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Veterans Group Exercise (VGX) for Post-Traumatic Stress Disorder

N/A

Waitlist Available

Led By Thomas C. Neylan, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will help determine if exercise, combining aerobic and strength training with concentration training and mindful breathing techniques, is an effective rehabilitation intervention for combat Veterans with PTSD.

Eligible Conditions

Post-Traumatic Stress Disorder (PTSD)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinician Administered PTSD Scale (CAPS) score comparison between subjects randomized to Integrative Exercise Treatment vs. Illness Management and Recovery

The World Health Organization Quality of Life (WHOQOL-BREF) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only

Secondary outcome measures

Five Facet Mindfulness Questionnaire (FFMQ)

Godin Leisure-Time Exercise Questionnaire

Insomnia Severity Index (ISI)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Veterans Group ExerciseExperimental Treatment1 Intervention

Exercise 3 times weekly (for 12 weeks), with each total workout lasting approximately 60 minutes. Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.

Group II: Illness Management and RecoveryActive Control1 Intervention

Attend 3 health education classes weekly (for 12 weeks), with each class lasting approximately 60 minutes. Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,608 Previous Clinical Trials

3,306,448 Total Patients Enrolled

University of California, San FranciscoOTHER

2,498 Previous Clinical Trials

11,936,264 Total Patients Enrolled

Thomas C. Neylan, MDPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA

3 Previous Clinical Trials

261 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications are needed to participate in this research?

"In order to be considered for this trial, potential participants must have a moral injury diagnosis and lie within the age bracket of 18-75. At present, there are 84 individuals being enrolled in the study."

Answered by AI

Are any individuals aged 55 or over participating in this experiment?

"This clinical trial has a minimum age of enrollment set at 18 years old, while the maximum is 75."

Answered by AI

What are the intended outcomes of this experiment?

"The primary end point of this trial, tracked for a period of 12 weeks, is to compare CAPS scores between patients that receive Integrative Exercise Treatment and Illness Management and Recovery. Secondary objectives involve the evaluation of sleep quality via PSQI, physical activity self-efficacy with PASE, and leisure time exercise habits through Godin Questionnaire."

Answered by AI

Is recruitment for this clinical experiment still accepting volunteers?

"Clinicaltrials.gov suggests that this medical trial is not presently looking for subjects, as the study was initially posted on September 4th 2017 and modified most recently on October 6th 2022. Nonetheless, there are currently 343 other experiments actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Mind/Body Health and Functioning With Integrative Exercise

2017. "Improving Mind/Body Health and Functioning With Integrative Exercise". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02856412.