Posttraumatic Stress Disorder Clinical Trial
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03384706 -
A Comparison of CPT Versus ART Versus WL
|
N/A | |
| Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
| Completed |
NCT03129204 -
Sensation Awareness Focused Training for Spouses
|
N/A | |
| Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
| Completed |
NCT05113277 -
Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention
|
N/A | |
| Recruiting |
NCT05327504 -
Written Exposure Therapy for Veterans With SUD and PTSD
|
N/A | |
| Recruiting |
NCT05843695 -
Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
|
N/A | |
| Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
| Completed |
NCT00644423 -
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
|
N/A | |
| Completed |
NCT02989987 -
NET for SGBV Survivors in Eastern DR Congo
|
N/A | |
| Completed |
NCT02320799 -
Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya
|
N/A | |
| Recruiting |
NCT02293291 -
Thermal Clinic Treatment in Gulf War Illness
|
Phase 1/Phase 2 | |
| Completed |
NCT02242136 -
Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants
|
N/A | |
| Completed |
NCT02720497 -
The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD
|
N/A | |
| Completed |
NCT01911585 -
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
|
N/A | |
| Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
| Completed |
NCT01693978 -
Contingency Outcomes in Prolonged Exposure
|
N/A | |
| Completed |
NCT01469754 -
Longitudinal Survey Analysis in Lymphoma Survivors
|
N/A | |
| Completed |
NCT02362477 -
Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD
|
Phase 3 | |
| Terminated |
NCT01239173 -
Emotional Memory Reactivation in Posttraumatic Stress Disorder
|
Phase 3 |