MOVED for PTSD

Overseen By Adam P McGuire, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Severe TBI, Psychosis, Mania, Suicide risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new online treatment, called MOVED, for Veterans with PTSD. The researchers aim to determine if MOVED can reduce PTSD symptoms and improve social life and well-being by using moral elevation (feeling inspired by others' good actions). Participants will either try MOVED or a generic supportive care program. Veterans who have had PTSD for at least a year, are enrolled in VISN 17, and have internet access might be a good fit.

As an unphased trial, this study offers Veterans the opportunity to contribute to innovative research that could enhance PTSD treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot be actively participating in certain trauma-focused treatments.

What prior data suggests that the MOVED intervention is safe for Veterans with PTSD?

Research has shown that the MOVED program has potential as a treatment for PTSD. Although earlier studies were smaller, they found no major safety concerns. As an online, self-guided program, MOVED is generally considered low-risk. It aims to boost positive feelings by highlighting the good deeds of others, which can help improve mood and social interactions. Reports have indicated no negative effects with this type of program, making it a well-accepted option for those seeking alternative PTSD treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MOVED treatment for PTSD because it offers a fresh approach compared to traditional options like psychotherapy and medication. Unlike standard therapies, MOVED is an online intervention specifically designed to evoke moral elevation, which may help veterans experiencing distress by fostering positive emotions and a sense of connectedness. This digital delivery method makes it accessible and convenient, potentially reaching more individuals in need.

What evidence suggests that MOVED might be an effective treatment for PTSD?

Research has shown that the MOVED program, tested in this trial, might help Veterans with PTSD by encouraging feelings of inspiration from observing others perform good deeds. Early results from a small study suggested that Veterans using MOVED felt more positive about their emotions and themselves. This indicates that MOVED could help reduce PTSD symptoms and improve social interactions and overall quality of life. While online treatments for PTSD usually offer only small benefits, the focus on inspiration in MOVED is unique and promising. Participants in this trial may receive either the MOVED intervention or a supportive care control, which is a present-centered, nondirective intervention. ^{6 7 8 9 10}

Who Is on the Research Team?

Adam P. McGuire, PhD

Principal Investigator

Central Texas Veterans Health Care System, Temple, TX

Are You a Good Fit for This Trial?

This trial is for veterans with PTSD who are looking for alternative treatment options. Participants should be open to web-based, self-guided sessions focusing on positive psychology. Specific eligibility criteria were not provided, so interested individuals should inquire further.

Inclusion Criteria

Enrolled in a VISN 17 health care system

Willingness to complete study procedures and be randomized

Internet access and an electronic device to complete the web-based sessions

Exclusion Criteria

Current psychosis or mania as indicated by medical record review and the Mini International Neuropsychiatric Interview (MINI)

Current suicide risk based on the Beck Depression Inventory-II (BDI-II)

I am currently in a trauma-focused therapy like CPT, PE, or EMDR.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a web-based, self-guided intervention (MOVED) or supportive care control for 8 sessions over 4 weeks

4 weeks

8 sessions (web-based)

Follow-up

Participants are monitored for PTSD symptoms, social functioning, and quality of life at posttreatment, 3-month, and 6-month follow-ups

6 months

3 follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• MOVED

Trial Overview

The MOVED program, a web-based intervention that promotes feelings of moral elevation through inspiring content over 8 sessions in 4 weeks, is being tested against a generic supportive care control to see if it can reduce PTSD symptoms and improve social functioning and quality of life.

How Is the Trial Designed?

Group I: MOVED Experimental Treatment 1 Intervention

Moral Elevation Online Intervention for Veterans Experiencing Distress.

Group II: Supportive Care Control Active Control 1 Intervention

Present-centered, nondirective intervention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

The Mental Health Trigger Tool (MHTT) was developed to effectively identify adverse events (AEs) and mental health-related patient safety incidents (MHPSIs) in mental health settings, demonstrating a high sensitivity of 98.6% and perfect specificity of 100% based on a review of 515 patient records.

Using the MHTT, researchers found AEs in 19% and MHPSIs in 11% of patient records, indicating its practical utility in enhancing patient safety monitoring in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. Sajith, SG., Fung, DSS., Chua, HC.[2023]

The study is evaluating the effectiveness of the Cancer Distress Coach mobile app versus usual care in 400 hematopoietic stem cell transplantation survivors experiencing PTSD symptoms, aiming to improve their quality of life.

Using a novel stepped-care SMART design, the trial will adapt treatment based on individual responses, potentially leading to more personalized and effective PTSD interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A SMART approach to optimizing delivery of an mHealth intervention among cancer survivors with posttraumatic stress symptoms. Smith, SK., Somers, TJ., Kuhn, E., et al.[2023]

Veterans with PTSD participating in the MOVE! weight management program lost significantly less weight compared to those without mental health diagnoses, indicating a need for tailored approaches for this group.

Overall, veterans with other mental health conditions also experienced less weight loss than those without, suggesting that the MOVE! program may require adaptations to better support veterans facing mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss after participation in a national VA weight management program among veterans with or without PTSD. Hoerster, KD., Lai, Z., Goodrich, DE., et al.[2019]

Women veterans and those who started evidence-based psychotherapy (EBP) within a year of seeking mental health care had higher chances of improving their PTSD symptoms, indicating the importance of timely intervention.

Completing at least 8 sessions of EBP and receiving specific therapies like Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT) individually were linked to better outcomes, suggesting that both the timing and type of treatment can significantly influence recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with PTSD symptom improvement among Iraq and Afghanistan veterans receiving evidenced-based psychotherapy. Maguen, S., Holder, N., Li, Y., et al.[2021]

The Warrior Wellness pilot study aims to assess the feasibility and effectiveness of a 12-week exercise program for older veterans (aged 60 and above) with PTSD, focusing on improving PTSD symptoms and cardiovascular endurance.

This study will provide insights into how regular exercise can impact the health of older veterans with PTSD, potentially leading to better treatment options and improved quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD. Hall, KS., Morey, MC., Beckham, JC., et al.[2020]

A systematic review of 115 psychotherapy study protocols revealed that while 77 protocols explicitly addressed harm, there was a lack of standardization in how harm was conceptualized and assessed, particularly regarding adverse events.

The review highlighted that although serious adverse events were defined consistently, the definitions and considerations for adverse events varied widely, suggesting a need for more standardized approaches in clinical research to effectively monitor and report harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

In a study of 200 psychiatric patients boarded in emergency departments, those who experienced adverse events (AEs) had a significantly longer average boarding time of 35 hours compared to 6.5 hours for those without AEs, indicating that longer stays may increase the risk of negative outcomes.

The research highlights that both the length of time patients spend in the emergency department and the duration of boarding after admission are critical factors that elevate the likelihood of experiencing adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the experience of boarded psychiatric patients in adult emergency departments. Major, D., Rittenbach, K., MacMaster, F., et al.[2021]

This study will analyze adverse events in psychotherapy for youth with OCD by including at least 128 participants aged 8-17, comparing family-based cognitive behavioral therapy (FCBT) and family-based psychoeducation and relaxation training (FPRT).

The mixed methods approach will combine quantitative assessments of adverse events with qualitative interviews to better understand their nature and causes, aiming to improve the safety and effectiveness of psychotherapy for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. Pretzmann, L., Christensen, SH., Bryde Christensen, A., et al.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11869835/

Adapting MOVED as a web-based moral elevation ...

In this paper, we outline the process and final adaptations decisions in preparation for a future efficacy trial to assess the impact of MOVED ...

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clinicaltrials.gov

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A Randomized Controlled Trial of a Web-Based Moral ...

Results will help determine if MOVED is a useful alternative approach to target trauma recovery among Veterans with PTSD. Detailed Description.

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formative.jmir.org

formative.jmir.org/2023/1/e39894

Moral Elevation Online Intervention for Veterans Experiencing ...

This study aimed to examine the feasibility and acceptability of a novel, web-based moral elevation intervention for veterans with PTSD symptoms and moral ...

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hsrd.research.va.gov

hsrd.research.va.gov/publications/esp/Resources-for-PTSD.pdf

Internet and Mobile Interventions for Adults with PTSD and ...

▻ Internet and mobile interventions may have small to negligible benefits on posttraumatic stress disorder (PTSD) and depression outcomes for military Veterans ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39207432/

Preliminary results from a moral elevation intervention pilot ...

Results: Veterans in the MOVED condition reported more positive rumination than the control condition for both emotion-focus (b = 2.70, p = .023) and self-focus ...

6.

who.int

who.int/news-room/fact-sheets/detail/post-traumatic-stress-disorder

Post-traumatic stress disorder

WHO fact sheet on post-traumatic stress disorder, including key facts, symptoms, treatments, self-care and WHO response.

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research.va.gov

research.va.gov/topics/ptsd.cfm

Posttraumatic Stress Disorder (PTSD)

Veterans with PTSD are more likely to be unemployed than those without the disorder. The model begins with in-depth interviews to explore individual Veterans' ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4168808/

Posttraumatic Stress Disorder in Adults: Impact ...

The paper provides a concise review of the evolution of PTSD diagnosis in the Diagnostic and Statistical Manual of Mental Disorders, impact of PTSD in the ...

9.

mayoclinic.org

mayoclinic.org/diseases-conditions/post-traumatic-stress-disorder/symptoms-causes/syc-20355967

Post-traumatic stress disorder (PTSD) - Symptoms and ...

Symptoms may include flashbacks, nightmares, severe anxiety and uncontrollable thoughts about the event.

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psychiatry.org

psychiatry.org/patients-families/ptsd/what-is-ptsd

What is Posttraumatic Stress Disorder (PTSD)?

PTSD is a psychiatric condition that may occur in people who have experienced or witnessed a traumatic event or series of traumatic events.