Online Yoga and the Impact on Psychosis

NCT05046912 | Unknown DMC

• 1 other identifier: 2021021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Psychosis; Yoga; Mindfulness; Recovery; Online

Outcome Measures

Primary Outcomes (28)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Clinical

EXPERIMENTAL

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

Behavioral: Yoga; Behavioral: Mindfulness

Non-clinical

ACTIVE COMPARATOR

Non-clinical participants with no mental health diagnoses.

Behavioral: Yoga; Behavioral: Mindfulness

Interventions

Yoga BEHAVIORAL

8 weeks of online weekly yoga or chair yoga class

Clinical; Non-clinical

Mindfulness BEHAVIORAL

8 weeks of online weekly mindfulness class

Clinical; Non-clinical

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead

Study Sites (1)

The Royal Ottawa Mental Heatlh Centre

Ottawa, Ontario, K1Z7K4, Canada

RECRUITING

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MeSH Terms

Conditions

Psychotic Disorders

Interventions

Yoga; Mindfulness

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael Bodnar, PhD

  The Royal Ottawa Mental Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Bodnar, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical and non-clinical participants will be assigned to either a yoga or mindfulness condition.

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: September 16, 2021
• Study Start: November 11, 2021
• Primary Completion: November 5, 2022
• Study Completion: November 5, 2022
• Last Updated: June 16, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)