Viewing Study NCT05046912


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Study NCT ID: NCT05046912
Status: UNKNOWN
Last Update Posted: 2022-06-16
First Post: 2021-06-15
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Online Yoga and the Impact on Psychosis
Sponsor: The Royal Ottawa Mental Health Centre
Organization:

Study Overview

Official Title: Exploring the Impact of Online Yoga on Outcome and Recovery in People With Psychosis.
Status: UNKNOWN
Status Verified Date: 2021-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: