Combination Therapies + Lifestyle Modifications for Traumatic Brain Injury
(CoINTEGRATE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Must not be taking: Steroids
Disqualifiers: Severe depression, Substance abuse, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests if combining talking therapy, brain exercises, and lifestyle changes can help people with neurocognitive disorders live better lives by improving their thinking, brain function, and daily habits.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on intravenous or oral steroids for MS, you may not be eligible to participate.
What data supports the effectiveness of the treatment Combination Therapies + Lifestyle Modifications for Traumatic Brain Injury?
Research suggests that cognitive rehabilitation and behavioral health interventions, including Cognitive Behavioral Therapy (CBT) and lifestyle modifications, can help manage symptoms in individuals with traumatic brain injury (TBI). These approaches have shown promise in improving emotional distress and promoting healthy lifestyle changes, which are important for recovery.
12345Is the combination of therapies and lifestyle modifications safe for people with traumatic brain injury?
The studies reviewed suggest that cognitive and lifestyle interventions, such as cognitive behavioral therapy and healthy lifestyle programs, are generally safe for people with traumatic brain injury. Participants in these programs reported positive experiences, and no significant safety concerns were noted.
12456How is the treatment of combination therapies and lifestyle modifications for traumatic brain injury different from other treatments?
This treatment is unique because it combines multiple therapies, such as Cognitive Behavioral Therapy (CBT) and Cognitive Rehabilitation Therapy (CRT), with lifestyle changes to address the complex nature of traumatic brain injury (TBI), rather than focusing on a single therapy. This approach aims to target different aspects of TBI simultaneously, potentially leading to better outcomes than using one therapy alone.
378910Eligibility Criteria
This trial is for adults over 50 with mild cognitive impairment (MCI) or those aged 21-65 with traumatic brain injury (TBI), multiple sclerosis (MS), or long COVID, experiencing certain levels of cognitive decline. They must be part of the Michigan medicine network and able to consent. Excluded are individuals with severe depression, suicidal thoughts, other major neurological conditions, recent MS relapse, diagnosed sleep disorders, sensory impairments, substance abuse issues, or currently in similar therapies.Inclusion Criteria
I have been diagnosed with TBI, MS, Long COVID, or MCI.
I am over 50 with MCI or between 21-65 with another diagnosis and am treated within the Michigan medicine network.
Participants that can provide consent or legally authorized representative who can provide consent on their behalf
+1 more
Exclusion Criteria
My cognitive abilities are within normal range for my age and education.
I have had mild cognitive impairment for over a year.
I experience symptoms like headache or dizziness from a brain injury.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive comprehensive multimodal individually tailored Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle sessions
9 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The CoINTEGRATE study tests a tailored mix of Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and lifestyle changes against usual care to see if it improves life quality and community integration for people with neurocognitive disorders resulting from TBI or MS.
2Treatment groups
Experimental Treatment
Active Control
Group I: CRT plus CBT and Lifestyle modificationsExperimental Treatment3 Interventions
Group II: Usual careActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
References
Predictors of Intervention Adherence in Compensatory Cognitive Training for Veterans With a History of Mild Traumatic Brain Injury. [2021]The purpose of this study was to determine modifiable predictors of intervention adherence in a study of group-based Compensatory Cognitive Training (CCT) for Iraq/Afghanistan War veterans with a history of mild traumatic brain injury (mTBI).
Treatment of Psychiatric Problems After Traumatic Brain Injury. [2022]Psychiatric sequelae of traumatic brain injury (TBI) can cause significant and often chronic impairment in functioning and quality of life; however, their phenomenological and mechanistic complexities continue to present significant treatment challenges. The clinical presentation is often an amalgam of syndromes and co-occurring symptoms that require a highly nuanced and systematic approach to treatment. Although few randomized controlled trials have tested treatments for psychiatric problems after TBI and the synthesis of results continues to be compromised by the heterogeneity of study populations, small samples, and differing inclusion criteria and outcome measures, an increasing body of literature supports evidence-based treatment strategies. We provide a narrative review of pharmacological, psychoeducational/behavioral, and neuromodulation treatments for psychiatric conditions in adults with TBI and discuss known or postulated mechanisms of action for these treatment approaches. Where data are available, we focus on randomized controlled trials and large case series in which a psychiatric condition provides both a selection criterion and a primary or secondary outcome. We conclude by proposing directions for future research, particularly the need for novel neuropharmacological, behavioral, and neurophysiological studies and pragmatic trials of multicomponent and adaptive models that will increase understanding of the mechanisms underlying post-TBI psychiatric disorders and accelerate dissemination and implementation of effective person-centered care.
Treatment of persistent post-concussive symptoms after mild traumatic brain injury: a systematic review of cognitive rehabilitation and behavioral health interventions in military service members and veterans. [2018]Increased prevalence of traumatic brain injury (TBI) has been associated with service members and veterans who completed combat deployments in support of Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF). Management of persistent post-concussive symptoms (PCS) has been a challenge to healthcare providers throughout the Military and Veterans Healthcare Systems, as well as civilian healthcare providers, due in part to the chronic nature of symptoms, co-occurrence of behavioral health disorders such as depression, Posttraumatic Stress Disorder (PTSD), and substance use disorders, and fear of a potential stigma associated with psychiatric diagnoses and behavioral health treatment(s). This systematic review examined non-pharmacologic behavioral health interventions and cognitive rehabilitation interventions for PCS in military service members and veterans with a history of mild TBI (mTBI). Six electronic databases were searched with specific term limitations, identifying 121 citations. Ultimately, 19 articles met criteria for inclusion in this systematic review. Studies were broadly categorized into four subtypes: psychoeducational interventions, cognitive rehabilitation, psychotherapeutic approaches, and integrated behavioral health interventions for PCS and PTSD. The review provides an update of the empirical evidence for these four types of interventions for PCS in active duty service members and veterans. Recommendations for future research are discussed, including the need to expand and improve the limited evidence basis on how to manage persistent post-concussive symptoms in this population.
The efficacy of cognitive behavior therapy in the treatment of emotional distress after acquired brain injury. [2018]To evaluate the efficacy of cognitive behavior therapy (CBT), adapted to meet the unique needs of individuals with acquired brain injury (ABI), and modified for both group and telephone delivery.
Evaluation of a 12-month lifestyle intervention by individuals with traumatic brain injury. [2020]Weight gain and inactivity are common problems for individuals living with a traumatic brain injury (TBI). Yet, interventions to support a healthy lifestyle specific to individuals with TBI are lacking. The purpose of this study was to complete a program evaluation of a 12-month evidence-based healthy lifestyle intervention adapted for people with a TBI. Eighteen participants completed a brief interview after the yearlong intervention to determine their perceptions of the program effectiveness as well as barriers and facilitators in making lifestyle changes. Participants reported staff, tracking of dietary and activity behavior, and in-person meetings as most helpful aspects. Lack of motivation and difficulty preparing healthy meals were the primary barriers to a healthy lifestyle. Qualitative data revealed five themes that influenced healthy behaviors, including (1) self-regulation, (2) environmental resources, (3) knowledge of health behaviors, (4) TBI-related impairment and comorbidities, and (5) social support. Results suggest that future iterations of the healthy lifestyle intervention should emphasize self-regulation activities; require tracking of dietary and activity behaviors across 12 months; provide concurrent support for individual motivation issues; provide prepared meals; utilize web-based, telephonic, or hybrid approaches to delivery; further simplify the curriculum and learning tools; and include caregivers and peer accountability partners. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
Brain Injury: How Dietary Patterns Impact Long-Term Outcomes. [2023]Individuals with a history of traumatic brain injury (TBI) are at a much greater risk for developing cardiovascular disease (CVD) compared to the general population. This review discusses dietary patterns as a means of addressing modifiable risk factors following TBI exposure. Evidence-based resources for practicing Physiatrists and Brain Injury Medicine specialists pertaining to nutrition education and counseling are also provided.
Mindfulness-based cognitive therapy: benefits in reducing depression following a traumatic brain injury. [2022]Current therapies for traumatic brain injury (TBI) include pharmacotherapy, psychotherapy, and cognitive rehabilitation. Unfortunately, psychological and emotional issues regularly go untreated in individuals with TBI even after they receive treatment for physical, behavioral, and cognitive issues. Mindfulness-based cognitive therapy (MBCT) may offer new rehabilitation opportunities for individuals with TBI.
Combination therapies for traumatic brain injury: prospective considerations. [2022]Traumatic brain injury (TBI) initiates a cascade of numerous pathophysiological events that evolve over time.Despite the complexity of TBI, research aimed at therapy development has almost exclusively focused on single therapies, all of which have failed in multicenter clinical trials. Therefore, in February 2008 the National Institute of Neurological Disorders and Stroke, with support from the National Institute of Child Health and Development, the National Heart, Lung, and Blood Institute, and the Department of Veterans Affairs, convened a workshop to discuss the opportunities and challenges of testing combination therapies for TBI. Workshop participants included clinicians and scientists from a variety of disciplines, institutions, and agencies. The objectives of the workshop were to: (1) identify the most promising combinations of therapies for TBI; (2) identify challenges of testing combination therapies in clinical and pre-clinical studies; and (3) propose research methodologies and study designs to overcome these challenges. Several promising combination therapies were discussed, but no one combination was identified as being the most promising. Rather, the general recommendation was to combine agents with complementary targets and effects (e.g., mechanisms and time-points), rather than focusing on a single target with multiple agents. In addition, it was recommended that clinical management guidelines be carefully considered when designing pre-clinical studies for therapeutic development.To overcome the challenges of testing combination therapies it was recommended that statisticians and the U.S. Food and Drug Administration be included in early discussions of experimental design. Furthermore, it was agreed that an efficient and validated screening platform for candidate therapeutics, sensitive and clinically relevant biomarkers and outcome measures, and standardization and data sharing across centers would greatly facilitate the development of successful combination therapies for TBI. Overall there was great enthusiasm for working collaboratively to act on these recommendations.
Combination therapies for neurobehavioral and cognitive recovery after experimental traumatic brain injury: Is more better? [2019]Traumatic brain injury (TBI) is a significant health care crisis that affects two million individuals in the United Sates alone and over ten million worldwide each year. While numerous monotherapies have been evaluated and shown to be beneficial at the bench, similar results have not translated to the clinic. One reason for the lack of successful translation may be due to the fact that TBI is a heterogeneous disease that affects multiple mechanisms, thus requiring a therapeutic approach that can act on complementary, rather than single, targets. Hence, the use of combination therapies (i.e., polytherapy) has emerged as a viable approach. Stringent criteria, such as verification of each individual treatment plus the combination, a focus on behavioral outcome, and post-injury vs. pre-injury treatments, were employed to determine which studies were appropriate for review. The selection process resulted in 37 papers that fit the specifications. The review, which is the first to comprehensively assess the effects of combination therapies on behavioral outcomes after TBI, encompasses five broad categories (inflammation, oxidative stress, neurotransmitter dysregulation, neurotrophins, and stem cells, with and without rehabilitative therapies). Overall, the findings suggest that combination therapies can be more beneficial than monotherapies as indicated by 46% of the studies exhibiting an additive or synergistic positive effect versus on 19% reporting a negative interaction. These encouraging findings serve as an impetus for continued combination studies after TBI and ultimately for the development of successful clinically relevant therapies.
Complementary and alternative interventions for fatigue management after traumatic brain injury: a systematic review. [2020]We systematically reviewed randomized controlled trials (RCTs) of complementary and alternative interventions for fatigue after traumatic brain injury (TBI).