Recruiting

Yoga

Sponsor:

The Royal Ottawa Mental Health Centre

Code:

NCT05046912

Conditions

Psychosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Yoga

Mindfulness

Study Details

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.

Conditions

Psychosis

Study ID

NCT05046912

Start date

Nov 11, 2021

Status verified date

Sep, 2021

Completion date

Nov 5, 2022

Anticipated

Primary completion date

Nov 5, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clinical

Clinical participants with a primary diagnosis of psychosis or related disorder.

active comparator: Non-clinical

Non-clinical participants with no mental health diagnoses.

Interventions

Yoga

8 weeks of online weekly yoga or chair yoga class

Mindfulness

8 weeks of online weekly mindfulness class

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 ]
  • Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at week 8 [ Time Frame: Baseline and Week 8 ]
  • Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at week 12 [ Time Frame: Baseline and Week 12 ]
  • Change from baseline on the Clinical Outcomes in Routine Evaluation (CORE-10) scale at 6 months [ Time Frame: Baseline and 6 Months ]
  • Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 4 weeks [ Time Frame: Baseline and Week 4 ]
  • Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 8 weeks [ Time Frame: Baseline and Week 8 ]
  • Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 12 weeks [ Time Frame: Baseline and Week 12 ]
  • Change from baseline on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scale at 6 months [ 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 [ 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 [ 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 [ 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 [ Time Frame: Baseline and 6 Months ]
  • Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at week 4 [ Time Frame: Baseline and Week 4 ]
  • Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at week 8 [ Time Frame: Baseline and Week 8 ]
  • Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at week 12 [ Time Frame: Baseline and Week 12 ]
  • Change from baseline on the Self-Evaluation of Negative Symptoms (SNS) scale at 6 months [ Time Frame: Baseline and 6 Months ]
  • Change from baseline on the Birchwood Insight Scale (BIS) scale at week 4 [ Time Frame: Baseline and Week 4 ]
  • Change from baseline on the Birchwood Insight Scale (BIS) scale at week 8 [ Time Frame: Baseline and Week 8 ]
  • Change from baseline on the Birchwood Insight Scale (BIS) scale at week 12 [ Time Frame: Baseline and Week 12 ]
  • Change from baseline on the Birchwood Insight Scale (BIS) scale at 6 months [ Time Frame: Baseline and 6 Months ]
  • Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at week 4 [ Time Frame: Baseline and Week 4 ]
  • Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at week 8 [ Time Frame: Baseline and Week 8 ]
  • Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at week 12 [ Time Frame: Baseline and Week 12 ]
  • Change from baseline on the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS) scale at 6 months [ Time Frame: Baseline and 6 Months ]
  • Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at week 4 [ Time Frame: Baseline and Week 4 ]
  • Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at week 8 [ Time Frame: Baseline and Week 8 ]
  • Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at week 12 [ Time Frame: Baseline and Week 12 ]
  • Change from baseline on the Modified Global Assessment of Functioning - Revised (M-GAF(R)) scale at 6 months [ Time Frame: Baseline and 6 Months ]

Central Contacts and Locations

Central contacts

Michael Bodnar, PhD

(613) 722-6521michael.bodnar@theroyal.ca

Locations

The Royal Ottawa Mental Heatlh Centre

Recruiting

Ottawa, Ontario, Canada, K1Z7K4

More Information

Sponsor

The Royal Ottawa Mental Health Centre

Last update posted

Jun 16, 2022

Last verified

Sep, 2021

Keywords

  • Psychosis
  • Yoga
  • Mindfulness
  • Recovery
  • Online

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Royal Ottawa Mental Health Centre on 2022-06-16.