Dispersion
On Your OwnClient Satisfaction Questionnaire22.9 score on a scaleStandard Deviation 3.09
Peer SupportClient Satisfaction Questionnaire19.6 score on a scaleStandard Deviation 6.09
WaitClient Satisfaction Questionnaire17.9 score on a scaleStandard Deviation 5.03
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.

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

ArmMeasureValue (MEAN)Dispersion
On Your OwnGAD-7 Change3.00 score on a scaleStandard Deviation 4.8
Peer SupportGAD-7 Change-0.87 score on a scaleStandard Deviation 5.67
WaitGAD-7 Change1.06 score on a scaleStandard Deviation 4.26
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.

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

ArmMeasureValue (MEAN)Dispersion
On Your OwnPHQ-9 Change2.82 score on a scaleStandard Deviation 4.69
Peer SupportPHQ-9 Change-0.75 score on a scaleStandard Deviation 6.63
WaitPHQ-9 Change1.61 score on a scaleStandard Deviation 2.83
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.

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

ArmMeasureValue (MEAN)Dispersion
On Your OwnPosttraumatic Stress Symptoms Change4.55 score on a scaleStandard Deviation 7.01
Peer SupportPosttraumatic Stress Symptoms Change3.50 score on a scaleStandard Deviation 9.09
WaitPosttraumatic Stress Symptoms Change1.89 score on a scaleStandard Deviation 5.82
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.

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

ArmMeasureValue (MEAN)Dispersion
On Your OwnWHO-5 Well-Being Index Change-5.09 score on a scaleStandard Deviation 4.3
Peer SupportWHO-5 Well-Being Index Change-3.12 score on a scaleStandard Deviation 7.08
WaitWHO-5 Well-Being Index Change-5.89 score on a scaleStandard Deviation 5.51
Other Pre-specified

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.

Time frame: daily for 6 weeks

Population: Data from this measure were available for all participants because they were collected automatically via programming that collected and reported log ins to use the course. The course was mounted on a learning management platform and participants were given anonymized links to access the course.

ArmMeasureValue (MEAN)Dispersion
On Your OwnMoving Forward Usage1.2 daysStandard Deviation 1.23
Peer SupportMoving Forward Usage3.0 daysStandard Deviation 4.52
Other Pre-specified

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.

Time frame: measured once at baseline

Population: Data from this measure were available for all participants because it was administered with baseline measures at the time of enrollment.

ArmMeasureValue (MEAN)Dispersion
On Your OwnStigma Measure (EZ-EASI)12.5 score on a scaleStandard Deviation 7.46
Peer SupportStigma Measure (EZ-EASI)14.5 score on a scaleStandard Deviation 8.36
WaitStigma Measure (EZ-EASI)15.7 score on a scaleStandard Deviation 7.4

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026