Exercise for Adolescent Anxiety
(BRAINS Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wayne State University
Must not be taking: Cannabis, Oral contraceptives
Disqualifiers: Neurological, Psychotic, Bipolar, Diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must stop using cannabis or cannabinoid products for at least 4 weeks before joining the study.
What data supports the effectiveness of this treatment for adolescent anxiety?
Research shows that regular physical activity, including moderate and aerobic exercise, is linked to lower levels of anxiety and depression in adolescents. Studies indicate that engaging in moderate to high levels of physical activity can significantly reduce the risk of anxiety and depressive symptoms.12345
Is exercise safe for adolescents with anxiety?
How is moderate intensity exercise different from other treatments for adolescent anxiety?
Eligibility Criteria
This trial is for adolescents who may be experiencing anxiety, as it explores how exercise can impact fear regulation. Specific eligibility criteria are not provided, but typically participants would need to be in good health and able to perform moderate intensity exercise.Inclusion Criteria
I am between 14 and 17 years old.
Right-handed
Availability of a parent or legal guardian who is willing to provide consent and attend all study visits
See 4 more
Exclusion Criteria
Currently pregnant, lactating, or positive pregnancy test at screening visit
I have been using oral contraceptives in the past 6 weeks.
I have ongoing symptoms from a traumatic brain injury.
See 15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo either moderate intensity exercise or a sedentary control condition to assess fear regulation and endocannabinoid signaling
3 days
Daily visits for 3 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 week
Treatment Details
Interventions
- Moderate Intensity Exercise (Behavioural Intervention)
Trial OverviewThe study investigates whether moderate intensity exercise can improve the ability of adolescents to regulate fear by enhancing brain activity and endocannabinoid signaling, which could lead to better treatments for anxiety.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Moderate Intensity ExerciseExperimental Treatment1 Intervention
Group II: Control (Coloring)Active Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tolan Park Medical BuildingDetroit, MI
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Who Is Running the Clinical Trial?
Wayne State UniversityLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
A meta-analysis on the anxiety-reducing effects of acute and chronic exercise. Outcomes and mechanisms. [2022]The relationship between exercise and anxiety has been extensively examined over the last 15 years. Three separate meta-analysis were conducted to quantitatively review the exercise-anxiety literature for state anxiety, trait anxiety and psychophysiological correlates of anxiety. Such a procedure allows tendencies of the research to be characterised. The results substantiate the claim that exercise is associated with reductions in anxiety, but only for aerobic forms of exercise. These effects were generally independent of both subject (i.e. age and health status) and descriptive characteristics. Numerous design characteristics were different, but these differences were not uniform across the 3 meta-analyses. For state anxiety, exercise was associated with reduced anxiety, but had effects similar to other known anxiety-reducing treatments (e.g. relaxation). The trait anxiety meta-analysis revealed that random assignment was important for achieving larger effects when compared to the use of intact groups. Training programmes also need to exceed 10 weeks before significant changes in trait anxiety occur. For psychophysiological correlates, cardiovascular measures of anxiety (e.g. blood pressure, heart rate) yielded significantly smaller effects than did other measures (e.g. EMG, EEG). The only variable that was significant across all 3 meta-analyses was exercise duration. Exercise of at least 21 minutes seems necessary to achieve reductions in state and trait anxiety, but there were variables confounding this relationship. As such, it remains to be seen what the minimum duration is necessary for anxiety reduction. Although exercise offers therapeutic benefits for reducing anxiety without the dangers or costs of drug therapy or psychotherapy, it remains to be determined precisely why exercise is associated with reductions in anxiety. Since several mechanisms may be operating simultaneously, future research should be designed with the idea of testing interactions between these mechanisms.
The effects of aerobic exercise on childhood PTSD, anxiety, and depression. [2019]The purpose of the present study was to investigate the effects of aerobic exercise on childhood PTSD, depression, and anxiety. Fifteen participants, ages 14 to 17, who met DSM-IV Criteria for PTSD were recruited from an all female residential treatment center Participants engaged in an aerobic exercise program for 40 minutes, three times per week, for a total of 8 weeks. Measures included were the Children's PTSD Inventory, the UCLA Post-Traumatic Stress Disorder Reaction Index for DSM-IV, Children's Depression Inventory, and the Revised Children's Manifest Anxiety Scale. Measures were administered twice at pre-intervention, again at mid-intervention, post-intervention, and at a one-month follow-up. This small n study utilized a staggered baseline, pre/post repeated measures design. Results of this study provided support for the positive effects of aerobic exercise on reducing PTSD, depression, and anxiety. Fewer participants met full criteria for PTSD after exercising. This research is a starting point toward satisfying the essential need to establish efficacious methods to treat PTSD and associated symptoms in child/adolescent populations.
The effect of physical activity on anxiety in children and young people: a systematic review and meta-analysis. [2021]There is emerging evidence that physical activity can have beneficial effects on anxiety. A comprehensive synthesis of the evidence of the anxiolytic effects of physical activity from randomised controlled trials (RCTs) in children and young people (CYP) is warranted.
Brief report: Associations of physical activity with anxiety and depression symptoms and status among adolescents. [2019]The purpose of this study is to investigate associations between physical activity (PA), depression, and anxiety among adolescents in Ireland. Adolescents (N = 481; 281 male, 200 female) aged 15.1 ± 1.7y self-reported PA level, depression, and anxiety. Approximately 21% of adolescents were high trait anxious, and ∼37% reported scores indicating probable depression. Anxiety and depressive symptoms were higher for low PA (60 min/d, 0-2 d/wk) compared to moderate (60 min/d, 3-4 d/wk) and high (60 min/d, 5-7 d/wk) PA. After adjustment for relevant covariates, reduced odds of depression were 30% and 56% for moderate and high PA, respectively; reduced odds of high trait anxiety were 46% and 47% for moderate and high PA, respectively. These findings support the need for adolescents to engage in moderate PA, with potential for increased benefits with increased PA. To conclude, moderate and high PA are inversely associated with anxiety and depressive symptoms, and risk of depression and high trait anxiety in adolescents.
Relationship among subjective exercise experience, exercise behavior, and trait anxiety in adolescents. [2023]To investigate the influence of subjective exercise experience on adolescent trait anxiety and to reveal the mediating effect of exercise behavior.
Association between different contexts of physical activity and anxiety-induced sleep disturbance among 100,648 Brazilian adolescents: Brazilian school-based health survey. [2021]Physical activity (PA) practice can be a protective factor for anxiety-induced sleep disturbance (AISD), however the association between different contexts of PA and anxiety-induced sleep disturbance is not clear. We aimed to analyze the association between different contexts of PA and AISD. Data from the Brazilian School-based Health Survey [n=100,648; age: 14.3y (range:11-18 years)], conducted in 2015, were used. Higher PA during transport was associated with higher AISD. PA during physical education classes presented lower odds for AISD. PA practiced outside school was associated with reduced AISD among boys. The association between PA and AISD seems to be context-dependent.
An examination of the anxiolytic effects of exercise for people with anxiety and stress-related disorders: A meta-analysis. [2019]The literature regarding exercise for people with established anxiety disorders is equivocal. To address this issue, we conducted a systematic review and meta-analysis investigating the benefits of exercise compared to usual treatment or control conditions in people with an anxiety and/or stress-related disorders. Major electronic databases were searched from inception until December/2015 and a random effect meta-analysis conducted. Altogether, six randomized control trials (RCTs) including 262 adults (exercise n=132, 34.74 [9.6] years; control n=130, 37.34 [10.0] years) were included. Exercise significantly decreased anxiety symptoms more than control conditions, with a moderate effect size (Standardized Mean Difference=-0.582, 95%CI -1.0 to -0.76, p=0.02). Our data suggest that exercise is effective in improving anxiety symptoms in people with a current diagnosis of anxiety and/ or stress-related disorders. Taken together with the wider benefits of exercise on wellbeing and cardiovascular health, these findings reinforce exercise as an important treatment option in people with anxiety/stress disorders.
Evaluation of a brief aerobic exercise intervention for high anxiety sensitivity. [2022]Anxiety sensitivity, or the belief that anxiety-related sensations can have negative consequences, has been shown to play an important role in the etiology and maintenance of panic disorder and other anxiety-related pathology. Aerobic exercise involves exposure to physiological cues similar to those experienced during anxiety reactions. The present study sought to investigate the efficacy of a brief aerobic exercise intervention for high anxiety sensitivity. Accordingly, 24 participants with high anxiety sensitivity scores (Anxiety Sensitivity Index-Revised scores >28) were randomly assigned to complete either six 20-minute sessions of aerobic exercise or a no-exercise control condition. The results indicated that individuals assigned to the aerobic exercise condition reported significantly less anxiety sensitivity subsequent to exercise, whereas anxiety sensitivity scores among non-exercisers did not significantly change. The clinical research and public health implications of these findings are discussed, and several potential directions for additional research are recommended.
Working out the worries: A randomized controlled trial of high intensity interval training in generalized anxiety disorder. [2021]Aerobic exercise (AE) demonstrated an overall medium treatment effect in anxiety disorders (AD) but there is evidence for an "intensity-response" relationship. High intensity interval training (HIIT) was highly effective on a range of (mental) health parameters. However, so far no randomised-controlled trial (RCT) investigated the efficacy of HIIT in AD.
Dimensions of Physical Activity Are Important in Managing Anxiety in Older Adults: A Systematic Review and Meta-Analysis. [2023]Physical activity (PA) is a known approach for managing anxiety symptoms in older adults. This systematic review and meta-analysis address the benefits of PA and its dimensions (frequency, session time, type, and intervention period) on anxiety symptoms in older adults aged 65 years and above. Searches covered eight databases reporting eight randomized controlled trials (RCTs) and five non-RCTs. Meta-analysis of RCTs (standardized mean difference = -0.41; 95% confidence interval [-0.58, -0.24]; p