Telehealth Delivered Exercise Promotion for Depression After TBI
Recruiting in Palo Alto (17 mi)
Overseen byCharles Bombardier, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
Disqualifiers: Bipolar, Schizophrenia, Substance use, others
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
The purpose of this randomized controlled trial is to evaluate whether the InMotion intervention, delivered via telehealth (using a HIPAA-compliant video platform or phone), which uses evidence-based behavioral and motivational counseling to increase daily physical activity, is an effective treatment for Major Depressive Disorder (MDD) for people who are at least one year out from sustaining a traumatic brain injury (TBI). The first aim is to compare the efficacy of the InMotion intervention to the waitlist control (WLC) condition on measures of depression severity and associated conditions in under-active adults with TBI and MDD. For the second aim the investigators plan to identify possible moderators of exercise treatment effects. The third aim will examine possible mediators of treatment outcome. In addition, the weekly dose of exercise, the extent to which exercise generates positive affect, and engagement in enjoyable or meaningful aspects of life will be explored.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on an unstable dose of standard depression treatment, you will need to be on a stable regimen for at least 3 weeks before participating.
What data supports the effectiveness of the treatment InMotion, Telehealth Delivered Exercise Promotion, Exercise-Based Treatment for Major Depression after TBI?
Research shows that exercise programs, including those delivered via telehealth, can improve mood and mental health in people with traumatic brain injury (TBI). Studies have found that exercise can lead to small improvements in depression and anxiety symptoms, suggesting that similar exercise-based treatments may help with depression after TBI.12345
Is telehealth delivered exercise promotion safe for humans?
How does the InMotion treatment for depression after TBI differ from other treatments?
Eligibility Criteria
This trial is for adults aged 18-64 who have had a traumatic brain injury (TBI) over a year ago, are diagnosed with Major Depressive Disorder, lead a sedentary lifestyle, and are medically cleared to exercise. They must be able to consent, have internet access at home, and not be drug-dependent or planning surgery.Inclusion Criteria
Over-enrollment of people who identify as African American to address higher risk of depression and barriers to treatment
Enrollment in the Traumatic Brain Injury Model System (TBIMS) from one of the six referring centers
Deemed medically safe to exercise (based on the Physical Activity Readiness Questionnaire (PAR-Q+) modified; if a yes response to any question, physician attestation required)
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Exclusion Criteria
I am awaiting surgery or my depression medication dose is changing.
Drug dependence as defined within the Mini International Neuropsychiatric Interview (MINI)
I do not have severe psychiatric conditions or active suicidal thoughts.
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the InMotion intervention, a telehealth-delivered exercise promotion program, for 12 weeks
12 weeks
8 counseling sessions (telehealth)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Treatment Details
Interventions
- InMotion (Behavioural Intervention)
Trial OverviewThe InMotion program aims to treat depression in people with TBI through motivational counseling and physical activity via telehealth. Participants will either receive the intervention immediately or be placed on a waitlist control group to compare outcomes.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: InMotion Intervention ConditionActive Control1 Intervention
The intervention consists of a manualized physical activity counseling program and includes motivational interviewing over a HIPAA-compliant telehealth delivery model. There will be 8 counseling sessions over 12 weeks. Sessions will be 30-90 minutes long and scheduled during weeks 1-4, 6, 8, 10, and 12. The Fitbit Charge 5 will be set up to sync with the participants' internet-connected device to share activity data with the physical activity coach /interventionist to monitor progress and tailor treatment goals.
Given the InMotion intervention was designed to treat Major Depressive Disorder (MDD) in Traumatic Brain Injury (TBI), the intervention will be delivered by a mental health provider (licensed masters level social worker/MSW) with training and supervision in behavioral aspects of exercise promotion and supervised by a psychologist (who is also the study Principal Investigator) and a physical therapist.
Group II: Wait List Control (WLC) ConditionPlacebo Group1 Intervention
The WLC control condition entails following usual care and includes the ability to participate in the intervention at the 12 week-end point for the intervention group. The WLC condition is based on equity considerations; the investigators want all participants to have access to treatment. Equity is especially important given our plans to over-enroll African American persons given statistically increased barriers to access care.
InMotion is already approved in United States for the following indications:
🇺🇸 Approved in United States as InMotion for:
- Major Depressive Disorder (MDD) in individuals with Traumatic Brain Injury (TBI)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Washington Medical CenterSeattle, WA
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
National Institute on Disability, Independent Living, and Rehabilitation ResearchCollaborator
References
The effects of exercise to promote quality of life in individuals with traumatic brain injuries: a systematic review. [2021]To systematically review the effects of exercise interventions that may enhance quality of life (QOL) in individuals with traumatic brain injury (TBI).
Physical activity: perceptions of people with severe traumatic brain injury living in the community. [2019]Increasing physical activity (PA) among people with severe traumatic brain injury (TBI) represents an important long-term rehabilitation goal. To design effective interventions to promote PA, the factors associated with PA engagement post-TBI need to be understood.
Remotely Supervised Exercise Programmes to Improve Balance, Mobility, and Activity Among People with Moderate to Severe Traumatic Brain Injury: Description and Feasibility. [2023]Further investigation into the feasibility of using videoconferencing and activity tracking devices to provide high-intensity home-based exercise programmes for people with a moderate or severe traumatic brain injury (TBI) is needed to inform clinical implementation and patient adoption. This study aimed to (1) determine if home-based telerehabilitation exercise programmes were feasible for people with a moderate or severe TBI and (2) better understand the lived experience of people with a TBI and their family partners with this programme.
A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. [2021]Objective: To assess the feasibility of conducting an aerobic exercise training study in a community setting for individuals with traumatic brain injury (TBI)Methods: This is a prospective, randomized, and controlled study. Nine participants (three moderate-to-severe and six mild TBI) were randomized to a community-based 3-month individualized aerobic exercise training program (AET). Seven participants (four moderate-to-severe, three mild TBI) were randomized to a stretching and toning program (SAT). Cardiorespiratory fitness (CRF) level was assessed with peak oxygen uptake (VO2peak) testing.Results: After 3 months of training, the AET trended toward improved VO2peak when compared with the SAT group (8% vs - 4%, p = .059) with a large effect size of 1.27. Only 50% of participants in the AET group completed more than 70% of the assigned exercise sessions. No adverse events were reported. Both the AET and SAT groups reported small improvements in self-reported mood symptoms, including depression, anxiety, and anger.Conclusions: It is feasible to conduct an exercise training study and improve CRF for persons with TBI in community settings with structured exercise protocols. However, exploring methods to enhance adherence is crucial for future exercise clinical trials to improve brain health in this population.
Benefits of exercise maintenance after traumatic brain injury. [2012]To examine the effect of exercise intervention on exercise maintenance, depression, quality of life, and mental health at 6 months for people with traumatic brain injury (TBI) with at least mild depression.
Pilot randomized controlled trial of exercise training for older veterans with PTSD. [2021]Exercise training positively impacts mental health, yet remains untested in older adults with posttraumatic stress disorder (PTSD). We conducted a randomized controlled pilot trial to test the feasibility and acceptability of exercise training in older veterans with PTSD. Fifty-four veterans ≥ 60 years, with a DSM-V diagnosis of PTSD, were randomized to supervised exercise (n = 36) or wait-list (WL; n = 18). Primary outcomes included recruitment rates, attendance, satisfaction, and retention. Secondary outcomes included changes in PTSD symptoms, depression, health-related quality of life, and sleep quality; assessed at baseline and 12 weeks. There were no adverse events. Attrition was minimal (14%), and adherence to the exercise intervention was high (82%). Clinically significant improvements in PTSD and related conditions were observed following exercise (Cohen's d = 0.36-0.81). Exercise training is safe and acceptable in older adults with PTSD, may improve PTSD symptoms, and broadly impacts PTSD-related conditions. Future definitive trials are warranted.
The efficacy of exercise interventions for all types of inpatients across mental health settings: A systematic review and meta-analysis of 47 studies. [2023]This systematic review and meta-analysis investigated the benefits, safety and adherence of exercise interventions delivered in inpatient mental health settings, quantified the number of exercise trials that provided support to maintain engagement in exercise post-discharge, and reported patient feedback towards exercise interventions. Major databases were searched from inception to 22.06.2022 for intervention studies investigating exercise in mental health inpatient settings. Study quality was assessed using Cochrane and ROBINS-1 checklists. Fifty-six papers were included from 47 trials (including 34 RCTs), bias was high. Exercise improved depression (Standardised mean difference = -0.416; 95% Confidence interval -0.787 to -0.045, N = 15) compared to non-exercise comparators amongst people with a range of mental illnesses, with further (albeit limited) evidence suggesting a role of exercise in cardiorespiratory fitness and various other physical health parameters and ameliorating psychiatric symptoms. No serious exercise-related adverse events were noted, attendance was ≥80% in most trials, and exercise was perceived as enjoyable and useful. Five trials offered patients post-discharge support to continue exercise, with varying success. In conclusion, exercise interventions may have therapeutic benefits in inpatient mental health settings. More high-quality trials are needed to determine optimal parameters, and future research should investigate systems to support patients to maintain exercise engagement once discharged.
Attending to Timely Contingencies: Promoting Physical Activity Uptake Among Adults with Serious Mental Illness with an Exercise-For-Mood vs. an Exercise-For-Fitness Prescription. [2022]Despite evidence for both physical and mental health benefits achieved through regular exercise, most Americans fail to meet minimum recommendations. Altering the behavioral contingency from a focus on long-term health benefits to immediate mood benefits represents a novel method for exercise promotion. The current study examined a single-session exercise-for-mood intervention against two time-matched comparison conditions in 152 patients with serious mental illness attending a partial hospital program, a population marked by significant health disparities. This intervention was compared to a standard exercise-for-fitness intervention and a time-matched no-exercise control. Among patients with high levels of exercise prior to the partial hospital program, the exercise-for-mood intervention yielded significant increases in exercise. Implications for exercise promotion interventions among psychiatrically ill patients are discussed.
Exercise for mental illness: a systematic review of inpatient studies. [2018]A substantial body of evidence supports the role of exercise interventions for people with a mental illness. However, much of this literature is conducted using outpatient and community-based populations. We undertook a systematic review examining the effect of exercise interventions on the health of people hospitalized with depression, schizophrenia, bipolar disorder, or anxiety disorders. Eight studies met our inclusion criteria. Several studies show positive health outcomes from short-term and long-term interventions for people hospitalized due to depression. Although positive, the evidence for inpatients with schizophrenia, bipolar disorder, or anxiety disorders is substantially less. There is an urgent need to address the paucity of literature in this area, in particular the optimal dose and delivery of exercise for people hospitalized as a result of mental illness. Standardization of reporting exercise programme variables, the assessment of mental illness, and the reporting of adverse events must accompany future studies.
[Enjoying Sports and Movement in Mental Illness]. [2022]Enjoying Sports and Movement in Mental Illness Abstract. Sports and exercise therapy is an effective complemant in the treatment of major depression. The recommendations of at least 150 minutes of moderate or 75 minutes of intensive physical activity per week should be met to achieve positive effects of physical activity. In addition, individual needs and the physical health conditions must be considered in the planning and implementation, so that exercise will be enjoyed in the long term.
Participatory co-creation of an adapted physical activity program for adults with moderate-to-severe traumatic brain injury. [2022]Research about using physical activity (PA) to improve health, quality of life, and participation after moderate-to-severe traumatic brain injury (TBI) is receiving growing attention. However, best-practices for maintaining PA participation after TBI have yet to be defined. In this context, a team of researchers and stakeholders with a moderate-to-severe TBI (including program participants and peer mentors) participated in a co-creation process to optimize a 9-month, 3-phased, community-based, adapted PA program named TBI-Health.
Feasibility and effect of aerobic exercise for lowering depressive symptoms among individuals with traumatic brain injury: a pilot study. [2012]: To establish the feasibility and effect of an aerobic exercise intervention on symptoms of depression among individuals with traumatic brain injury.