Moral Injury, Posttraumatic Stress Disorder
Conditions
Keywords
Web-Based Intervention, Pilot Study, Moral Elevation, Veterans, PTSD, Moral Injury
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMoral Elevation intervention
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Veteran Participant Inclusion Criteria: * 18 years of age * OEF/OIF/OND Veteran enrolled in CTVHCS * English-speaking and able to provide written informed consent * Internet access for web-based sessions and measures * Current PTSD diagnosis based on medical chart review or screen positively for a probable diagnosis based on empirically-validated cutoffs on the PTSD Checklist for DSM-5 * Screen positively for experiencing 1 morally injurious event and endorse some distress (\>4 on any item) related to that event based on the Moral Injury Events Scale (MIES) * Willing to complete study procedures and identify an SO who will complete observational measures * Willing to be randomized Significant Other Participant Inclusion Criteria: * 18 years of age * Designated as a Significant Other by the Veteran participant, and the Veteran participant has provided consent for the study team to contact that potential Significant Other * English-speaking * Internet access for web-based observational measures * Interact with the Veteran \>1 time per week * Willing to complete study procedures
Exclusion criteria
Veteran Participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Evaluation Inventory-Short Form (TEI-SF) | 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 greater than 3 are interpreted as supporting medium to high perceived acceptability of the intervention. |
| Exercise-Specific Satisfaction Survey (ESSS) | 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 = 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elevation Scale (ES) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Posttraumatic Checklist for DSM-5 (PCL-5) | 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. |
| Changes From Baseline in Prosocialness Scale (PS) - Self-report | 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. |
| Changes From Baseline in Expression of Moral Injury Scale-Military Version (EMIS-M) | 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. |
| Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Among 87 participants who were eligible following the initial pre-screen (phone), 48 were determined to be eligible and randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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) | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Moral Elevation Intervention | No Intervention | Total |
|---|---|---|---|
| Age, Continuous | 43.42 years STANDARD_DEVIATION 6.45 | 45.38 years STANDARD_DEVIATION 8.85 | 44.40 years STANDARD_DEVIATION 7.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 2 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 22 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Moral Injury Event Exposure | 35.38 score on a scale STANDARD_DEVIATION 7.15 | 31.58 score on a scale STANDARD_DEVIATION 8.5 | 33.48 score on a scale STANDARD_DEVIATION 8 |
| Moral Injury-Related Distress | 55.39 score on a scale STANDARD_DEVIATION 16.65 | 57.79 score on a scale STANDARD_DEVIATION 12.95 | 56.62 score on a scale STANDARD_DEVIATION 14.77 |
| Prosocial Behavior | 53.43 score on a scale STANDARD_DEVIATION 12.31 | 51.71 score on a scale STANDARD_DEVIATION 14.24 | 52.55 score on a scale STANDARD_DEVIATION 13.22 |
| PTSD Symptoms | 61.93 score on a scale STANDARD_DEVIATION 8.74 | 53.70 score on a scale STANDARD_DEVIATION 11.46 | 57.82 score on a scale STANDARD_DEVIATION 10.9 |
| Quality of Life Environment Domain | 58.45 score on a scale STANDARD_DEVIATION 19.8 | 57.45 score on a scale STANDARD_DEVIATION 20.32 | 57.94 score on a scale STANDARD_DEVIATION 19.86 |
| Quality of Life Physical Domain | 39.75 score on a scale STANDARD_DEVIATION 12.8 | 39.58 score on a scale STANDARD_DEVIATION 19.92 | 39.67 score on a scale STANDARD_DEVIATION 16.64 |
| Quality of Life Psychological Domain | 37.05 score on a scale STANDARD_DEVIATION 14.32 | 35.94 score on a scale STANDARD_DEVIATION 19.96 | 36.48 score on a scale STANDARD_DEVIATION 17.25 |
| Quality of Life Social Domain | 43.75 score on a scale STANDARD_DEVIATION 25.49 | 41.67 score on a scale STANDARD_DEVIATION 20.57 | 42.64 score on a scale STANDARD_DEVIATION 22.73 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) White | 6 Participants | 10 Participants | 16 Participants |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moral Elevation Intervention | Exercise-Specific Satisfaction Survey (ESSS) | 1. Rate how helpful this session was to you. | 4.95 units on a scale | Standard Deviation 2.37 |
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | Treatment Evaluation Inventory-Short Form (TEI-SF) | 2. Willing to use this procedure again. | 4.00 units on a scale | Standard Deviation 0.95 |
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
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.
Time frame: 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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moral Elevation Intervention | Elevation Scale (ES) | 1.63 units on a scale | Standard Deviation 1.12 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moral Elevation Intervention | Change From Baseline in Posttraumatic Checklist for DSM-5 (PCL-5) | Baseline | 61.27 Scores on a Scale | Standard Deviation 8.54 |
| Moral Elevation Intervention | Change From Baseline in Posttraumatic Checklist for DSM-5 (PCL-5) | Follow-up | 43.56 Scores on a Scale | Standard Deviation 16.37 |
| No Intervention | Change From Baseline in Posttraumatic Checklist for DSM-5 (PCL-5) | Baseline | 52.34 Scores on a Scale | Standard Deviation 11.4 |
| No Intervention | Change From Baseline in Posttraumatic Checklist for DSM-5 (PCL-5) | Follow-up | 43.30 Scores on a Scale | Standard Deviation 17.05 |
Comparison: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.p-value: <0.00195% CI: [1, 2.49]t-test, 2 sided
Comparison: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.p-value: 0.00295% CI: [0.35, 1.38]t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moral Elevation Intervention | Changes From Baseline in Expression of Moral Injury Scale-Military Version (EMIS-M) | Baseline | 53.93 Scores on a Scale | Standard Deviation 17.43 |
| Moral Elevation Intervention | 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 |
| No Intervention | Changes From Baseline in Expression of Moral Injury Scale-Military Version (EMIS-M) | Baseline | 57.40 Scores on a Scale | Standard Deviation 13.29 |
| No Intervention | Changes From Baseline in Expression of Moral Injury Scale-Military Version (EMIS-M) | Follow-up | 53.75 Scores on a Scale | Standard Deviation 13.43 |
Comparison: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.p-value: 0.95795% CI: [-0.45, 0.91]t-test, 2 sided
Comparison: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.p-value: 0.03395% CI: [0.08, 1.25]t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moral Elevation Intervention | Changes From Baseline in Prosocialness Scale (PS) - Self-report | Baseline | 53.60 Scores on a Scale | Standard Deviation 12.79 |
| Moral Elevation Intervention | Changes From Baseline in Prosocialness Scale (PS) - Self-report | Follow-up | 52.33 Scores on a Scale | Standard Deviation 15.93 |
| No Intervention | Changes From Baseline in Prosocialness Scale (PS) - Self-report | Baseline | 52.95 Scores on a Scale | Standard Deviation 13.98 |
| No Intervention | Changes From Baseline in Prosocialness Scale (PS) - Self-report | Follow-up | 53.00 Scores on a Scale | Standard Deviation 13.4 |
Comparison: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.p-value: 0.76895% CI: [-0.45, 0.71]t-test, 2 sided
Comparison: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.p-value: 0.97595% CI: [-0.53, 0.42]t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
| Moral Elevation Intervention | 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 |
| No Intervention | Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) | Environmental Domain: Follow-up | 59.69 Scores on a scale | Standard Deviation 18.3 |
| No Intervention | Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) | Physical Domain: Baseline | 41.43 Scores on a scale | Standard Deviation 21.03 |
| No Intervention | Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) | Social Domain: Baseline | 43.42 Scores on a scale | Standard Deviation 21.62 |
| No Intervention | Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) | Physical Domain: Follow-up | 41.61 Scores on a scale | Standard Deviation 17.96 |
| No Intervention | Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) | Environmental Domain: Baseline | 60.03 Scores on a scale | Standard Deviation 18.99 |
| No Intervention | Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) | Psychological Domain: Baseline | 35.63 Scores on a scale | Standard Deviation 19.14 |
| No Intervention | Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) | Social Domain: Follow-up | 42.98 Scores on a scale | Standard Deviation 21.56 |
| No Intervention | Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF) | Psychological Domain: Follow-up | 37.92 Scores on a scale | Standard Deviation 20.89 |
Comparison: Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.p-value: 0.01595% CI: [0.32, 1.31]t-test, 2 sided
Comparison: Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.p-value: 0.01295% CI: [0.26, 1.55]t-test, 2 sided
Comparison: Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.p-value: 0.94195% CI: [-0.43, 0.55]t-test, 2 sided
Comparison: Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.p-value: 0.2795% CI: [-0.17, 0.79]t-test, 2 sided