Improving Mind/Body Health and Functioning With Integrative Exercise
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|ClinicalTrials.gov Identifier: NCT02856412|
Recruitment Status : Recruiting
First Posted : August 4, 2016
Last Update Posted : November 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic||Other: Veterans Group Exercise (VGX) Other: Illness Management and Recovery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Mind/Body Health and Functioning With Integrative Exercise|
|Actual Study Start Date :||September 4, 2017|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: Veterans Group Exercise
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.
Other: Veterans Group Exercise (VGX)
Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.
Other Name: VGX, Exercise Classes
Active Comparator: Illness Management and Recovery
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.
Other: Illness Management and Recovery
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.
Other Name: IMR, Health Education Classes, PTSD Recovery Classes
- Clinician Administered PTSD Scale (CAPS) score comparison between subjects randomized to Integrative Exercise Treatment vs. Illness Management and Recovery [ Time Frame: 12 weeks ]The CAPS-5 is a 30 item scale that provides both a dimensional and categorical measure of PTSD. The CAPS-5 items are rated with a single severity score that incorporates both frequency and intensity PTSD-related symptoms. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization).
- The World Health Organization Quality of Life (WHOQOL-BREF) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only [ Time Frame: 12 weeks ]The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original WHOQOL-100 instrument and is more convenient for use in large research studies or clinical trials. The Psychological Domain, the investigators' primary outcome, is derived from 6 items which index body image, negative & positive feelings, self-esteem, spirituality, and cognition. Each item has 5 response options with higher scores denoting higher psychological health. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make transformed domain scores to a range of 4-20 comparable with the scores used in the WHOQOL-100.
- Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 12 weeks ]The FFMQ is a 39-item questionnaire derived from a factor analysis of other mindfulness questionnaires. It assesses five facets of mindfulness: observing, describing, acting with awareness, non-judging and non-reactivity to inner experience which represent elements of mindfulness as it is currently conceptualized. Items are rated on a Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true).
- The Physical Activity Self-Efficacy scale (PASE) [ Time Frame: 12 weeks ]The PASE will be used as an exploratory measure of perceived confidence to continue exercising in the face of competing day-to-day conditions.
- Godin Leisure-Time Exercise Questionnaire [ Time Frame: 12 weeks ]The Godin Leisure-Time Exercise Questionnaire is a validated brief inventory assessing sedentary, work, recreational, and aerobic activity in a typical week.
- PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 12 weeks ]The PCL-5 is a validated self-report rating scale for assessing PTSD symptoms. It consists of 20 items that correspond to the DSM-5 symptoms of PTSD.
- Symptom Check-List-90-Revised (SCL-90-R) [ Time Frame: 12 weeks ]The SCL-90-R is a standard self-report measure of general psychopathology.
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 12 weeks ]This self-report measure provides a subjective assessment of sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances (including nightmares), use of sedative-hypnotics, and daytime energy.
- PSQI- PTSD Addendum (PSQI-A) [ Time Frame: 12 weeks ]The PSQI-A assesses disruptive nocturnal behaviors related to PTSD, such as hot flashes, nightmares, and episodes of terror during sleep.
- Insomnia Severity Index (ISI) [ Time Frame: 12 weeks ]The ISI is a self-report measure that is a more specific index of perceived insomnia severity, as compared to the widely used PSQI measure which captures sleep disturbances of all types.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856412
|Contact: Thomas C Neylan, MD||(415) 750-6961||Thomas.Neylan@va.gov|
|Contact: Jennifer A Hlavin, MS||(415) 221-4810 ext firstname.lastname@example.org|
|United States, California|
|San Francisco VA Medical Center, San Francisco, CA||Recruiting|
|San Francisco, California, United States, 94121|
|Contact: Walter M Holleran, PharmD 415-221-4810 ext 2118 Walter.Holleran@va.gov|
|Contact: Rebecca Yu (415) 221-4810 ext 3687 email@example.com|
|Principal Investigator: Thomas C. Neylan, MD|
|Principal Investigator:||Thomas C. Neylan, MD||San Francisco VA Medical Center, San Francisco, CA|