Clinical trial NCT01975857: Mind-Body Rehabilitative Program for Veterans With mTBI (Mild Traumatic Brain Injury)
Official title: Evaluating a Novel Sleep-focused Mind-body Rehabilitative Program for Veterans With mTBI and Other "Polytrauma" Symptoms: An Randomized Controlled Trial (RCT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Traumatic Brain Injury
Keywords: mild traumatic brain injury
sleep
mind body intervention
mind body bridging
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: VA Salt Lake City Health Care System
First posted: 2013-11-05
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Traumatic brain injury represents a dynamic spectrum of physiologic and cognitive dysfunction that exerts effects at multiple levels of human health. Mild traumatic brain injury (mTBI) is a multi-factorial illness that is an increasingly serious public health issue for military and civilian personnel. The assessment of neurocognitive deficits in mTBI has been suggested to be less conclusive, presumably because of the predominating influence of PTSD and other co-morbid factors. Recent research suggests that psychological factors play a substantial role in TBI-related impairments in self-reported health and cognition function. Furthermore, research has shown that TBI is rarely an isolated finding in military combat settings and that persistent post-concussive symptoms are commonly associated with post-traumatic stress disorder and chronic pain, a constellation of findings that has been termed the "polytrauma clinical triad". Indeed, significant numbers of returning Veterans of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) display the polytrauma clinical triad (PCT) of pain, posttraumatic stress disorder (PTSD), and traumatic brain injury. The proposed project will: 1) elucidate best practices for treating mTBI with co-occurring symptoms (pain, sleep disturbance, PTSD) encompassing cognitive, emotional, and psychological functioning; and 2) address psychosocial aspects of managing pain and co-morbidities associated with mTBI through integrative and complementary and alternative approaches.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in self-reported measures of sleep using Medical Outcomes Study -Sleep Scale, from baseline (Pre) to 6 months follow-up
timeFrame: 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
measure: Change in latency to sleep onset using the Sleep Diary, from baseline (Pre) to 6 months follow-up.
timeFrame: 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
measure: Change in self-reported mTBI symptoms using the Neurobehavioral Symptom Inventory (NSI), from baseline (Pre) to 6 months follow-up.
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
measure: 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.
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
measure: Change in duration of sleep using the Sleep Diary, from baseline (Pre) to 6 months follow-up.
timeFrame: 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
measure: Change in number of awakenings using the Sleep Diary, from baseline (Pre) to 6 months follow-up.
timeFrame: 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
measure: 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
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up
measure: 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
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up
Secondary outcomes:
measure: Change in self-reported PTSD using the PTSD Checklist - Military Version (PCL-M), from baseline (Pre) to 6 months follow-up.
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
measure: Change in self-reported pain symptoms using the Brief Pain Inventory (BPI), from baseline (Pre) to 6 months follow-up.
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
measure: Change in self-reported depression symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D), from baseline (Pre) to 6 months follow-up.
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
measure: Change in self-reported resilience using the Connor-Davidson Resilience Scale (CD-RISC), from baseline (Pre) to 6 months follow-up.
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
measure: Change in self-reported perceived stress symptoms using the Perceived Stress Scale (PSS), from baseline (Pre) to 6 months follow-up.
timeFrame: 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
measure: Change in self-reported self-compassion using the Self-Compassion Scale (SCS), from baseline (Pre) to 6 months follow-up.
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
measure: Change in self-reported mindfulness using the Five Facet Mindfulness Questionnaire (FF-MQ), from baseline (Pre) to 6 months follow-up.
timeFrame: 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
measure: Change in self-reported well-being using the Well-Being Index (WBI), from baseline (Pre) to 6 months follow-up.
timeFrame: 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
measure: Change in self-reported type D (distressed) symptoms using the Type D Scale-14 (TYPE-D), from baseline (Pre) to 6 months follow-up.
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
measure: Change in self-reported suicidal ideation using the Beck Scale for Suicide Ideation (BSI), from baseline (Pre) to 6 months follow-up.
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
measure: Change in self-reported interoceptive awareness using the Multidimensional Assessment of Interoceptive Awareness (MAIA), from baseline (Pre) to 6 months follow-up.
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
measure: Change in sustained attention using the Computerized Cognitive Assessment, from baseline (Pre) to 3 months follow-up
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up
measure: Change in diurnal salivary cortisol levels, from baseline (Pre) to 3 months follow-up
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up
measure: Change in diurnal salivary α-amylase levels, from baseline (Pre) to 3 months follow-up
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up
measure: Change in salivary cortisol awakening response, from baseline (Pre) to 3 months follow-up
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up
measure: Change in salivary α-amylase awakening response, from baseline (Pre) to 3 months follow-up
timeFrame: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Pain Research Center
state: Utah
city: Salt Lake City
country: United States
facility: VA Salt Lake City Heath Care System
state: Utah
Study officials:
affiliation: University of Utah
name: Yoshio Nakamura, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: