Problem-solvingPS-OPSNCT03555435
Pilot Study of Peer-Supported Online Problem-Solving Program
A study testing Moving Forward On Your Own, Moving Forward with Peer Support and Wait in people with Problem-solving and Well-being, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Problem-solving, Well-being, Peer Support
- What is being tested?
- Moving Forward On Your Own, Moving Forward with Peer Support and Wait
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
About this study
Official title: Pilot Study of Standalone and Peer Supported Online Problem Solving Program in Veterans With Untreated Mental Health Problems
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.
Read the 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.
- Being tested
- Moving Forward On Your Own, Moving Forward with Peer Support, Wait
- Keywords
- Problem-solving, Stigma reduction, Peer support, Online mental health program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moving Forward On Your OwnOther
Participants in this group will use the online program on their own for 6 weeks.
Moving Forward with Peer SupportBehavioural
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.
WaitBehavioural
Participants in this group will wait 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| On Your Own | Experimental | Participants in this group will use the online program on their own for 6 weeks. Receives: Other: Moving Forward On Your Own |
| Peer Support | Experimental | 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. Receives: Behavioral: Moving Forward with Peer Support |
| Wait | Placebo comparator | Participants in this group will wait 6 weeks. Receives: Behavioral: Wait |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline to study end (6 weeks)
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.
Measured: change from baseline to study end (6 weeks)
Secondary outcomes (5)
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.
Measured: change from baseline to study end (6 weeks)
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.
Measured: change from baseline to study end (6 weeks)
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.
Measured: change from baseline to study end (6 weeks)
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.
Measured: change from baseline to study end (6 weeks)
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.
Measured: at study end (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start28 Sep 2018
- Primary completion30 Sep 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Problem-solvingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eve Bernstein Carlson, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555435
- Sponsor's protocol ID
- PPO 16-323
- Other IDs
- HX-002361-01
- Acronym
- PS-OPS
- Status last verified
- Jul 2023
- First submitted
- 1 Jun 2018
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset containing IPD reported in a publication will be created and shared. Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication. Prior to distribution, a local privacy officer will certify that all datasets contains no PHI. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access.
Publications
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.
PubMed 35023846
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Standalone and Peer Supported Online Problem Solving Program in Veterans With Untreated Mental Health Problems
- ClinicalTrials.gov ID
- NCT03555435
- Acronym / sponsor ID
- PS-OPS / PPO 16-323
- Keywords
- Problem-solving, Stigma reduction, Peer support, Online mental health program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Posted 16 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| On Your Own | Experimental | Other: Moving Forward On Your OwnParticipants in this group will use the online program on their own for 6 weeks. |
| Peer Support | Experimental | Behavioral: Moving Forward with Peer SupportParticipants 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 | Placebo comparator | Behavioral: WaitParticipants in this group will wait 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moving Forward On Your OwnParticipants in this group will use the online program on their own for 6 weeks. | Other | On Your Own |
| Moving Forward with Peer SupportParticipants 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. | Behavioural | Peer Support |
| WaitParticipants in this group will wait 6 weeks. | Behavioural | Wait |
Primary outcome
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.
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.
5 secondary outcomes
GAD-7 Change
Time frame: change from baseline to study end (6 weeks)
Posttraumatic Stress Symptoms Change
Time frame: change from baseline to study end (6 weeks)
WHO-5 Well-Being Index Change
Time frame: change from baseline to study end (6 weeks)
PHQ-9 Change
Time frame: change from baseline to study end (6 weeks)
Client Satisfaction Questionnaire
Time frame: at study end (6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35023846Possemato 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.
- Social media marketing ad with link to join the studyLink provided by the sponsor.
- Link to REDCap eligibility screening questionsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset containing IPD reported in a publication will be created and shared. Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication. Prior to distribution, a local privacy officer will certify that all datasets contains no PHI. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eve Bernstein Carlson, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moving Forward On Your Own, Moving Forward with Peer Support and Wait in people with Problem-solving and Well-being, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Problem-Solving Skills, Knowledge, and Abilities Test (time frame: change from baseline to study end (6 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03555435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.