Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
36 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-11-11
Study Completion Date
2022-11-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Yoga and mindfulness are considered complementary and alternative healthcare options that involve breathing techniques, relaxation, and bodily postures (yoga only). Research has shown a positive effect of these on depression, quality of life, and other symptoms of psychosis. As an 8-week pilot study, the goal is to offer yoga and/or mindfulness online and to explore the effect on recovery and quality of life for people with psychosis.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Yoga and Mindfulness for Psychological and Physical Wellness
NCT03059095
Psychological Trauma
PTSD
COMPLETED
NA
Mindfulness Intervention and Relapse in Psychosis
NCT04060498
Psychosis
UNKNOWN
NA
Breathing Focused Yoga in Social Anxiety Disorder
NCT02266680
Social Anxiety Disorder
COMPLETED
NA
Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression
NCT04711460
Psychosis
COMPLETED
Mindful Yoga for Older Adults and Caregivers
NCT06095037
Psychological
NOT_YET_RECRUITING
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Psychosis impacts about 3% of Canadians at any given time. People with psychosis can experience a combination of positive (e.g., delusions; hallucinations), negative (e.g., amotivation; reduced social activity), or cognitive symptoms (e.g., poorer memory; executive functioning). Positive symptoms are managed via antipsychotic medication and therapeutic support; cognitive symptoms can be targeted via cognitive remediation therapy. For negative symptoms, especially those idiopathic, there are still no effective care options. Yoga is a complementary and alternative medicine (CAM) encompassing health modalities of Eastern cultures, it involves breathing techniques, relaxation, and bodily postures. Research has shown that yoga can improve levels of depression and quality of life, and even attenuate negative symptoms. Given the extensive health care expenditures and unmet care needs for negative symptoms, there is a growing need to consider CAMs, such as yoga, and accessibility of CAMs via online methods. As a pioneering study, this proposed pilot study aims to explore the effect of an 8-week (i.e., 8 sessions) online yoga program on recovery/outcome, with a focus on negative symptoms, for people with psychosis. The investigators aim to recruit 24 people with psychosis and randomly assign them to either the yoga (n=12) or a mindfulness group (n=12); mindfulness, in essence, is yoga without the physical aspect (i.e., poses). The investigators hypothesize that yoga will improve quality of life and attenuate symptom severity, with a larger effect on negative symptoms, above the effect of mindfulness. A nonclinical sample (n=12) will also be recruited to examine feasibility and for feedback purposes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Psychosis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Clinical and non-clinical participants will be assigned to either a yoga or mindfulness condition.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Clinical
Clinical participants with a primary diagnosis of psychosis or related disorder.
Group Type
EXPERIMENTAL
Yoga
Intervention Type
BEHAVIORAL
8 weeks of online weekly yoga or chair yoga class
Mindfulness
Intervention Type
BEHAVIORAL
8 weeks of online weekly mindfulness class
Non-clinical
Non-clinical participants with no mental health diagnoses.
Group Type
ACTIVE_COMPARATOR
Yoga
Intervention Type
BEHAVIORAL
8 weeks of online weekly yoga or chair yoga class
Mindfulness
Intervention Type
BEHAVIORAL
8 weeks of online weekly mindfulness class
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Yoga
8 weeks of online weekly yoga or chair yoga class
Intervention Type
BEHAVIORAL
Mindfulness
8 weeks of online weekly mindfulness class
Intervention Type
BEHAVIORAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
For clinical participants:
* primary diagnosis of a schizophrenia-spectrum disorder (schizophrenia, schizophreniform, schizoaffective) or related psychotic disorder (delusional, brief psychotic, paraphrenia, bipolar with psychotic features, major-depressive with psychotic features)
* access to protected internet (i.e., home internet plugged or password protected wireless)
* adequate space to do yoga (e.g., at least 2 feet around each side of the yoga mat)
* able to speak and read English
* competent and able to offer voluntary informed consent to participate
For non-clinical participants (healthy controls):
* not diagnosed with or received care for any mental illness
* access to protected internet (i.e., home internet plugged or password protected wireless)
* adequate space to do yoga (e.g., at least 2 feet around each side of the yoga mat)
* able to speak and read English
* competent and able to offer voluntary informed consent to participate
* primary diagnosis of a schizophrenia-spectrum disorder (schizophrenia, schizophreniform, schizoaffective) or related psychotic disorder (delusional, brief psychotic, paraphrenia, bipolar with psychotic features, major-depressive with psychotic features)
* access to protected internet (i.e., home internet plugged or password protected wireless)
* adequate space to do yoga (e.g., at least 2 feet around each side of the yoga mat)
* able to speak and read English
* competent and able to offer voluntary informed consent to participate
For non-clinical participants (healthy controls):
* not diagnosed with or received care for any mental illness
* access to protected internet (i.e., home internet plugged or password protected wireless)
* adequate space to do yoga (e.g., at least 2 feet around each side of the yoga mat)
* able to speak and read English
* competent and able to offer voluntary informed consent to participate
Exclusion Criteria
For clinical participants:
* not clinically stable; that is, major change in primary medication (e.g., switching or stopping antipsychotic) or hospitalisation within the past 4 weeks prior to first contact
* currently with a physical ailment that restricts light movement exercises for yoga or chair yoga
For non-clinical participants (healthy controls):
* have a first-degree relative with psychosis (schizophrenia, schizo-affective, schizophreniform, paraphrenia, brief psychotic, delusional, or bipolar or major depressive disorder with psychotic features)
* had a substance or alcohol abuse/dependence in the past 6 months
* currently with a physical ailment that restricts light movement exercises for yoga or chair yoga
* not clinically stable; that is, major change in primary medication (e.g., switching or stopping antipsychotic) or hospitalisation within the past 4 weeks prior to first contact
* currently with a physical ailment that restricts light movement exercises for yoga or chair yoga
For non-clinical participants (healthy controls):
* have a first-degree relative with psychosis (schizophrenia, schizo-affective, schizophreniform, paraphrenia, brief psychotic, delusional, or bipolar or major depressive disorder with psychotic features)
* had a substance or alcohol abuse/dependence in the past 6 months
* currently with a physical ailment that restricts light movement exercises for yoga or chair yoga
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Royal Ottawa Mental Health Centre
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Bodnar, PhD
Role: PRINCIPAL_INVESTIGATOR
The Royal Ottawa Mental Health Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Royal Ottawa Mental Heatlh Centre
Ottawa, Ontario, Canada
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Canada
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Michael Bodnar, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Andersson G. Internet-Delivered Psychological Treatments. Annu Rev Clin Psychol. 2016;12:157-79. doi: 10.1146/annurev-clinpsy-021815-093006. Epub 2015 Dec 11.
Reference Type
BACKGROUND
Andersson G, Titov N, Dear BF, Rozental A, Carlbring P. Internet-delivered psychological treatments: from innovation to implementation. World Psychiatry. 2019 Feb;18(1):20-28. doi: 10.1002/wps.20610.
Reference Type
BACKGROUND
Aust J, Bradshaw T. Mindfulness interventions for psychosis: a systematic review of the literature. J Psychiatr Ment Health Nurs. 2017 Feb;24(1):69-83. doi: 10.1111/jpm.12357. Epub 2016 Dec 8.
Reference Type
BACKGROUND
Bartels SJ, Clark RE, Peacock WJ, Dums AR, Pratt SI. Medicare and medicaid costs for schizophrenia patients by age cohort compared with costs for depression, dementia, and medically ill patients. Am J Geriatr Psychiatry. 2003 Nov-Dec;11(6):648-57. doi: 10.1176/appi.ajgp.11.6.648.
Reference Type
BACKGROUND
Jayaram N, Varambally S, Behere RV, Venkatasubramanian G, Arasappa R, Christopher R, Gangadhar BN. Effect of yoga therapy on plasma oxytocin and facial emotion recognition deficits in patients of schizophrenia. Indian J Psychiatry. 2013 Jul;55(Suppl 3):S409-13. doi: 10.4103/0019-5545.116318.
Reference Type
BACKGROUND
Birchwood M, Smith J, Drury V, Healy J, Macmillan F, Slade M. A self-report Insight Scale for psychosis: reliability, validity and sensitivity to change. Acta Psychiatr Scand. 1994 Jan;89(1):62-7. doi: 10.1111/j.1600-0447.1994.tb01487.x.
Reference Type
BACKGROUND
Chang CK, Hayes RD, Perera G, Broadbent MT, Fernandes AC, Lee WE, Hotopf M, Stewart R. Life expectancy at birth for people with serious mental illness and other major disorders from a secondary mental health care case register in London. PLoS One. 2011;6(5):e19590. doi: 10.1371/journal.pone.0019590. Epub 2011 May 18.
Reference Type
BACKGROUND
Cramer H, Lauche R, Haller H, Langhorst J, Dobos G. Mindfulness- and Acceptance-based Interventions for Psychosis: A Systematic Review and Meta-analysis. Glob Adv Health Med. 2016 Jan;5(1):30-43. doi: 10.7453/gahmj.2015.083. Epub 2016 Jan 1.
Reference Type
BACKGROUND
Dollfus S, Mach C, Morello R. Self-Evaluation of Negative Symptoms: A Novel Tool to Assess Negative Symptoms. Schizophr Bull. 2016 May;42(3):571-8. doi: 10.1093/schbul/sbv161. Epub 2015 Nov 12.
Reference Type
BACKGROUND
Duraiswamy G, Thirthalli J, Nagendra HR, Gangadhar BN. Yoga therapy as an add-on treatment in the management of patients with schizophrenia--a randomized controlled trial. Acta Psychiatr Scand. 2007 Sep;116(3):226-32. doi: 10.1111/j.1600-0447.2007.01032.x.
Reference Type
BACKGROUND
Foussias G, Agid O, Fervaha G, Remington G. Negative symptoms of schizophrenia: clinical features, relevance to real world functioning and specificity versus other CNS disorders. Eur Neuropsychopharmacol. 2014 May;24(5):693-709. doi: 10.1016/j.euroneuro.2013.10.017. Epub 2013 Nov 11.
Reference Type
BACKGROUND
Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
Reference Type
BACKGROUND
Kolbaek P, Blicher AB, Buus CW, Feller SG, Holm T, Dines D, O'Leary KM, Sorensen RS, Opler M, Correll CU, Mors O, Bech P, Ostergaard SD. Inter-rater reliability of ratings on the six-item Positive and Negative Syndrome Scale (PANSS-6) obtained using the Simplified Negative and Positive Symptoms Interview (SNAPSI). Nord J Psychiatry. 2018 Aug;72(6):431-436. doi: 10.1080/08039488.2018.1492014. Epub 2018 Jul 24.
Reference Type
BACKGROUND
Krause M, Zhu Y, Huhn M, Schneider-Thoma J, Bighelli I, Nikolakopoulou A, Leucht S. Antipsychotic drugs for patients with schizophrenia and predominant or prominent negative symptoms: a systematic review and meta-analysis. Eur Arch Psychiatry Clin Neurosci. 2018 Oct;268(7):625-639. doi: 10.1007/s00406-018-0869-3. Epub 2018 Jan 24.
Reference Type
BACKGROUND
Leucht S. Measurements of response, remission, and recovery in schizophrenia and examples for their clinical application. J Clin Psychiatry. 2014;75 Suppl 1:8-14. doi: 10.4088/JCP.13049su1c.02.
Reference Type
BACKGROUND
Leucht S, Leucht C, Huhn M, Chaimani A, Mavridis D, Helfer B, Samara M, Rabaioli M, Bacher S, Cipriani A, Geddes JR, Salanti G, Davis JM. Sixty Years of Placebo-Controlled Antipsychotic Drug Trials in Acute Schizophrenia: Systematic Review, Bayesian Meta-Analysis, and Meta-Regression of Efficacy Predictors. Am J Psychiatry. 2017 Oct 1;174(10):927-942. doi: 10.1176/appi.ajp.2017.16121358. Epub 2017 May 25.
Reference Type
BACKGROUND
Ostergaard SD, Lemming OM, Mors O, Correll CU, Bech P. PANSS-6: a brief rating scale for the measurement of severity in schizophrenia. Acta Psychiatr Scand. 2016 Jun;133(6):436-44. doi: 10.1111/acps.12526. Epub 2015 Nov 12.
Reference Type
BACKGROUND
Ostergaard SD, Opler MGA, Correll CU. Bridging the Measurement Gap Between Research and Clinical Care in Schizophrenia: Positive and Negative Syndrome Scale-6 (PANSS-6) and Other Assessments Based on the Simplified Negative and Positive Symptoms Interview (SNAPSI). Innov Clin Neurosci. 2017 Dec 1;14(11-12):68-72.
Reference Type
BACKGROUND
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
Reference Type
BACKGROUND
Spijkerman MP, Pots WT, Bohlmeijer ET. Effectiveness of online mindfulness-based interventions in improving mental health: A review and meta-analysis of randomised controlled trials. Clin Psychol Rev. 2016 Apr;45:102-14. doi: 10.1016/j.cpr.2016.03.009. Epub 2016 Apr 1.
Reference Type
BACKGROUND
Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
Reference Type
BACKGROUND
Uebelacker L, Dufour SC, Dinerman JG, Walsh SL, Hearing C, Gillette LT, Deckersbach T, Nierenberg AA, Weinstock L, Sylvia LG. Examining the Feasibility and Acceptability of an Online Yoga Class for Mood Disorders: A MoodNetwork Study. J Psychiatr Pract. 2018 Jan;24(1):60-67. doi: 10.1097/PRA.0000000000000286.
Reference Type
BACKGROUND
van der Krieke L, Wunderink L, Emerencia AC, de Jonge P, Sytema S. E-mental health self-management for psychotic disorders: state of the art and future perspectives. Psychiatr Serv. 2014 Jan 1;65(1):33-49. doi: 10.1176/appi.ps.201300050.
Reference Type
BACKGROUND
Vancampfort D, Vansteelandt K, Scheewe T, Probst M, Knapen J, De Herdt A, De Hert M. Yoga in schizophrenia: a systematic review of randomised controlled trials. Acta Psychiatr Scand. 2012 Jul;126(1):12-20. doi: 10.1111/j.1600-0447.2012.01865.x. Epub 2012 Apr 6.
Reference Type
BACKGROUND
Varambally S, Gangadhar BN. Yoga: a spiritual practice with therapeutic value in psychiatry. Asian J Psychiatr. 2012 Jun;5(2):186-9. doi: 10.1016/j.ajp.2012.05.003. Epub 2012 May 18.
Reference Type
BACKGROUND
Varambally S, Gangadhar BN, Thirthalli J, Jagannathan A, Kumar S, Venkatasubramanian G, Muralidhar D, Subbakrishna DK, Nagendra HR. Therapeutic efficacy of add-on yogasana intervention in stabilized outpatient schizophrenia: Randomized controlled comparison with exercise and waitlist. Indian J Psychiatry. 2012 Jul;54(3):227-32. doi: 10.4103/0019-5545.102414.
Reference Type
BACKGROUND
Visceglia E, Lewis S. Yoga therapy as an adjunctive treatment for schizophrenia: a randomized, controlled pilot study. J Altern Complement Med. 2011 Jul;17(7):601-7. doi: 10.1089/acm.2010.0075.
Reference Type
BACKGROUND
Wolever RQ, Bobinet KJ, McCabe K, Mackenzie ER, Fekete E, Kusnick CA, Baime M. Effective and viable mind-body stress reduction in the workplace: a randomized controlled trial. J Occup Health Psychol. 2012 Apr;17(2):246-258. doi: 10.1037/a0027278. Epub 2012 Feb 20.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Efficacy of a Brief Online Mindfulness and Self-Compassion Intervention (Mind-OP+) to Increase Connectedness
NCT05871554
COMPLETED
NA
Mindfulness-Based Family Psychoeducation Intervention for Early Psychosis
NCT03688009
COMPLETED
NA
Examining the Effects of Regular Brief Internet-based Meditation Practice on Mental Health and Well Being
NCT06014281
ACTIVE_NOT_RECRUITING
NA
Finding Wellness in the Pandemic
NCT04615741
COMPLETED
NA
The Effects of Yoga on Student Mental Health
NCT04258540
COMPLETED
NA
Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)
NCT03609450
TERMINATED
NA
Optimizing Daily Mindfulness Interventions Using Peer Support to Increase Well-Being in First-Year Students
NCT04828291
UNKNOWN
NA
Long-Covid-19 Alleviation Through Learning Mindfulness Study
NCT07140094
RECRUITING
NA
Mindfulness and Lifestyle Interventions for Depression and Anxiety: A Pilot Study
NCT01230047
UNKNOWN
NA
Yoga Intervention for Compulsive Sexual Behavior Disorder
NCT04634175
ENROLLING_BY_INVITATION
NA
Mindfulness Intervention and Online Social Networking
NCT06090760
COMPLETED
NA
Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions
NCT05211960
COMPLETED
NA
Qigong and Social Isolation: Mental Health Benefits
NCT05081297
COMPLETED
NA
Can Brief-mindfulness Interventions Improve Psychiatric Symptoms?
NCT02987426
COMPLETED
PHASE2/PHASE3
Online Mindfulness-based Program for Parents of Children With Autism
NCT05913869
ACTIVE_NOT_RECRUITING
NA
Tools for Wellbeing COVID-19 National Study of Undergraduate Students
NCT04414371
UNKNOWN
NA
Online Multi-component Psychological Intervention for Depression, Anxiety and Well-being in 7 Countries
NCT05443139
UNKNOWN
NA
Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder
NCT01914874
COMPLETED
NA
Mindfulness RCT for Early Psychosis
NCT02244970
UNKNOWN
NA
Online Exercise Intervention for Psychosis Patients Receiving Residential Care
NCT04631952
UNKNOWN
NA
An Experimental Study of Psychological Effect of School Based-Yoga on Low-Income School Children
NCT03960944
COMPLETED
NA
Feasibility Study for Online Mindfulness for GAD
NCT05059834
COMPLETED
NA
Formal Versus Informal Mindfulness Among University Students With and Without Recent Nonsuicidal Self-injury
NCT05608304
COMPLETED
NA
Effects of Mindfulness and Yoga on Preschool Students' Emotional Regulation, Behavior, and Social Participation
NCT06561373
NOT_YET_RECRUITING
NA