NCT03906240

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

Completed NA Results posted Last updated 13 June 2024

What this trial tests

NA trial testing Moral Elevation intervention in Posttraumatic Stress Disorder in 87 participants. Completed in 1 December 2021.

Timeline

2 March 2020

Primary endpoint
30 November 2021

1 December 2021

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	87
Start date	2 March 2020
Primary completion	30 November 2021
Estimated completion	1 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Moral Elevation intervention

Conditions studied

• Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →
• Moral Injury — all drugs for Moral Injury →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Posttraumatic Stress Disorder or Moral Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Treatment Evaluation Inventory-Short Form (TEI-SF) Primary · Follow-up assessment within 1 week of study completion.

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 gre

1. Acceptable way of dealing with problems related to PTSD and moral injury.

Group	Value	95% CI
Moral Elevation Intervention	3.62	± 1.01

2. Willing to use this procedure again.

Group	Value	95% CI
Moral Elevation Intervention	4.00	± 0.95

3. Like the procedures used in this intervention.

Group	Value	95% CI
Moral Elevation Intervention	3.94	± 0.91

4. Believe the intervention is likely to be effective.

Group	Value	95% CI
Moral Elevation Intervention	3.69	± 0.93

5. Believe others would experience discomfort during this intervention.

Group	Value	95% CI
Moral Elevation Intervention	2.75	± 0.92

6. Believe intervention is likely to result in permanent improvement.

Group	Value	95% CI
Moral Elevation Intervention	3.25	± 0.67

7. Overall, I have a positive reaction to this intervention.

Group	Value	95% CI
Moral Elevation Intervention	3.94	± 0.84

Exercise-Specific Satisfaction Survey (ESSS) Primary · 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.

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 =

1. Rate how helpful this session was to you.

Group	Value	95% CI
Moral Elevation Intervention	4.95	± 2.37

2. Rate how much you benefitted from this session's exercise.

Group	Value	95% CI
Moral Elevation Intervention	4.64	± 2.69

3. Rate how helpful the goal assignment was to you.

Group	Value	95% CI
Moral Elevation Intervention	5.11	± 2.59

4. Rate how much you were fully engaged with the material for this session.

Group	Value	95% CI
Moral Elevation Intervention	6.22	± 1.87

Elevation Scale (ES) Secondary · 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 ave

Group	Value	95% CI
Moral Elevation Intervention	1.63	± 1.12

Change From Baseline in Posttraumatic Checklist for DSM-5 (PCL-5) Secondary · Administered at baseline and follow-up assessment within 1 week of study completion.

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.

Baseline

Group	Value	95% CI
Moral Elevation Intervention	61.27	± 8.54
No Intervention	52.34	± 11.40

Follow-up

Group	Value	95% CI
Moral Elevation Intervention	43.56	± 16.37
No Intervention	43.30	± 17.05

Changes From Baseline in Expression of Moral Injury Scale-Military Version (EMIS-M) Secondary · Administered at baseline and follow-up assessment within 1 week of study completion.

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.

Baseline

Group	Value	95% CI
Moral Elevation Intervention	53.93	± 17.43
No Intervention	57.40	± 13.29

Follow-up

Group	Value	95% CI
Moral Elevation Intervention	53.73	± 17.65
No Intervention	53.75	± 13.43

Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) Secondary · 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 conditio

Physical Domain: Baseline

Group	Value	95% CI
Moral Elevation Intervention	39.05	± 13.05
No Intervention	41.43	± 21.03

Physical Domain: Follow-up

Group	Value	95% CI
Moral Elevation Intervention	47.62	± 15.25
No Intervention	41.61	± 17.96

Psychological Domain: Baseline

Group	Value	95% CI
Moral Elevation Intervention	40.97	± 14.89
No Intervention	35.63	± 19.14

Psychological Domain: Follow-up

Group	Value	95% CI
Moral Elevation Intervention	48.61	± 18.34
No Intervention	37.92	± 20.89

Social Domain: Baseline

Group	Value	95% CI
Moral Elevation Intervention	47.92	± 27.55
No Intervention	43.42	± 21.62

Social Domain: Follow-up

Group	Value	95% CI
Moral Elevation Intervention	54.86	± 24.74
No Intervention	42.98	± 21.56

Environmental Domain: Baseline

Group	Value	95% CI
Moral Elevation Intervention	59.83	± 18.82
No Intervention	60.03	± 18.99

Environmental Domain: Follow-up

Group	Value	95% CI
Moral Elevation Intervention	64.58	± 20.48
No Intervention	59.69	± 18.30

Changes From Baseline in Prosocialness Scale (PS) - Self-report Secondary · 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.

Baseline

Group	Value	95% CI
Moral Elevation Intervention	53.60	± 12.79
No Intervention	52.95	± 13.98

Follow-up

Group	Value	95% CI
Moral Elevation Intervention	52.33	± 15.93
No Intervention	53.00	± 13.40

Sponsor's own description

Given the prevalence of posttraumatic stress disorder (PTSD) and moral injury in combat Veterans and the limitations to current treatments, novel approaches are needed to target both PTSD and moral injury and directly impact psychosocial growth and functional recovery. One potential way to address this critical need is through moral elevation-a positive emotional state described as feeling uplifted and inspired by others' virtuous actions. This study will pilot a web-based moral elevation intervention with Operations Enduring Freedom, Iraqi Freedom, and New Dawn Veterans who experienced a morally injurious event and with a PTSD diagnosis. If Veterans are willing and able to complete an online moral elevation intervention and it has beneficial effects, then moral elevation could be feasibly utilized as a tool to reverse the negative effects of trauma and facilitate recovery. Data from this study will be used to develop larger clinical trials to test if this intervention significantly improves PTSD symptoms and moral injury distress and enhances social functioning.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Assessing Interpersonal Impact of Veterans with PTSD and Moral Injury: A Case Study of How Significant Others Perceive Veterans Undergoing a Positive Psychology Intervention.
   McGuire AP, Erickson TM, Nabulsi E. · · 2024 · PMID 40129677 · DOI 10.1037/int0000317
2. Response styles to positive affect during a positive psychology intervention for veterans with PTSD and moral injury: Preliminary results from a moral elevation intervention pilot trial.
   McGuire AP, Rodenbaugh M, Howard BAN, Contractor AA. · · 2025 · PMID 39207432 · DOI 10.1037/tra0001774