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

NCT ID: NCT01975857

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2019-02-28

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.

Conditions

Sleep Disturbance; Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mind-Body Bridging Program

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.

Group Type: EXPERIMENTAL

Mind-Body Bridging Program

Intervention Type: BEHAVIORAL

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

Supportive Education

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

Group Type: ACTIVE_COMPARATOR

Supportive Education

Intervention Type: BEHAVIORAL

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

Interventions

Mind-Body Bridging Program

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

Intervention Type: BEHAVIORAL

Supportive Education

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

Intervention Type: BEHAVIORAL

Other Intervention Names

MBB; SED

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Salt Lake City Health Care System

FED

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Yoshio Nakamura

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoshio Nakamura, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Pain Research Center

Salt Lake City, Utah, United States

VA Salt Lake City Heath Care System

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

IRB00061854

Identifier Type: -

Identifier Source: org_study_id