Clinical trial NCT05046912: Online Yoga and the Impact on Psychosis
Official title: Exploring the Impact of Online Yoga on Outcome and Recovery in People With Psychosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosis
Keywords: Psychosis
Yoga
Mindfulness
Recovery
Online
Lead sponsor: The Royal Ottawa Mental Health Centre
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical and non-clinical participants will be assigned to either a yoga or mindfulness condition.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at week 12
timeFrame: Baseline and Week 12
measure: Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at 6 months
timeFrame: Baseline and 6 Months
measure: Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 4 weeks
timeFrame: Baseline and Week 4
measure: Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 8 weeks
timeFrame: Baseline and Week 8
measure: Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 12 weeks
timeFrame: Baseline and Week 12
measure: Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 6 months
timeFrame: Baseline and 6 Months
measure: Change from baseline on the Questionnaire about the Process of Recovery - Version 2 (QPR-2) scale at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline on the Questionnaire about the Process of Recovery - Version 2 (QPR-2) scale at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline on the Questionnaire about the Process of Recovery - Version 2 (QPR-2) scale at week 12
timeFrame: Baseline and Week 12
measure: Change from baseline on the Questionnaire about the Process of Recovery - Version 2 (QPR-2) scale at 6 months
timeFrame: Baseline and 6 Months
measure: Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at week 12
timeFrame: Baseline and Week 12
measure: Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at 6 months
timeFrame: Baseline and 6 Months
measure: Change from baseline on the Birchwood Insight Scale (BIS) scale at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline on the Birchwood Insight Scale (BIS) scale at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline on the Birchwood Insight Scale (BIS) scale at week 12
timeFrame: Baseline and Week 12
measure: Change from baseline on the Birchwood Insight Scale (BIS) scale at 6 months
timeFrame: Baseline and 6 Months
measure: Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at week 12
timeFrame: Baseline and Week 12
measure: Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at 6 months
timeFrame: Baseline and 6 Months
measure: Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at week 12
timeFrame: Baseline and Week 12
measure: Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at 6 months
timeFrame: Baseline and 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Royal Ottawa Mental Heatlh Centre
state: Ontario
Study officials:
affiliation: The Royal Ottawa Mental Health Centre
name: Michael Bodnar, PhD
role: PRINCIPAL_INVESTIGATOR
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