Mind-Body Rehabilitative Program for Veterans With mTBI (Mild Traumatic Brain Injury)

NCT01975857 | Completed

• 1 other identifier: IRB00061854
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

The broad aim of the proposed study is to evaluate the comprehensive benefit of a novel mind-body therapeutic intervention, Mind-Body Bridging (MBB), in Veterans who suffer from mTBI and sleep disturbance co-morbid with PTSD and/or pain at the VA Salt Lake City Health Care System (VASLCHCS). Evidence for comprehensive benefit includes, but is not limited to, the average difference in outcomes between MBB and an active control, sleep education (SED), both integrated with the usual care for mTBI Veterans. The long-term goal of the proposed project is to introduce, implement and establish mind-body intervention programs as a behavioral health intervention modality that would serve as a generally sustainable health care intervention program before, during, and after deployment for military personnel.

Conditions

Sleep Disturbance; Traumatic Brain Injury

Keywords

mild traumatic brain injury; sleep; mind body intervention; mind body bridging

Outcome Measures

Primary Outcomes (8)

• Change in self-reported measures of sleep using Medical Outcomes Study -Sleep Scale, from baseline (Pre) to 6 months follow-up

  The Medical Outcomes Study Sleep Scale (MOS-SS) provides an index of sleep problems and incorporates six sleep scale scores: 1) sleep disturbance, 2) sleep adequacy, 3) daytime somnolence, 4) snoring, 5) waking up short of breath with a headache, and 6) quantity of sleep. The MOS-SS is similar to the Pittsburgh Sleep Quality Index (PSQI) developed at the same time, which includes more questions about sleep disturbance with seven more items overall. The 1-week assessment is adapted from the normal 4-week retrospective assessment.

  Pre (within one month before Intervention week 1), Intervention week 1, Intervention week 2, Intervention week 3, Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up

• Change in latency to sleep onset using the Sleep Diary, from baseline (Pre) to 6 months follow-up.

  The Sleep Diary is a commonly used self-reported sleep assessment measure. Participants will be asked to complete a sleep diary for seven days. In the sleep diary, participants will record different daily events and activities (e.g., the number of times they wake up during the night, whether they have been drinking caffeinated beverages, or exercising). Sleep-related entries include recording when they go to bed, when they think they fell asleep, duration of sleep, and naps during the day.

  Pre (within one month before Intervention week 1), Intervention week 2, Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up

• Change in self-reported mTBI symptoms using the Neurobehavioral Symptom Inventory (NSI), from baseline (Pre) to 6 months follow-up.

  The NSI is a self-report measure of post-concussive symptoms comprising 22-items. Participants rate the degree of symptom severity on a five-point scale ranging from 0 (none) to 4 (very severe) over the past 2 weeks. The NSI total score is the sum of severity ratings of the 22 symptoms, and ranges from 0 to 88. The NSI reflects a 9 symptom cluster model, which can be validly reduced to 3 clusters, namely, cognitive, affective, and somatic/sensory symptoms.

  Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up

• Change in self-reported Quality of Life using the Medical Outcomes Study (MOS) Short Form-36 (SF-36) for Veterans (MOS SF-36V), from baseline (Pre) to 6 months follow-up.

  The MOS SF-36V is a well-established standard measure of quality of life (QOL) scale, to assess mental and physical health as well as functional status, adapted for Veterans. The MOS SF-36V consists of the same eight sections as the civilian version, MOS SF-36. Higher scores indicate better quality of life. The instrument provides a global score, as well as the following subscale scores: functional capacity, physical aspects, pain, general health condition, vitality, social aspects and emotional aspects, and mental health.

  Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up

• Change in duration of sleep using the Sleep Diary, from baseline (Pre) to 6 months follow-up.

  The Sleep Diary is a commonly used self-reported sleep assessment measure. Participants will be asked to complete a sleep diary for seven days. In the sleep diary, participants will record different daily events and activities (e.g., the number of times they wake up during the night, whether they have been drinking caffeinated beverages, or exercising). Sleep-related entries include recording when they go to bed, when they think they fell asleep, duration of sleep, and naps during the day.

  Pre (within one month before Intervention week 1), Intervention week 2, Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up

• Change in number of awakenings using the Sleep Diary, from baseline (Pre) to 6 months follow-up.

  The Sleep Diary is a commonly used self-reported sleep assessment measure. Participants will be asked to complete a sleep diary for seven days. In the sleep diary, participants will record different daily events and activities (e.g., the number of times they wake up during the night, whether they have been drinking caffeinated beverages, or exercising). Sleep-related entries include recording when they go to bed, when they think they fell asleep, duration of sleep, and naps during the day.

  Pre (within one month before Intervention week 1), Intervention week 2, Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up

• Change in physical activity during sleep for assessment of sleep quality using a heart rate and motion detection device, from baseline (Pre) to 3 months follow-up

  The non-invasive heart rate and motion detection device will be used to quantify physical activity during sleep for assessment of sleep quality as a measure of sleep disturbance. Each participant will be asked to wear the device for 2 consecutive days of home assessment.

  Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up

• Change in heart rate variability for assessment of sleep quality using a heart rate and motion detection device, from baseline (Pre) to 3 months follow-up

  The non-invasive heart rate and motion detection device will be used to quantify heart rate variability for assessment of sleep quality as a measure of sleep disturbance. Each participant will be asked to wear the device for 2 consecutive days of home assessment.

  Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up

Secondary Outcomes (16)

• Change in self-reported PTSD using the PTSD Checklist - Military Version (PCL-M), from baseline (Pre) to 6 months follow-up.

  Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up

• Change in self-reported pain symptoms using the Brief Pain Inventory (BPI), from baseline (Pre) to 6 months follow-up.

  Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up

• Change in self-reported depression symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D), from baseline (Pre) to 6 months follow-up.

  Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up

• Change in self-reported resilience using the Connor-Davidson Resilience Scale (CD-RISC), from baseline (Pre) to 6 months follow-up.

  Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up

• Change in self-reported perceived stress symptoms using the Perceived Stress Scale (PSS), from baseline (Pre) to 6 months follow-up.

  Pre (within one month before Intervention week 1), InterventionWeek1, InterventionWeek2, InterventionWeek3, Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up

Study Arms (2)

Mind-Body Bridging Program

EXPERIMENTAL

The Mind-Body Bridging Program (MBBP) is an awareness training program (ATP) to help individuals improve their health condition and attain a state of well-being. Bridging is the primary technique that facilitates the healing process, by bringing one back to the present moment to experience thoughts, emotions and physical sensations. Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.

Behavioral: Mind-Body Bridging Program

Supportive Education

ACTIVE COMPARATOR

Supportive Education program will provide educational lectures on disability, sleep hygiene, and current research on depression and non-directive, supportive discussions about these topics.

Behavioral: Supportive Education

Interventions

Mind-Body Bridging Program BEHAVIORAL

Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.

Also known as: MBB

Mind-Body Bridging Program

Supportive Education BEHAVIORAL

This intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics.

Also known as: SED

Supportive Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran from OEF/OIF
• has been diagnosed with mTBI
• has current sleep disturbance as indicated by a score of 35 or greater on the MOS-Sleep Scale (MOS-SS)

You may not qualify if:

• serious psychiatric comorbidity
• active intense suicidal intent
• inpatient admission to psychiatric ward in the last 3 month
• the presence of co-occurring progressive/advanced neurodegenerative disease
• terminally ill
• unstable chronic medical conditions
• untreated sleep apnea
• presence of substance dependence disorder
• narcolepsy
• frequent nocturia
• delayed sleep phase syndrome
• advanced sleep phase syndrome

Sponsors & Collaborators

• University of Utah: lead
• VA Salt Lake City Health Care System: collaborator

Study Sites (2)

Pain Research Center

Salt Lake City, Utah, 84108, United States

Location

VA Salt Lake City Heath Care System

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Parasomnias; Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Yoshio Nakamura, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: November 5, 2013
• Study Start: October 1, 2013
• Primary Completion: February 28, 2018
• Study Completion: February 1, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Locations

US (2)