Posttraumatic Stress DisorderNCT03906240
Pilot Study Testing a Web-Based Moral Elevation Intervention for Veterans With PTSD and Moral Injury
A study testing Moral Elevation intervention in people with Posttraumatic Stress Disorder and Moral Injury, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Moral Injury
- What is being tested?
- Moral Elevation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- Veteran Participant Exclusion Criteria:
- History of severe traumatic brain injury indicated by medical review and the Ohio State Traumatic Brain Injury Identification Method (OSU TBI-ID)
- Psychosis or current substance use disorder indicated by medical review and the Mini International Neuropsychiatric Interview (MINI)
- Current suicide risk based on the Beck Depression Inventory-II (BDI-II)
- Significant Other Participant Exclusion Criteria:
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, 76504
About this study
Official title: Using Moral Elevation to Improve Functioning in Veterans With PTSD and Moral Injury: A Pilot Study of a Web-Based Intervention
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder, Moral Injury
- Being tested
- Moral Elevation intervention
- Keywords
- Web-Based Intervention, Pilot Study, Moral Elevation, Veterans, PTSD, Moral Injury
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moral Elevation interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Moral Elevation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start2 Mar 2020
- Primary completion30 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Adam P. McGuire, PhD, Principal investigator, Central Texas Veterans Health Care System, Temple, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906240
- Sponsor's protocol ID
- D3035-P
- Status last verified
- Jun 2024
- First submitted
- 27 Mar 2019
- Last updated
- 13 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
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.
PubMed 39207432
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Moral Elevation to Improve Functioning in Veterans With PTSD and Moral Injury: A Pilot Study of a Web-Based Intervention
- ClinicalTrials.gov ID
- NCT03906240
- Acronym / sponsor ID
- D3035-P
- Conditions
- Posttraumatic Stress Disorder, Moral Injury
- Keywords
- Web-Based Intervention, Pilot Study, Moral Elevation, Veterans, PTSD, Moral Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Posted 13 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Moral Elevation interventionMoral Elevation Intervention (described in intervention section). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (6 listed)
- History of severe traumatic brain injury indicated by medical review and the Ohio State Traumatic Brain Injury Identification Method (OSU TBI-ID)
- Psychosis or current substance use disorder indicated by medical review and the Mini International Neuropsychiatric Interview (MINI)
- Current suicide risk based on the Beck Depression Inventory-II (BDI-II)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moral Elevation interventionThe 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. | Behavioural | Moral Elevation Intervention |
Primary outcome
Treatment Evaluation Inventory-Short Form (TEI-SF)
Time frame: 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)
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.
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.
1 secondary outcome
Elevation Scale (ES)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39207432McGuire 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.
- Individual participant dataSharing planned: Yes. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam P. McGuire, PhD principal investigator
Central Texas Veterans Health Care System, Temple, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moral Elevation intervention in people with Posttraumatic Stress Disorder and Moral Injury, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Evaluation Inventory-Short Form (TEI-SF) (time frame: Follow-up assessment within 1 week of study completion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.