Status unknownNCT05046912Updated Jun 16, 2022

Online Yoga and the Impact on Psychosis

An interventional study of Yoga and Mindfulness in Psychosis, sponsored by The Royal Ottawa Mental Health Centre. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-16.

Sponsored by The Royal Ottawa Mental Health Centre · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study summary

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.

Read the detailed description

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 studied

Psychosis

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Keywords

Psychosis
Yoga
Mindfulness
Recovery
Online

In context

Psychotic Disorders

1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.

This study's planned enrollment of 36 is below the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

The Royal Ottawa Mental Health Centre is the lead sponsor of 22 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

Exclusion criteria

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 36 participants (estimated)

Study arms

Experimental
Clinical
Clinical participants with a primary diagnosis of psychosis or related disorder.
Behavioral: Yoga · Behavioral: Mindfulness
Active comparator
Non-clinical
Non-clinical participants with no mental health diagnoses.
Behavioral: Yoga · Behavioral: Mindfulness

Interventions

BehavioralYoga
8 weeks of online weekly yoga or chair yoga class
BehavioralMindfulness
8 weeks of online weekly mindfulness class

What researchers measure

Primary outcomes

Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at week 4
The CORE-10 is a self-reported instrument measuring levels of psychological distress in the past week. Possible scores range from 0 (not at all) to 4 (most or all of the time). Higher score = worse outcome. Change = (week 4 - baseline).
Time frame: Baseline and Week 4
Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at week 8
The CORE-10 is a self-reported instrument measuring levels of psychological distress in the past week. Possible scores range from 0 (not at all) to 4 (most or all of the time). Higher score = worse outcome. Change = (week 8 - baseline).
Time frame: Baseline and Week 8
Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at week 12
The CORE-10 is a self-reported instrument measuring levels of psychological distress in the past week. Possible scores range from 0 (not at all) to 4 (most or all of the time). Higher score = worse outcome. Change = (week 12 - baseline).
Time frame: Baseline and Week 12
Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at 6 months
The CORE-10 is a self-reported instrument measuring levels of psychological distress in the past week. Possible scores range from 0 (not at all) to 4 (most or all of the time). Higher score = worse outcome. Change = (6 month - baseline).
Time frame: Baseline and 6 Months
Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 4 weeks
The PANSS is a clinician-rated, semi-structured interview assessing schizophrenia symptom severity over the past week. Possible scores range from 1 (absent) to 7 (extreme). Higher score = worse outcome. Change = (week 4 - baseline).
Time frame: Baseline and Week 4
Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 8 weeks
The PANSS is a clinician-rated, semi-structured interview assessing schizophrenia symptom severity over the past week. Possible scores range from 1 (absent) to 7 (extreme). Higher score = worse outcome. Change = (week 8 - baseline).
Time frame: Baseline and Week 8
Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 12 weeks
The PANSS is a clinician-rated, semi-structured interview assessing schizophrenia symptom severity over the past week. Possible scores range from 1 (absent) to 7 (extreme). Higher score = worse outcome. Change = (week 12 - baseline).
Time frame: Baseline and Week 12
Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 6 months
The PANSS is a clinician-rated, semi-structured interview assessing schizophrenia symptom severity over the past week. Possible scores range from 1 (absent) to 7 (extreme). Higher score = worse outcome. Change = (6 month - baseline).
Time frame: Baseline and 6 Months
Change from baseline on the Questionnaire about the Process of Recovery - Version 2 (QPR-2) scale at week 4
The QPR-2 is a self-reported instrument assessing levels of recovery over the past week. Scores range from 0 (disagree strongly) to 4 (agree strongly). Higher score = better outcome. Change = (week 4 - baseline).
Time frame: Baseline and Week 4
Change from baseline on the Questionnaire about the Process of Recovery - Version 2 (QPR-2) scale at week 8
The QPR-2 is a self-reported instrument assessing levels of recovery over the past week. Scores range from 0 (disagree strongly) to 4 (agree strongly). Higher score = better outcome. Change = (week 8 - baseline).
Time frame: Baseline and Week 8
Change from baseline on the Questionnaire about the Process of Recovery - Version 2 (QPR-2) scale at week 12
The QPR-2 is a self-reported instrument assessing levels of recovery over the past week. Scores range from 0 (disagree strongly) to 4 (agree strongly). Higher score = better outcome. Change = (week 12 - baseline).
Time frame: Baseline and Week 12
Change from baseline on the Questionnaire about the Process of Recovery - Version 2 (QPR-2) scale at 6 months
The QPR-2 is a self-reported instrument assessing levels of recovery over the past week. Scores range from 0 (disagree strongly) to 4 (agree strongly). Higher score = better outcome. Change = (6 months - baseline).
Time frame: Baseline and 6 Months
Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at week 4
The SNS is a self-reported instrument assessing negative symptom severity over the past week. Possible answers are strongly agree, somewhat agree, strongly disagree. Higher score = worse outcome. Change = (week 4 - baseline).
Time frame: Baseline and Week 4
Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at week 8
The SNS is a self-reported instrument assessing negative symptom severity over the past week. Possible answers are strongly agree, somewhat agree, strongly disagree. Higher score = worse outcome. Change = (week 8 - baseline).
Time frame: Baseline and Week 8
Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at week 12
The SNS is a self-reported instrument assessing negative symptom severity over the past week. Possible answers are strongly agree, somewhat agree, strongly disagree. Higher score = worse outcome. Change = (week 12 - baseline).
Time frame: Baseline and Week 12
Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at 6 months
The SNS is a self-reported instrument assessing negative symptom severity over the past week. Possible answers are strongly agree, somewhat agree, strongly disagree. Higher score = worse outcome. Change = (6 months - baseline).
Time frame: Baseline and 6 Months
Change from baseline on the Birchwood Insight Scale (BIS) scale at week 4
The BIS is a self-reported instrument assessing levels of insight without a specific time period. Possible answers are agree, disagree, unsure. Higher score = better outcome. Change = (week 4 - baseline).
Time frame: Baseline and Week 4
Change from baseline on the Birchwood Insight Scale (BIS) scale at week 8
The BIS is a self-reported instrument assessing levels of insight without a specific time period. Possible answers are agree, disagree, unsure. Higher score = better outcome. Change = (week 8 - baseline).
Time frame: Baseline and Week 8
Change from baseline on the Birchwood Insight Scale (BIS) scale at week 12
The BIS is a self-reported instrument assessing levels of insight without a specific time period. Possible answers are agree, disagree, unsure. Higher score = better outcome. Change = (week 12 - baseline).
Time frame: Baseline and Week 12
Change from baseline on the Birchwood Insight Scale (BIS) scale at 6 months
The BIS is a self-reported instrument assessing levels of insight without a specific time period. Possible answers are agree, disagree, unsure. Higher score = better outcome. Change = (6 months - baseline).
Time frame: Baseline and 6 Months
Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at week 4
The SWEMWBS is a self-reported instrument assessing levels of overall mental well-being over the past 2 weeks. Possible scores range from 1 (none of the time) to 5 (all of the time). Higher score = better outcome. Change = (week 4 - baseline).
Time frame: Baseline and Week 4
Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at week 8
The SWEMWBS is a self-reported instrument assessing levels of overall mental well-being over the past 2 weeks. Possible scores range from 1 (none of the time) to 5 (all of the time). Higher score = better outcome. Change = (week 8 - baseline).
Time frame: Baseline and Week 8
Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at week 12
The SWEMWBS is a self-reported instrument assessing levels of overall mental well-being over the past 2 weeks. Possible scores range from 1 (none of the time) to 5 (all of the time). Higher score = better outcome. Change = (week 12 - baseline).
Time frame: Baseline and Week 12
Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at 6 months
The SWEMWBS is a self-reported instrument assessing levels of overall mental well-being over the past 2 weeks. Possible scores range from 1 (none of the time) to 5 (all of the time). Higher score = better outcome. Change = (6 months - baseline).
Time frame: Baseline and 6 Months
Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at week 4
The M-GAF(R) is a clinician-rated instrument assessing overall level of functioning over the past month. Score ranges from 1 (severely impaired) to 100 (superior functioning). Higher score = better outcome. Change = (week 4 - baseline).
Time frame: Baseline and Week 4
Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at week 8
The M-GAF(R) is a clinician-rated instrument assessing overall level of functioning over the past month. Score ranges from 1 (severely impaired) to 100 (superior functioning). Higher score = better outcome. Change = (week 8 - baseline).
Time frame: Baseline and Week 8
Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at week 12
The M-GAF(R) is a clinician-rated instrument assessing overall level of functioning over the past month. Score ranges from 1 (severely impaired) to 100 (superior functioning). Higher score = better outcome. Change = (week 12 - baseline).
Time frame: Baseline and Week 12
Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at 6 months
The M-GAF(R) is a clinician-rated instrument assessing overall level of functioning over the past month. Score ranges from 1 (severely impaired) to 100 (superior functioning). Higher score = better outcome. Change = (6 months - baseline).
Time frame: Baseline and 6 Months

Study locations

1 of 1 sites recruiting

The Royal Ottawa Mental Heatlh Centre
Ottawa, Ontario K1Z7K4, Canada
- Michael Bodnar, PhD · Contact
Recruiting

References and documents

Publications

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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. PubMed 27928859 ↗
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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. PubMed 24049210 ↗
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. PubMed 7908156 ↗
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. PubMed 21611123 ↗
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. PubMed 26937312 ↗
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. PubMed 26564898 ↗
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. PubMed 17655565 ↗
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. PubMed 24275699 ↗
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. PubMed 3616518 ↗
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. PubMed 30037286 ↗
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. PubMed 29368205 ↗
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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. PubMed 28541090 ↗
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Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05046912
Lead sponsor: The Royal Ottawa Mental Health Centre
Responsible party: Sponsor
First posted: Sep 16, 2021
Start date: Nov 11, 2021
Primary completion: Nov 5, 2022 (estimated)
Completion: Nov 5, 2022 (estimated)
Last update: Jun 16, 2022

Study contacts

Michael Bodnar, PhD

Contact

michael.bodnar@theroyal.ca

(613) 722-6521 ext. 6711

Michael Bodnar, PhD

principal investigator · The Royal Ottawa Mental Health Centre

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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