PS-OPS: Pilot Study of Peer-Supported Online Problem-Solving Program
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: On Your Own Participants in this group will use the online program on their own for 6 weeks. |
Other: Moving Forward On Your Own
Participants in this group will use the online program on their own for 6 weeks.
|
| Experimental: 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. |
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.
|
| Placebo Comparator: Wait Participants in this group will wait 6 weeks. |
Behavioral: Wait
Participants in this group will wait 6 weeks.
|
Outcome Measures
Primary Outcome Measures
- Problem-Solving Skills, Knowledge, and Abilities Test [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.
- Problem-Solving Confidence [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 Outcome Measures
- GAD-7 Change [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.
- Posttraumatic Stress Symptoms Change [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.
- WHO-5 Well-Being Index Change [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.
- PHQ-9 Change [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.
- Client Satisfaction Questionnaire [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 Outcome Measures
- Stigma Measure (EZ-EASI) [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.
- Moving Forward Usage [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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | United States | 94304-1290 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Eve Bernstein Carlson, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Study Documents (Full-Text)
More Information
Additional Information:
- Social media marketing ad with link to join the study
- Link to REDCap eligibility screening questions
Publications
None provided.- PPO 16-323
- HX-002361-01
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | On Your Own | Peer Support | Wait |
|---|---|---|---|
| Arm/Group Description | Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks. | 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. |
| Period Title: Overall Study | |||
| STARTED | 28 | 27 | 26 |
| COMPLETED | 11 | 8 | 18 |
| NOT COMPLETED | 17 | 19 | 8 |
Baseline Characteristics
| Arm/Group Title | On Your Own | Peer Support | Wait | Total |
|---|---|---|---|---|
| Arm/Group Description | Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks. | 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. | Total of all reporting groups |
| Overall Participants | 28 | 27 | 26 | 81 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
26
92.9%
|
24
88.9%
|
26
100%
|
76
93.8%
|
| >=65 years |
2
7.1%
|
3
11.1%
|
0
0%
|
5
6.2%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
52
(10.3)
|
54
(11.0)
|
56
(9.4)
|
54
(9.4)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
10
35.7%
|
9
33.3%
|
14
53.8%
|
33
40.7%
|
| Male |
18
64.3%
|
18
66.7%
|
12
46.2%
|
48
59.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
3
10.7%
|
3
11.1%
|
2
7.7%
|
8
9.9%
|
| Not Hispanic or Latino |
25
89.3%
|
24
88.9%
|
24
92.3%
|
73
90.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
2
7.4%
|
2
7.7%
|
4
4.9%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
3.6%
|
3
11.1%
|
4
15.4%
|
8
9.9%
|
| White |
22
78.6%
|
20
74.1%
|
18
69.2%
|
60
74.1%
|
| More than one race |
4
14.3%
|
2
7.4%
|
2
7.7%
|
8
9.9%
|
| Unknown or Not Reported |
1
3.6%
|
0
0%
|
0
0%
|
1
1.2%
|
| Region of Enrollment (Count of Participants) | ||||
| United States |
28
100%
|
27
100%
|
26
100%
|
81
100%
|
Outcome Measures
| Title | Problem-Solving Skills, Knowledge, and Abilities Test |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | On Your Own | Peer Support | Wait |
|---|---|---|---|
| Arm/Group Description | Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks. | 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. |
| Measure Participants | 11 | 8 | 18 |
| Mean (Standard Deviation) [score on a scale] |
-.55
(1.64)
|
.38
(2.26)
|
-.17
(1.65)
|
| Title | Problem-Solving Confidence |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | On Your Own | Peer Support | Wait |
|---|---|---|---|
| Arm/Group Description | Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks. | 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. |
| Measure Participants | 11 | 8 | 18 |
| Mean (Standard Deviation) [score on a scale] |
1.91
(1.97)
|
2.63
(2.72)
|
0.56
(1.72)
|
| Title | GAD-7 Change |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | On Your Own | Peer Support | Wait |
|---|---|---|---|
| Arm/Group Description | Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks. | 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. |
| Measure Participants | 11 | 8 | 18 |
| Mean (Standard Deviation) [score on a scale] |
3.00
(4.80)
|
-0.87
(5.67)
|
1.06
(4.26)
|
| Title | Posttraumatic Stress Symptoms Change |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | On Your Own | Peer Support | Wait |
|---|---|---|---|
| Arm/Group Description | Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks. | 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. |
| Measure Participants | 11 | 8 | 18 |
| Mean (Standard Deviation) [score on a scale] |
4.55
(7.01)
|
3.50
(9.09)
|
1.89
(5.82)
|
| Title | WHO-5 Well-Being Index Change |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | On Your Own | Peer Support | Wait |
|---|---|---|---|
| Arm/Group Description | Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks. | 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. |
| Measure Participants | 11 | 8 | 18 |
| Mean (Standard Deviation) [score on a scale] |
-5.09
(4.30)
|
-3.12
(7.08)
|
-5.89
(5.51)
|
| Title | PHQ-9 Change |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | On Your Own | Peer Support | Wait |
|---|---|---|---|
| Arm/Group Description | Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks. | 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. |
| Measure Participants | 11 | 8 | 18 |
| Mean (Standard Deviation) [score on a scale] |
2.82
(4.69)
|
-0.75
(6.63)
|
1.61
(2.83)
|
| Title | Client Satisfaction Questionnaire |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | On Your Own | Peer Support | Wait |
|---|---|---|---|
| Arm/Group Description | Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks. | 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. |
| Measure Participants | 11 | 8 | 18 |
| Mean (Standard Deviation) [score on a scale] |
22.9
(3.09)
|
19.6
(6.09)
|
17.9
(5.03)
|
| Title | Stigma Measure (EZ-EASI) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from this measure were available for all participants because it was administered with baseline measures at the time of enrollment. |
| Arm/Group Title | On Your Own | Peer Support | Wait |
|---|---|---|---|
| Arm/Group Description | Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks. | 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. |
| Measure Participants | 28 | 27 | 18 |
| Mean (Standard Deviation) [score on a scale] |
12.5
(7.46)
|
14.5
(8.36)
|
15.7
(7.40)
|
| Title | Moving Forward Usage |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | On Your Own | Peer Support |
|---|---|---|
| Arm/Group Description | Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks. | 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. |
| Measure Participants | 28 | 27 |
| Mean (Standard Deviation) [days] |
1.2
(1.23)
|
3.0
(4.52)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | This study of an educational program was conducted entirely online or by phone and included no medical intervention, measures, or monitoring. Groups were assigned to benign educational interventions. Adverse Events are not monitored. | |||||
| Arm/Group Title | On Your Own | Peer Support | Wait | |||
| Arm/Group Description | Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks. | 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. | |||
All Cause Mortality |
||||||
| On Your Own | Peer Support | Wait | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Serious Adverse Events |
||||||
| On Your Own | Peer Support | Wait | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Other (Not Including Serious) Adverse Events |
||||||
| On Your Own | Peer Support | Wait | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Eve Carlson |
|---|---|
| Organization | National Center for PTSD |
| Phone | 6504935000 ext 24058 |
| eve.carlson@va.gov |
- PPO 16-323
- HX-002361-01