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

250 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment MOVED for PTSD?

The research on the Warrior Wellness study suggests that exercise, a component of MOVED, can improve PTSD symptoms in older veterans. Additionally, the MOVE! program, which is similar to MOVED, has shown effectiveness in weight management among veterans with PTSD, indicating potential benefits for overall health and well-being. ^{1 2 3 4 5}

Is the MOVED treatment for PTSD safe for humans?

The available research does not provide specific safety data for the MOVED treatment for PTSD or any other conditions. However, studies emphasize the importance of assessing adverse events (unwanted effects) in mental health treatments, suggesting that safety monitoring is crucial in clinical trials. ^{6 7 8 9 10}

What is the purpose of this trial?

Despite the availability of evidence-based treatments for PTSD, there are many challenges to successful trauma recovery for Veterans including difficulties starting and completing these treatments and gaps in fully addressing additional important treatment targets including lower social functioning and quality of life. Alternative, stand-alone treatment options that address a range of outcomes and can be easily accessed are needed to expand the reach of PTSD treatment to Veterans. One way to address this need is with a positive psychology intervention called MOVED, which has shown promise in a prior pilot study. MOVED is a web-based, self-guided intervention (8 sessions, 4 weeks) that uses moral elevation-feeling inspired by others' virtuous actions. This clinical trial will test if MOVED leads to decreased PTSD symptoms and increased social functioning and quality of life compared to a generic supportive treatment that does not focus on moral elevation. Results will help determine if MOVED is a useful alternative approach to target trauma recovery among Veterans with PTSD.

Research Team

Adam P. McGuire, PhD

Principal Investigator

Central Texas Veterans Health Care System, Temple, TX

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and clinical benefit of a trauma-focused stabilisation group for post-traumatic stress disorder patients with complex presentations on primary care waitlists. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Factors associated with PTSD symptom improvement among Iraq and Afghanistan veterans receiving evidenced-based psychotherapy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A SMART approach to optimizing delivery of an mHealth intervention among cancer survivors with posttraumatic stress symptoms. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Weight loss after participation in a national VA weight management program among veterans with or without PTSD. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Exploring the experience of boarded psychiatric patients in adult emergency departments. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. [2023]

10. Netherlands 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. [2023]