Online Yoga and the Impact on Psychosis

Psychosis Clinical Trial

Official title:

Exploring the Impact of Online Yoga on Outcome and Recovery in People With Psychosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05046912
• Other study ID #: 2021021
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: November 5, 2022

Study information

• Verified date: September 2021
• Source: The Royal Ottawa Mental Health Centre
• Contact: Michael Bodnar, PhD
• Phone: (613) 722-6521
• Email: michael.bodnar[@]theroyal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: November 5, 2022
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Yoga
8 weeks of online weekly yoga or chair yoga class
• Mindfulness
8 weeks of online weekly mindfulness class

Locations

Country	Name	City	State
Canada	The Royal Ottawa Mental Heatlh Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Ottawa Mental Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (28)

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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. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and Week 4
Primary	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).	Baseline and Week 8
Primary	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).	Baseline and Week 12
Primary	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).	Baseline and 6 Months
Primary	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).	Baseline and Week 4
Primary	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).	Baseline and Week 8
Primary	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).	Baseline and Week 12
Primary	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).	Baseline and 6 Months
Primary	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).	Baseline and Week 4
Primary	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).	Baseline and Week 8
Primary	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).	Baseline and Week 12
Primary	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).	Baseline and 6 Months
Primary	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).	Baseline and Week 4
Primary	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).	Baseline and Week 8
Primary	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).	Baseline and Week 12
Primary	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).	Baseline and 6 Months
Primary	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).	Baseline and Week 4
Primary	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).	Baseline and Week 8
Primary	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).	Baseline and Week 12
Primary	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).	Baseline and 6 Months
Primary	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).	Baseline and Week 4
Primary	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).	Baseline and Week 8
Primary	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).	Baseline and Week 12
Primary	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).	Baseline and 6 Months
Primary	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).	Baseline and Week 4
Primary	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).	Baseline and Week 8
Primary	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).	Baseline and Week 12
Primary	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).	Baseline and 6 Months