Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The goal of this proposed study is to conduct a pilot trial of a web-based moral elevation intervention to determine if such an intervention is a feasible and acceptable therapeutic approach for Operations Enduring Freedom, Iraqi Freedom, and New Dawn Veterans with distress related to posttraumatic stress disorder (PTSD) and moral injury (MI). This study will also assess the feasibility of randomization, retention, and completion of a no-treatment condition (i.e., comparison group) in preparation for future randomized controlled trials (RCTs). The sample will include 24 Veterans (12 per group). The online intervention consists of two exercises per week for one month, totaling eight sessions. Sessions will include watching validated videos that elicit moral elevation and recalling moments when one experienced moral elevation in daily life, paired with journaling about one's reactions to witnessed virtuous behavior. Participants in the intervention condition will also be presented with a brief goal to be completed prior to the next session to facilitate greater social engagement. Participants randomized to the no-treatment condition will access the same online portal twice per week, but will not be exposed to any intervention components. All participants will complete brief self-report measures at each online session. All participants will also complete self-report measures at baseline and 1-month follow-up that will assess PTSD symptoms, MI distress, prosocial behavior, and quality of social relationships. At the follow-up assessment, participants randomized to the intervention condition will complete an individual qualitative interview with a member of the study team to assess acceptability and satisfaction with the intervention and proposed methodology, which will be coded and analyzed to inform future clinical trials. To supplement self-report measures, all participants will invite a significant other (e.g., spouse, close friend) to complete measures based on observations of the Veteran's behavior and social functioning at baseline and 1-month follow-up. Feasibility of recruitment, retention, and completion of the intervention will be analyzed by tracking the number of participants retained at each stage of the study, as well as the number of sessions completed in the intervention. Results from this study will be used to develop an RCT with a larger sample size to determine the efficacy of a moral elevation intervention and assess whether this novel approach leads to unique beneficial outcomes regarding PTSD and moral injury distress.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention | No Intervention | Veterans will access the online portal and complete session measures, but will not be presented with any intervention content (i.e., videos, journaling exercise, and goal setting exercise) | |
| Moral Elevation Intervention | Experimental | Moral Elevation Intervention (described in intervention section). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moral Elevation intervention | Behavioral | The intervention will be administered twice per week for 8 sessions total. The intervention will include two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Evaluation Inventory-Short Form (TEI-SF) | 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. | Follow-up assessment within 1 week of study completion. |
| Exercise-Specific Satisfaction Survey (ESSS) | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Elevation Scale (ES) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Posttraumatic Checklist for DSM-5 (PCL-5) | 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. |
Inclusion Criteria:
Veteran Participant Inclusion Criteria:
Significant Other Participant Inclusion Criteria:
Exclusion Criteria:
Veteran Participant Exclusion Criteria:
Significant Other Participant Exclusion Criteria:
- None
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adam P. McGuire, PhD | Central Texas Veterans Health Care System, Temple, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Texas Veterans Health Care System, Temple, TX | Temple | Texas | 76504 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39207432 | Derived | McGuire AP, Rodenbaugh M, Howard BAN, Contractor AA. 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. Psychol Trauma. 2025 Feb;17(2):457-465. doi: 10.1037/tra0001774. Epub 2024 Aug 29. |
Not provided
Not provided
All collected IPD
Not provided
1 year after publication
Not provided
Not provided
Among 87 participants who were eligible following the initial pre-screen (phone), 48 were determined to be eligible and randomized.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Moral Elevation Intervention | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Evaluation Inventory-Short Form (TEI-SF) | 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. | Among the 24 participants randomized to the treatment condition, 16 completed the post-treatment survey. | Posted | Mean | Standard Deviation | units on a scale | Follow-up assessment within 1 week of study completion. |
|
6 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moral Elevation Intervention | 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. |
Not provided
Not provided
The main aim of this pilot trial was to test the feasibility and acceptability of the intervention. Therefore, statistical tests used for secondary/targeted outcomes should be interpreted with caution given the small sample size. Additionally, larger samples are needed to formally test between-group comparisons in change scores. Lastly, the state elevation measure did not perform optimally in this sample, but newer scales have been developed since this trial and should be used in future studies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam McGuire | VISN 17 Center of Excellence for Research on Returning War Veterans | 254-297-5173 | adam.mcguire@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2021 | Nov 28, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2021 | Nov 28, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2020 | Nov 28, 2022 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Participants are randomized to either an intervention condition or no-treatment condition. The intervention condition is accessed through an online portal and includes the moral elevation intervention with intervention content and session goals to facilitate social engagement. The no-treatment condition includes accessing the same online portal, but without any intervention content and is limited to repeated self-report measures for the duration of the study.
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| Administered at baseline and follow-up assessment within 1 week of study completion. |
| Changes From Baseline in Expression of Moral Injury Scale-Military Version (EMIS-M) | 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. | Administered at baseline and follow-up assessment within 1 week of study completion. |
| Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) | 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. | Administered at baseline and follow-up assessment within 1 week of study completion. |
| Changes From Baseline in Prosocialness Scale (PS) - Self-report | 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. | Administered at baseline and follow-up assessment within 1 week of study completion. |
| Withdrawal by Subject |
|
| 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| PTSD Symptoms | Posttraumatic Checklist for DSM-5, total score ranging from 0 to 80. Higher scores indicate greater symptom severity. (PCL-5; Weathers et al., 2013). | Mean | Standard Deviation | score on a scale |
|
| Moral Injury Event Exposure | Moral Injury Events Scale, total range is 11 to 66, with higher scores reflecting greater moral injury. (MIES; Nash et al., 2013). | Mean | Standard Deviation | score on a scale |
|
| Moral Injury-Related Distress | Expression of Moral Injury Scale, total score ranging from 17 to 85. Higher scores indicate greater moral injury-related distress. (EMIS; Currier et al., 2018). | Mean | Standard Deviation | score on a scale |
|
| Quality of Life | The World Health Organization Quality of Life includes 4 subscales: Physical Domain (7 items), Psychological Domain (6 items), Social Domain (3 items), and Environment Domain (8 items). 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. (WHOQOL-BREF Group et al., 1998). | Mean | Standard Deviation | score on a scale |
|
| Prosocial Behavior | Prosocialness Scale, total score ranging from 16 to 80. Higher scores indicate greater prosocial behavior. (PS; Caprara et al., 2005). | Mean | Standard Deviation | score on a scale |
|
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. |
|
|
| Primary | Exercise-Specific Satisfaction Survey (ESSS) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
|
|
|
| Secondary | Elevation Scale (ES) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
|
|
|
| Other Pre-specified | Change From Baseline in Posttraumatic Checklist for DSM-5 (PCL-5) | 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. | Analysis includes all participants who were randomized to a condition and completed the follow-up survey. | Posted | Mean | Standard Deviation | Scores on a Scale | Administered at baseline and follow-up assessment within 1 week of study completion. |
|
|
|
|
| Other Pre-specified | Changes From Baseline in Expression of Moral Injury Scale-Military Version (EMIS-M) | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | Administered at baseline and follow-up assessment within 1 week of study completion. |
|
|
|
|
| Other Pre-specified | Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Administered at baseline and follow-up assessment within 1 week of study completion. |
|
|
|
|
| Other Pre-specified | Changes From Baseline in Prosocialness Scale (PS) - Self-report | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | Administered at baseline and follow-up assessment within 1 week of study completion. |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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) | 0 | 24 | 0 | 24 | 0 | 24 |
Not provided
Not provided
Not provided
|
| 4. Rate how much you were fully engaged with the material for this session. |
|
| t-test, 2 sided |
t = 3.48 |
| .002 |
| Cohen's d |
| 0.78 |
| 2-Sided |
| 95 |
| 0.35 |
| 1.38 |
| Superiority |
| t-test, 2 sided |
t = 2.30 |
| .033 |
| Cohen's d |
| 0.51 |
| 2-Sided |
| 95 |
| 0.08 |
| 1.25 |
| Superiority |
| Psychological Domain: Baseline |
|
| Psychological Domain: Follow-up |
|
| Social Domain: Baseline |
|
| Social Domain: Follow-up |
|
| Environmental Domain: Baseline |
|
| Environmental Domain: Follow-up |
|
| t-test, 2 sided |
t = 2.87 |
| .012 |
| Cohen's d |
| 0.74 |
| 2-Sided |
| 95 |
| 0.26 |
| 1.55 |
| Superiority |
| Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up. | t-test, 2 sided | t = 0.08 | .941 | Cohen's d | 0.02 | 2-Sided | 95 | -0.43 | 0.55 | Superiority |
| Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up. | t-test, 2 sided | t = 1.14 | .270 | Cohen's d | 0.25 | 2-Sided | 95 | -0.17 | 0.79 | Superiority |
| t-test, 2 sided |
t = 0.05 |
| .975 |
| Cohen's d |
| 0.01 |
| 2-Sided |
| 95 |
| -0.53 |
| 0.42 |
| Superiority |