- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07541820
Tailored Yoga Therapy for Attention-deficit Hyperactivity Disorder (Yoga4ADHD)
Tailored Yoga Therapy for Attention-deficit Hyperactivity Disorder in Adults: A Feasibility Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary aim of the study is to test the feasibility and acceptability of a tailored, group-based yoga intervention for adults with attention-deficit hyperactivity disorder, by monitoring recruitment, engagement, and completion rates, and through obtaining qualitative feedback from participants at the end of the intervention.
A secondary aim is to explore whether the yoga intervention is associated with improvements in attention-deficit hyperactivity disorder and related symptoms (i.e., anxiety, depression), quality of life, and general functioning, compared to a control intervention (group-based functional movement sessions). The secondary outcomes will be assessed with self-report questionnaires at the start, middle and end of the yoga and control interventions, and three months after completion of the interventions.
The investigators will also examine aspects of cognitive and physiological functioning through laboratory testing at the start and end of the intervention, focusing on measures of autonomic activation (e.g., the 'fight or flight response), bodily awareness, attention, and response inhibition. Physiological functioning, such as sleep quality, activity levels, and heart rate, will be monitored throughout the six-week study with wearable devices (e.g., Fitbit activity trackers), to provide longer-term, real-world insights into the possible benefits of the intervention.
The investigators will explore whether the yoga intervention is associated with improvements in attention-deficit hyperactivity disorder and related symptoms/abilities, including emotional regulation, social behaviour, attention, focus, interoception and stress reactivity. The investigators will also explore whether the yoga intervention is linked with improved bodily stress markers (heart rate variability), sleep, and physical activity.
This feasibility randomised controlled trial will include 20 participants who will be randomly allocated (1:1) to either the group-based tailored yoga therapy intervention (n=10), or a group-based functional movement class (n=10). The latter will be a structured class focusing on light strength, mobility and flexibility.
All participants will attend an initial in-person laboratory testing session at the start and end of the 6-week intervention. Each week, both intervention group and control group will attend an in-person one-hour group session. Each week, participants will be asked to practice at least twice, using a 20-minute video recording on demand from home. Outcomes will be measured using self-report, lab-based, and digital wearable measures.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom
- King's College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Are aged 18 or older.
- Score above the clinical cut-off threshold on the Adult Attention-Deficit Hyperactivity Disorder (ADHD) Self-Report Scale.
- Are fluent in English.
- Have normal or corrected eyesight.
Exclusion Criteria:
- Major physical health disorders or disabilities that may affect participation (e.g., uncontrolled epilepsy, significant mobility challenges).
- Major mental health disorders that may affect participation (e.g., active psychosis, severe alcohol/substance use disorder).
- Current recipient of any other mind-body therapy for attention-deficit hyperactivity disorder.
- Current participation in a regular yoga activity.
- Current pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Tailored yoga
A 6-week group-based yoga programme designed for people experiencing attention-deficit hyperactivity disorder symptoms.
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Participants in this arm will participate in a six-week study. They will attend one hour-long group-based in-person session per week, as well as practising from home at least twice weekly following along an online video (which will be a practice of what was learnt in-person that week). Each group yoga session will start with some Pranayama (yogic breathwork) to engage participants' attention and to help them focus. The intervention will progress from purely activating yogic breathwork techniques, to some calming and grounding techniques to aid relaxation, bodily awareness and to reduce stress. Sessions will also involve some faster movements to align the body with typically faster mental activities as seen within individuals with ADHD. Some sessions may progress to include some mindful somatic movements and some longer held poses to enhance relaxation and tension release. Towards the end of the intervention there will be longer opportunities for mindful awareness through meditation. |
|
Other: Functional movement
Participants will receive an active control of functional movement.
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Participants in this arm will similarly participate in a six-week study. They will attend one hour-long group-based in-person session per week, as well as practising from home at least twice weekly following along an online video (which will be a practice of what was learnt in-person that week). The functional movement control sessions will serve as an exercise class, with educational aspects. All sessions will follow a similar structure of light strength exercises, mobility exercises and end with some flexibility exercises. This control condition was selected to control for the physical aspects the yoga intervention, allowing us to isolate the possible benefits of yoga due to breathwork and mindfulness. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility outcomes.
Time Frame: From enrolment to the 3-month follow-up.
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The investigators will monitor recruitment, engagement and completion rates to assess feasibility, and will obtain qualitative participant feedback at the end of the intervention.
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From enrolment to the 3-month follow-up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Exploratory assessment of self-reported change in attention-deficit hyperactivity disorder.
Time Frame: From enrolment to the 3-month follow-up.
|
The outcomes will be assessed with self-report questionnaires at the start, middle and end of the yoga and control interventions, and 3-months after completion of the intervention.
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From enrolment to the 3-month follow-up.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in self-reported general health symptoms.
Time Frame: From enrolment to the 3-month follow-up.
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The investigators will assess anxiety levels (Generalized Anxiety Disorder - 7), interoceptive awareness (Multidimensional Assessment of Interoceptive Awareness), health (Patient Health Questionnaire - 8), quality of life (36-item Short Form survey), and social functioning (Work & Social Adjustment Scale).
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From enrolment to the 3-month follow-up.
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Laboratory-based assessments to test changes in autonomic arousal.
Time Frame: Baseline to post-intervention.
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The investigators will examine aspects of physiological functioning through laboratory testing at the start and end of the intervention, focusing on measures of autonomic activation (e.g., the 'fight or flight response), through electrocardiogram and skin conductance.
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Baseline to post-intervention.
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Laboratory-based assessments to test changes in executive functioning attention.
Time Frame: Baseline to post-intervention.
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The investigators will test attention through The Sustained Attention Task.
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Baseline to post-intervention.
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Laboratory-based assessments to test changes in executive functioning inhibition control.
Time Frame: Baseline to post-intervention.
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The investigators will test response inhibition through the Stop Signal Task.
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Baseline to post-intervention.
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Wearable-derived measures of physiological functioning.
Time Frame: From enrolment to the 3-month follow-up.
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Physiological functioning will be monitored throughout the six-week study and follow-up period with wearable devices (Fitbit Inspire 3 activity tracker watches).
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From enrolment to the 3-month follow-up.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susannah Pick, PhD, King's College London
Publications and helpful links
General Publications
- Weaver LL, Darragh AR. Systematic Review of Yoga Interventions for Anxiety Reduction Among Children and Adolescents. Am J Occup Ther. 2015 Nov-Dec;69(6):6906180070p1-9. doi: 10.5014/ajot.2015.020115.
- Cohen SCL, Harvey DJ, Shields RH, Shields GS, Rashedi RN, Tancredi DJ, Angkustsiri K, Hansen RL, Schweitzer JB. Effects of Yoga on Attention, Impulsivity, and Hyperactivity in Preschool-Aged Children with Attention-Deficit Hyperactivity Disorder Symptoms. J Dev Behav Pediatr. 2018 Apr;39(3):200-209. doi: 10.1097/DBP.0000000000000552.
- Fincham GW, Strauss C, Montero-Marin J, Cavanagh K. Effect of breathwork on stress and mental health: A meta-analysis of randomised-controlled trials. Sci Rep. 2023 Jan 9;13(1):432. doi: 10.1038/s41598-022-27247-y.
- Siebieszuk A, Plonski AF, Baranowski M. Breathwork for Chronic Stress and Mental Health: Does Choosing a Specific Technique Matter? Med Sci (Basel). 2025 Aug 13;13(3):127. doi: 10.3390/medsci13030127.
- Yildiz S, Grinstead J, Hildebrand A, Oshinski J, Rooney WD, Lim MM, Oken B. Immediate impact of yogic breathing on pulsatile cerebrospinal fluid dynamics. Sci Rep. 2022 Jun 28;12(1):10894. doi: 10.1038/s41598-022-15034-8.
- Wilens TE, Biederman J, Faraone SV, Martelon M, Westerberg D, Spencer TJ. Presenting ADHD symptoms, subtypes, and comorbid disorders in clinically referred adults with ADHD. J Clin Psychiatry. 2009 Nov;70(11):1557-62. doi: 10.4088/JCP.08m04785pur.
- Shiels K, Hawk LW Jr. Self-regulation in ADHD: the role of error processing. Clin Psychol Rev. 2010 Dec;30(8):951-61. doi: 10.1016/j.cpr.2010.06.010. Epub 2010 Jun 28.
- Shanker S, Pradhan B. Effect of yoga on children with autism spectrum disorder in special schools. Ind Psychiatry J. 2022 Jul-Dec;31(2):367-369. doi: 10.4103/ipj.ipj_212_21. Epub 2022 Aug 30.
- Sengupta P. Health Impacts of Yoga and Pranayama: A State-of-the-Art Review. Int J Prev Med. 2012 Jul;3(7):444-58.
- Rubia K. Cognitive Neuroscience of Attention Deficit Hyperactivity Disorder (ADHD) and Its Clinical Translation. Front Hum Neurosci. 2018 Mar 29;12:100. doi: 10.3389/fnhum.2018.00100. eCollection 2018.
- Rafi H, Murray R, Delavari F, Perroud N, Vuilleumier P, Debbane M, Piguet C. Neural Basis of Internal Attention in Adults with Pure and Comorbid ADHD. J Atten Disord. 2023 Feb;27(4):423-436. doi: 10.1177/10870547221147546. Epub 2023 Jan 12.
- Martin J. Why are females less likely to be diagnosed with ADHD in childhood than males? Lancet Psychiatry. 2024 Apr;11(4):303-310. doi: 10.1016/S2215-0366(24)00010-5. Epub 2024 Feb 7.
- Malhotra V, Javed D, Wakode S, Bharshankar R, Soni N, Porter PK. Study of immediate neurological and autonomic changes during kapalbhati pranayama in yoga practitioners. J Family Med Prim Care. 2022 Feb;11(2):720-727. doi: 10.4103/jfmpc.jfmpc_1662_21. Epub 2022 Feb 16.
- Hariprasad VR, Arasappa R, Varambally S, Srinath S, Gangadhar BN. Feasibility and efficacy of yoga as an add-on intervention in attention deficit-hyperactivity disorder: An exploratory study. Indian J Psychiatry. 2013 Jul;55(Suppl 3):S379-84. doi: 10.4103/0019-5545.116317.
- Gunaseelan L, Vanama MS, Abdi F, Qureshi A, Siddiqua A, Hamid MA. Yoga for the Management of Attention-Deficit/Hyperactivity Disorder. Cureus. 2021 Dec 16;13(12):e20466. doi: 10.7759/cureus.20466. eCollection 2021 Dec.
- Fritz K, O'Connor PJ. Effects of a 6 Week Yoga Intervention on Executive Functioning in Women Screening Positive for Adult ADHD: A Pilot Study. Front Sports Act Living. 2022 Feb 24;4:746409. doi: 10.3389/fspor.2022.746409. eCollection 2022.
- Faheem M, Akram W, Akram H, Khan MA, Siddiqui FA, Majeed I. Gender-based differences in prevalence and effects of ADHD in adults: A systematic review. Asian J Psychiatr. 2022 Sep;75:103205. doi: 10.1016/j.ajp.2022.103205. Epub 2022 Jul 14.
- Cheshire A, Richards R, Cartwright T. 'Joining a group was inspiring': a qualitative study of service users' experiences of yoga on social prescription. BMC Complement Med Ther. 2022 Mar 14;22(1):67. doi: 10.1186/s12906-022-03514-3.
- Cascade E, Kalali AH, Wigal SB. Real-World Data on: Attention Deficit Hyperactivity Disorder Medication Side Effects. Psychiatry (Edgmont). 2010 Apr;7(4):13-5.
- Brown RP, Gerbarg PL, Muench F. Breathing practices for treatment of psychiatric and stress-related medical conditions. Psychiatr Clin North Am. 2013 Mar;36(1):121-40. doi: 10.1016/j.psc.2013.01.001.
- Birdee G, Nelson K, Wallston K, Nian H, Diedrich A, Paranjape S, Abraham R, Gamboa A. Slow breathing for reducing stress: The effect of extending exhale. Complement Ther Med. 2023 May;73:102937. doi: 10.1016/j.ctim.2023.102937. Epub 2023 Mar 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR-25/26-53625
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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