Trial Outcomes & Findings for Pilot Study of Peer-Supported Online Problem-Solving Program (NCT NCT03555435)

NCT ID: NCT03555435

Last Updated: 2023-07-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 81 participants
• Primary outcome timeframe: change from baseline to study end (6 weeks)
• Results posted on: 2023-07-27

Participant Flow

Participant milestones

Measure	On Your Own Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.	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.	Wait Wait: Participants in this group will wait 6 weeks.
Overall Study STARTED	28	27	26
Overall Study COMPLETED	11	8	18
Overall Study NOT COMPLETED	17	19	8

Reasons for withdrawal

Measure	On Your Own Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.	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.	Wait Wait: Participants in this group will wait 6 weeks.
Overall Study Lost to Follow-up	17	19	8

Baseline Characteristics

Pilot Study of Peer-Supported Online Problem-Solving Program

Baseline characteristics by cohort

Measure	On Your Own n=28 Participants Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.	Peer Support n=27 Participants 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 n=26 Participants Wait: Participants in this group will wait 6 weeks.	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	24 Participants n=7 Participants	26 Participants n=5 Participants	76 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Age, Continuous	52 years STANDARD_DEVIATION 10.3 • n=5 Participants	54 years STANDARD_DEVIATION 11.0 • n=7 Participants	56 years STANDARD_DEVIATION 9.4 • n=5 Participants	54 years STANDARD_DEVIATION 9.4 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	12 Participants n=5 Participants	48 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	24 Participants n=7 Participants	24 Participants n=5 Participants	73 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	20 Participants n=7 Participants	18 Participants n=5 Participants	60 Participants n=4 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	28 Participants n=5 Participants	27 Participants n=7 Participants	26 Participants n=5 Participants	81 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	On Your Own n=11 Participants Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.	Peer Support n=8 Participants 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 n=18 Participants Wait: Participants in this group will wait 6 weeks.
Problem-Solving Skills, Knowledge, and Abilities Test	-.55 score on a scale Standard Deviation 1.64	.38 score on a scale Standard Deviation 2.26	-.17 score on a scale Standard Deviation 1.65

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	On Your Own n=11 Participants Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.	Peer Support n=8 Participants 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 n=18 Participants Wait: Participants in this group will wait 6 weeks.
Problem-Solving Confidence	1.91 score on a scale Standard Deviation 1.97	2.63 score on a scale Standard Deviation 2.72	0.56 score on a scale Standard Deviation 1.72

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	On Your Own n=11 Participants Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.	Peer Support n=8 Participants 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 n=18 Participants Wait: Participants in this group will wait 6 weeks.
GAD-7 Change	3.00 score on a scale Standard Deviation 4.80	-0.87 score on a scale Standard Deviation 5.67	1.06 score on a scale Standard Deviation 4.26

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	On Your Own n=11 Participants Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.	Peer Support n=8 Participants 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 n=18 Participants Wait: Participants in this group will wait 6 weeks.
Posttraumatic Stress Symptoms Change	4.55 score on a scale Standard Deviation 7.01	3.50 score on a scale Standard Deviation 9.09	1.89 score on a scale Standard Deviation 5.82

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	On Your Own n=11 Participants Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.	Peer Support n=8 Participants 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 n=18 Participants Wait: Participants in this group will wait 6 weeks.
WHO-5 Well-Being Index Change	-5.09 score on a scale Standard Deviation 4.30	-3.12 score on a scale Standard Deviation 7.08	-5.89 score on a scale Standard Deviation 5.51

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	On Your Own n=11 Participants Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.	Peer Support n=8 Participants 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 n=18 Participants Wait: Participants in this group will wait 6 weeks.
PHQ-9 Change	2.82 score on a scale Standard Deviation 4.69	-0.75 score on a scale Standard Deviation 6.63	1.61 score on a scale Standard Deviation 2.83

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	On Your Own n=11 Participants Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.	Peer Support n=8 Participants 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 n=18 Participants Wait: Participants in this group will wait 6 weeks.
Client Satisfaction Questionnaire	22.9 score on a scale Standard Deviation 3.09	19.6 score on a scale Standard Deviation 6.09	17.9 score on a scale Standard Deviation 5.03

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	On Your Own n=28 Participants Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.	Peer Support n=27 Participants 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 n=18 Participants Wait: Participants in this group will wait 6 weeks.
Stigma Measure (EZ-EASI)	12.5 score on a scale Standard Deviation 7.46	14.5 score on a scale Standard Deviation 8.36	15.7 score on a scale Standard Deviation 7.40

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	On Your Own n=28 Participants Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.	Peer Support n=27 Participants 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 Wait: Participants in this group will wait 6 weeks.
Moving Forward Usage	1.2 days Standard Deviation 1.23	3.0 days Standard Deviation 4.52	—

Adverse Events

On Your Own

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peer Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eve Carlson

National Center for PTSD

Phone: 6504935000

Email: eve.carlson@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place