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

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Traumatic Brain Injury; Sleep Disturbance

Treatments: Behavioral: Supportive Education; Behavioral: Mind-Body Bridging Program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01975857

IRB00061854

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Mind-Body Bridging Program

Experimental group

Description:

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.

Treatment:

Behavioral: Mind-Body Bridging Program

Supportive Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Supportive Education