Trial Outcomes & Findings for Pilot Study Testing a Web-Based Moral Elevation Intervention for Veterans With PTSD and Moral Injury (NCT NCT03906240)

Last Updated: 2024-06-13

Results Overview

The TEI-SF is a 9-item self-report measure that assessed acceptability of the moral elevation intervention and its procedure. Items were scored from 1 to 5, with higher scores indicating greater acceptability. To assess the acceptability of the treatment in this study, we calculated descriptive statistics to determine the average score for each item across the intervention condition. The mid-point item score for this measure (range = 1-5, mid-point = 3) was used as an indicator for adequate acceptability (e.g., average/medium levels of acceptability, or higher). Thus, item scores that were greater than 3 are interpreted as supporting medium to high perceived acceptability of the intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

87 participants

Primary outcome timeframe

Follow-up assessment within 1 week of study completion.

Results posted on

2024-06-13

Participant Flow

Among 87 participants who were eligible following the initial pre-screen (phone), 48 were determined to be eligible and randomized.

Participant milestones

Participant milestones
Measure	Moral Elevation Intervention Moral Elevation Intervention (described in intervention section). Moral Elevation intervention: The intervention was administered twice per week for 8 sessions total. The intervention included two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement.	No Intervention Veterans accessed the online portal and complete session measures, but were not be presented with any intervention content (i.e., videos, journaling exercise, and goal setting exercise)
Overall Study STARTED	24	24
Overall Study COMPLETED	19	23
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Moral Elevation Intervention Moral Elevation Intervention (described in intervention section). Moral Elevation intervention: The intervention was administered twice per week for 8 sessions total. The intervention included two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement.	No Intervention Veterans accessed the online portal and complete session measures, but were not be presented with any intervention content (i.e., videos, journaling exercise, and goal setting exercise)
Overall Study Failed to complete Session 1 (essential orientation), thus excluded from future sessions.	4	0
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Pilot Study Testing a Web-Based Moral Elevation Intervention for Veterans With PTSD and Moral Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moral Elevation Intervention n=24 Participants Moral Elevation intervention: The intervention was administered twice per week for 8 sessions total. The intervention included two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement.	No Intervention n=24 Participants Veterans accessed the online portal and complete session measures, but were not be presented with any intervention content (i.e., videos, journaling exercise, and goal setting exercise)	Total n=48 Participants Total of all reporting groups
Age, Continuous	43.42 years STANDARD_DEVIATION 6.45 • n=5 Participants	45.38 years STANDARD_DEVIATION 8.85 • n=7 Participants	44.40 years STANDARD_DEVIATION 7.72 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
PTSD Symptoms	61.93 score on a scale STANDARD_DEVIATION 8.74 • n=5 Participants	53.70 score on a scale STANDARD_DEVIATION 11.46 • n=7 Participants	57.82 score on a scale STANDARD_DEVIATION 10.90 • n=5 Participants
Moral Injury Event Exposure	35.38 score on a scale STANDARD_DEVIATION 7.15 • n=5 Participants	31.58 score on a scale STANDARD_DEVIATION 8.50 • n=7 Participants	33.48 score on a scale STANDARD_DEVIATION 8.00 • n=5 Participants
Moral Injury-Related Distress	55.39 score on a scale STANDARD_DEVIATION 16.65 • n=5 Participants	57.79 score on a scale STANDARD_DEVIATION 12.95 • n=7 Participants	56.62 score on a scale STANDARD_DEVIATION 14.77 • n=5 Participants
Quality of Life Physical Domain	39.75 score on a scale STANDARD_DEVIATION 12.80 • n=5 Participants	39.58 score on a scale STANDARD_DEVIATION 19.92 • n=7 Participants	39.67 score on a scale STANDARD_DEVIATION 16.64 • n=5 Participants
Quality of Life Psychological Domain	37.05 score on a scale STANDARD_DEVIATION 14.32 • n=5 Participants	35.94 score on a scale STANDARD_DEVIATION 19.96 • n=7 Participants	36.48 score on a scale STANDARD_DEVIATION 17.25 • n=5 Participants
Quality of Life Social Domain	43.75 score on a scale STANDARD_DEVIATION 25.49 • n=5 Participants	41.67 score on a scale STANDARD_DEVIATION 20.57 • n=7 Participants	42.64 score on a scale STANDARD_DEVIATION 22.73 • n=5 Participants
Quality of Life Environment Domain	58.45 score on a scale STANDARD_DEVIATION 19.80 • n=5 Participants	57.45 score on a scale STANDARD_DEVIATION 20.32 • n=7 Participants	57.94 score on a scale STANDARD_DEVIATION 19.86 • n=5 Participants
Prosocial Behavior	53.43 score on a scale STANDARD_DEVIATION 12.31 • n=5 Participants	51.71 score on a scale STANDARD_DEVIATION 14.24 • n=7 Participants	52.55 score on a scale STANDARD_DEVIATION 13.22 • n=5 Participants

PRIMARY outcome

Timeframe: Follow-up assessment within 1 week of study completion.

Population: Among the 24 participants randomized to the treatment condition, 16 completed the post-treatment survey.

Outcome measures

Outcome measures
Measure	Moral Elevation Intervention n=16 Participants Moral Elevation intervention: The intervention was administered twice per week for 8 sessions total. The intervention included two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement.	No Intervention Veterans accessed the online portal and complete session measures, but were not be presented with any intervention content (i.e., videos, journaling exercise, and goal setting exercise)
Treatment Evaluation Inventory-Short Form (TEI-SF) 1. Acceptable way of dealing with problems related to PTSD and moral injury.	3.62 units on a scale Standard Deviation 1.01	—
Treatment Evaluation Inventory-Short Form (TEI-SF) 2. Willing to use this procedure again.	4.00 units on a scale Standard Deviation 0.95	—
Treatment Evaluation Inventory-Short Form (TEI-SF) 3. Like the procedures used in this intervention.	3.94 units on a scale Standard Deviation 0.91	—
Treatment Evaluation Inventory-Short Form (TEI-SF) 4. Believe the intervention is likely to be effective.	3.69 units on a scale Standard Deviation 0.93	—
Treatment Evaluation Inventory-Short Form (TEI-SF) 5. Believe others would experience discomfort during this intervention.	2.75 units on a scale Standard Deviation 0.92	—
Treatment Evaluation Inventory-Short Form (TEI-SF) 6. Believe intervention is likely to result in permanent improvement.	3.25 units on a scale Standard Deviation 0.67	—
Treatment Evaluation Inventory-Short Form (TEI-SF) 7. Overall, I have a positive reaction to this intervention.	3.94 units on a scale Standard Deviation 0.84	—

PRIMARY outcome

Timeframe: Repeated measure administered during online sessions 1-8 (every Monday & Thursday for 4 weeks of study participation). Participant scores for each item were averaged across all 8 sessions/measurements.

Population: This analysis of descriptive statistics across 8 sessions includes all participants who completed more than 4 sessions. Note: 3 of these participants completed the session surveys, but did not complete the final follow-up survey; thus, the discrepancy in sample sizes for outcome data.

The ESSS is a 4-item self-report measure that assessed acceptability of and satisfaction with the moral elevation exercises within the intervention condition. Items are scored from 0 to 8 with higher scores indicate greater perceived helpfulness and satisfaction with moral elevation exercises. To assess the satisfaction of the session components, we calculated descriptive statistics to determine the average score for each item across all 8 sessions (e.g., average score of item #1 for 8 repeated measurements across 8 sessions). The mid-point item score for this measure (range = 0-8, mid-point = 4) was used as an indicator for adequate satisfaction. Thus, item scores that were greater than 4 are interpreted as supporting medium to high perceived satisfaction of the intervention.

Outcome measures

Outcome measures
Measure	Moral Elevation Intervention n=19 Participants Moral Elevation intervention: The intervention was administered twice per week for 8 sessions total. The intervention included two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement.	No Intervention Veterans accessed the online portal and complete session measures, but were not be presented with any intervention content (i.e., videos, journaling exercise, and goal setting exercise)
Exercise-Specific Satisfaction Survey (ESSS) 1. Rate how helpful this session was to you.	4.95 units on a scale Standard Deviation 2.37	—
Exercise-Specific Satisfaction Survey (ESSS) 2. Rate how much you benefitted from this session's exercise.	4.64 units on a scale Standard Deviation 2.69	—
Exercise-Specific Satisfaction Survey (ESSS) 3. Rate how helpful the goal assignment was to you.	5.11 units on a scale Standard Deviation 2.59	—
Exercise-Specific Satisfaction Survey (ESSS) 4. Rate how much you were fully engaged with the material for this session.	6.22 units on a scale Standard Deviation 1.87	—

SECONDARY outcome

Timeframe: Repeated measure administered during online sessions 1-8 (every Monday & Thursday for 4 weeks of study participation). Participant scores were averaged across all 8 sessions/measurements.

The ES is a 12-item self-report measure of the degree to which state-level moral elevation is experienced. Items are scored from 0 to 4. Scores on 12 items were averaged to create a mean item score ranging from 0 to 4. Higher total scores indicate higher levels of state moral elevation. To assess the level of elevation elicited in sessions, we calculated descriptive statistics to determine the average elevation score for 8 repeated measurements across 8 sessions. The mid-point item score for this measure (range = 0-4, mid-point = 2) was used as an indicator for adequate elevation. Thus, an average elevation score that was greater than 2 is interpreted as supporting medium to high levels of elevation elicited in intervention sessions.

Outcome measures

Outcome measures
Measure	Moral Elevation Intervention n=19 Participants Moral Elevation intervention: The intervention was administered twice per week for 8 sessions total. The intervention included two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement.	No Intervention Veterans accessed the online portal and complete session measures, but were not be presented with any intervention content (i.e., videos, journaling exercise, and goal setting exercise)
Elevation Scale (ES)	1.63 units on a scale Standard Deviation 1.12	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Administered at baseline and follow-up assessment within 1 week of study completion.

Population: Analysis includes all participants who were randomized to a condition and completed the follow-up survey.

The PCL-5 is a 20-item self-report measure that assessed PTSD symptom severity. Items were scored from 0 to 4 and summed to create a total score ranging from 0 to 80. Higher scores indicate greater symptom severity. Reported findings indicate changes in PCL-5 from baseline to follow-up across both conditions. Reported findings in the Outcome Measure Data Table represent PCL-5 scores at baseline and follow up assessments within each condition.

Outcome measures

Outcome measures
Measure	Moral Elevation Intervention n=16 Participants Moral Elevation intervention: The intervention was administered twice per week for 8 sessions total. The intervention included two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement.	No Intervention n=20 Participants Veterans accessed the online portal and complete session measures, but were not be presented with any intervention content (i.e., videos, journaling exercise, and goal setting exercise)
Change From Baseline in Posttraumatic Checklist for DSM-5 (PCL-5) Baseline	61.27 Scores on a Scale Standard Deviation 8.54	52.34 Scores on a Scale Standard Deviation 11.40
Change From Baseline in Posttraumatic Checklist for DSM-5 (PCL-5) Follow-up	43.56 Scores on a Scale Standard Deviation 16.37	43.30 Scores on a Scale Standard Deviation 17.05

OTHER_PRE_SPECIFIED outcome

Timeframe: Administered at baseline and follow-up assessment within 1 week of study completion.

Population: Analysis includes all participants who were randomized to a condition and completed the follow-up survey. For the intervention condition, 1 participant did not complete this survey at follow-up.

The EMIS-M is a 17-item self-report measure of expressions of distress related to a moral injury directed at both self and others. Items were scored from 1 to 5 and summed to create a total score ranging from 17 to 85. Higher scores indicate greater moral injury-related distress. Reported findings in the Outcome Measure Data Table represent EMIS-M scores at baseline and follow-up assessments within each condition.

Outcome measures

Outcome measures
Measure	Moral Elevation Intervention n=15 Participants Moral Elevation intervention: The intervention was administered twice per week for 8 sessions total. The intervention included two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement.	No Intervention n=20 Participants Veterans accessed the online portal and complete session measures, but were not be presented with any intervention content (i.e., videos, journaling exercise, and goal setting exercise)
Changes From Baseline in Expression of Moral Injury Scale-Military Version (EMIS-M) Baseline	53.93 Scores on a Scale Standard Deviation 17.43	57.40 Scores on a Scale Standard Deviation 13.29
Changes From Baseline in Expression of Moral Injury Scale-Military Version (EMIS-M) Follow-up	53.73 Scores on a Scale Standard Deviation 17.65	53.75 Scores on a Scale Standard Deviation 13.43

OTHER_PRE_SPECIFIED outcome

Timeframe: Administered at baseline and follow-up assessment within 1 week of study completion.

The WHOQOL-BREF is a 26-item self-report measure of overall quality of life with 4 domains (physical health, psychological health, social relationships, and environment) and was used to assess perceptions of psychological health and quality of social relationships. Subscales scores are computed by summing all items for each subscale, then all scores are transformed to a range of 0-100. A higher score signifies higher or better quality of life. Reported findings in the Outcome Measure Data Table represent the WHOQOL-BREF subscale scores at baseline and follow up assessments within each condition.

Outcome measures

Outcome measures
Measure	Moral Elevation Intervention n=15 Participants Moral Elevation intervention: The intervention was administered twice per week for 8 sessions total. The intervention included two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement.	No Intervention n=20 Participants Veterans accessed the online portal and complete session measures, but were not be presented with any intervention content (i.e., videos, journaling exercise, and goal setting exercise)
Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) Physical Domain: Baseline	39.05 Scores on a scale Standard Deviation 13.05	41.43 Scores on a scale Standard Deviation 21.03
Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) Physical Domain: Follow-up	47.62 Scores on a scale Standard Deviation 15.25	41.61 Scores on a scale Standard Deviation 17.96
Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) Psychological Domain: Baseline	40.97 Scores on a scale Standard Deviation 14.89	35.63 Scores on a scale Standard Deviation 19.14
Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) Psychological Domain: Follow-up	48.61 Scores on a scale Standard Deviation 18.34	37.92 Scores on a scale Standard Deviation 20.89
Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) Social Domain: Baseline	47.92 Scores on a scale Standard Deviation 27.55	43.42 Scores on a scale Standard Deviation 21.62
Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) Social Domain: Follow-up	54.86 Scores on a scale Standard Deviation 24.74	42.98 Scores on a scale Standard Deviation 21.56
Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) Environmental Domain: Baseline	59.83 Scores on a scale Standard Deviation 18.82	60.03 Scores on a scale Standard Deviation 18.99
Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) Environmental Domain: Follow-up	64.58 Scores on a scale Standard Deviation 20.48	59.69 Scores on a scale Standard Deviation 18.30

OTHER_PRE_SPECIFIED outcome

Timeframe: Administered at baseline and follow-up assessment within 1 week of study completion.

The PS is a 16-item measure that was completed by Veterans (self-report) to assess their prosocial behaviors and tendencies to help others. Items were scored from 1 to 5 and summed to create a total score ranging from 16 to 80. Higher scores indicate greater prosocial behavior. Reported findings in the Outcome Measure Data Table represent PS scores at baseline and follow-up assessments within each condition.

Outcome measures

Outcome measures
Measure	Moral Elevation Intervention n=15 Participants Moral Elevation intervention: The intervention was administered twice per week for 8 sessions total. The intervention included two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement.	No Intervention n=20 Participants Veterans accessed the online portal and complete session measures, but were not be presented with any intervention content (i.e., videos, journaling exercise, and goal setting exercise)
Changes From Baseline in Prosocialness Scale (PS) - Self-report Baseline	53.60 Scores on a Scale Standard Deviation 12.79	52.95 Scores on a Scale Standard Deviation 13.98
Changes From Baseline in Prosocialness Scale (PS) - Self-report Follow-up	52.33 Scores on a Scale Standard Deviation 15.93	53.00 Scores on a Scale Standard Deviation 13.40

Adverse Events

Moral Elevation Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Intervention

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

Dr. Adam McGuire

VISN 17 Center of Excellence for Research on Returning War Veterans

Phone: 254-297-5173

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place