PsychosisNCT05046912
Online Yoga and the Impact on Psychosis
A study testing Yoga and Mindfulness in people with Psychosis, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis
- What is being tested?
- Yoga and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 11 Nov 2021to 5 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Royal Ottawa Mental Heatlh Centre
Ottawa, Ontario, K1Z7K4
Michael Bodnar, PhD
About this study
Official title: Exploring the Impact of Online Yoga on Outcome and Recovery in People With Psychosis.
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
8 weeks of online weekly yoga or chair yoga class
MindfulnessBehavioural
8 weeks of online weekly mindfulness class
| Study group | Role | What they receive |
|---|---|---|
| Clinical | Experimental | Clinical participants with a primary diagnosis of psychosis or related disorder. Receives: Behavioral: Yoga; Behavioral: Mindfulness |
| Non-clinical | Active comparator | Non-clinical participants with no mental health diagnoses. Receives: Behavioral: Yoga; Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start11 Nov 2021
- Primary completion5 Nov 2022 (estimated)
- Study completion5 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical and non-clinical participants will be assigned to either a yoga or mindfulness condition.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Bodnar, PhD, Principal investigator, The Royal Ottawa Mental Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046912
- Sponsor's protocol ID
- 2021021
- Status last verified
- Sep 2021
- First submitted
- 15 Jun 2021
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26652054Andersson 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.
PubMed 30600624Aust 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 27928859Bartels 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.
PubMed 14609805Jayaram 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 24049210Birchwood 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 7908156Chang 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 21611123Cramer 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 26937312Dollfus 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 26564898Duraiswamy 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 17655565Foussias 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 24275699Kay 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 3616518Kolbaek 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 30037286Krause 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 29368205Leucht 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.
PubMed 24581453
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Online Yoga on Outcome and Recovery in People With Psychosis.
- ClinicalTrials.gov ID
- NCT05046912
- Acronym / sponsor ID
- 2021021
- Conditions
- Psychosis
- Keywords
- Psychosis, Yoga, Mindfulness, Recovery, Online
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Royal Ottawa Mental Health CentreUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 5 Nov 2022 (estimated)
- Study completion
- 5 Nov 2022 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical and non-clinical participants will be assigned to either a yoga or mindfulness condition.
| Arm | Type | Receives |
|---|---|---|
| Clinical | Experimental | Behavioral: Yoga, Behavioral: MindfulnessClinical participants with a primary diagnosis of psychosis or related disorder. |
| Non-clinical | Active comparator | Behavioral: Yoga, Behavioral: MindfulnessNon-clinical participants with no mental health diagnoses. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga8 weeks of online weekly yoga or chair yoga class | Behavioural | Clinical, Non-clinical |
| Mindfulness8 weeks of online weekly mindfulness class | Behavioural | Clinical, Non-clinical |
Primary outcome
Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at week 4
Time frame: Baseline and 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).
Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at week 8
Time frame: Baseline and 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).
Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at week 12
Time frame: Baseline and 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).
Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at 6 months
Time frame: Baseline and 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).
Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 4 weeks
Time frame: Baseline and Week 4
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).
Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 8 weeks
Time frame: Baseline and Week 8
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).
Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 12 weeks
Time frame: Baseline and Week 12
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).
Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 6 months
Time frame: Baseline and 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).
Change from baseline on the Questionnaire about the Process of Recovery - Version 2 (QPR-2) scale at week 4
Time frame: Baseline and 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).
Change from baseline on the Questionnaire about the Process of Recovery - Version 2 (QPR-2) scale at week 8
Time frame: Baseline and 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).
Change from baseline on the Questionnaire about the Process of Recovery - Version 2 (QPR-2) scale at week 12
Time frame: Baseline and 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).
Change from baseline on the Questionnaire about the Process of Recovery - Version 2 (QPR-2) scale at 6 months
Time frame: Baseline and 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).
Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at week 4
Time frame: Baseline and 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).
Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at week 8
Time frame: Baseline and 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).
Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at week 12
Time frame: Baseline and 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).
Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at 6 months
Time frame: Baseline and 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).
Change from baseline on the Birchwood Insight Scale (BIS) scale at week 4
Time frame: Baseline and 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).
Change from baseline on the Birchwood Insight Scale (BIS) scale at week 8
Time frame: Baseline and 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).
Change from baseline on the Birchwood Insight Scale (BIS) scale at week 12
Time frame: Baseline and 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).
Change from baseline on the Birchwood Insight Scale (BIS) scale at 6 months
Time frame: Baseline and 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).
Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at week 4
Time frame: Baseline and 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).
Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at week 8
Time frame: Baseline and 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).
Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at week 12
Time frame: Baseline and 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).
Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at 6 months
Time frame: Baseline and 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).
Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at week 4
Time frame: Baseline and 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).
Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at week 8
Time frame: Baseline and 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).
Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at week 12
Time frame: Baseline and 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).
Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at 6 months
Time frame: Baseline and 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Background: PubMed 26652054Andersson G. Internet-Delivered Psychological Treatments. Annu Rev Clin Psychol. 2016;12:157-79. doi: 10.1146/annurev-clinpsy-021815-093006. Epub 2015 Dec 11.
- Background: PubMed 30600624Andersson 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.
- Background: PubMed 27928859Aust 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.
- Background: PubMed 14609805Bartels 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.
- Background: PubMed 24049210Jayaram 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.
- Background: PubMed 7908156Birchwood 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.
- Background: PubMed 21611123Chang 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.
- Background: PubMed 26937312Cramer 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.
- Background: PubMed 26564898Dollfus 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.
- Background: PubMed 17655565Duraiswamy 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.
- Background: PubMed 24275699Foussias 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.
- Background: PubMed 3616518Kay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bodnar, PhD principal investigator
The Royal Ottawa Mental Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and Mindfulness in people with Psychosis, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Bodnar, PhD ((613) 722-6521 ext. 6711, michael.bodnar@theroyal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at week 4 (time frame: Baseline and Week 4). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05046912, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.