Recruiting

Meditation & Biofeedback

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05845541

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Technology Supported Meditation and Biofeedback

Standard Treatment

Study Details

Brief summary:

The goal of this clinical trial is to investigate the impact of a technology-based meditation program in the inpatient stroke population. It will explore how this approach can support patient-centred, holistic, compassionate care by reducing symptoms of depression and anxiety and improving quality of life. Patients will be recruited from the inpatient stroke rehabilitation unit and will have sustained a stroke in the past 2 months. The main question\[s\] it aims to answer are:

1. Is using a technology-based meditation program in the prevention and/or improvement of post stroke depression and anxiety effective for inpatient stroke survivors?
2. Does using a technology-based meditation program support patient-centered, holistic and compassionate care and result in improved measures of quality of life?

Those in the treatment arm will be asked to complete the following:

  • complete an outcome survey on admission and discharge
  • participate in meditation therapy at least three times per week for a minimum of 10 minutes per session.

Participate in education and demonstration of the meditation app and use of the iom2 device

  • use the iom2 (technology supported meditation and biofeedback) device to monitor heart rate variability and resonance scores
  • participate in an informal discussion re: experience with software and biofeedback

In this randomized controlled trial, those allocated to the control group (standard care) will undergo their usual inpatient rehabilitation but will be asked to complete the outcome measures on admission and prior to hospital discharge.

To maximize data collection, we will offer qualitative interviews with patients and focus groups with staff to understand the perceived benefits of meditation technology for stroke patients.

Conditions

Stroke

Study ID

NCT05845541

Start date

Dec 1, 2023

Status verified date

Jul, 2024

Completion date

Nov 30, 2024

Anticipated

Primary completion date

Oct 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult (18 years and older)
  • Inpatient rehabilitation patients at St. John's Rehab
  • Experienced a stroke within the past two months prior to study enrollment
  • Identified as being at risk for depression and/or anxiety based on their scores on study screening tools
  • Able to comply with study requirements

Exclusion Criteria:

  • Younger than 18 years old
  • Significant comorbidity including psychiatric or neurological disorder (not including premorbid depression or anxiety)
  • Inability to complete any of the outcome measures
  • Starting a new antidepressant or a change in antidepressant medication within the past 6 months
  • Inability to provide informed consent

  • For qualitative interviews, patients can have experienced a stroke within one year.
  • For focus groups, staff who work significantly with stroke patients at St. John's Rehab. Staff can be physicians, nurses, allied health.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Technology Supported Meditation

Patient's randomized to the treatment arm will receive technology-based meditation therapy at least three times per week for a minimum of 10 minutes per session. They will participate in sessions throughout the length of their inpatient stay via the iom2 device and the interactive meditation software. Signals from the iom2 are then sent to an App on a phone, tablet or personal computer that generates biofeedback information and allows patients to adjust their breathing based on the feedback. The interactive Meditation programs teach specific breathing, mindfulness and relaxation techniques to increase a person's heart rate variability (HRV). Doing so provides the participant with instantaneous awareness of their nervous system state, which helps them to learn to directly influence their HRV.

active comparator: Standard Treatment

Patients at St. John's Rehab undergoing rehabilitation are supported by an interprofessional team - including physiatrists, nurses, occupational therapists, speech language pathologists, physical therapists, social workers and psychiatrists. During their inpatient stay, patients receive a wide range of rehabilitation services aimed at addressing their physical, emotional and cognitive care needs. Length of stay for inpatient services ranges between 2 to 12 weeks.

Interventions

Technology Supported Meditation and Biofeedback

Patient's in the treatment arm will participate in technology based meditation using the iom2 and Journeys app at least 3 times/ week. This will involve placing a probe on their ear attached to the iom2 and following the guidance provided by the Journeys App.

During and following each session, participants will be shown their average heart rate variability (HRV) score, average HRV, and time spent on the session. Patients will be able to review sessions and keep track of their progress. Participants in the intervention arm will be asked to complete the outcome measures prior to their hospital discharge. As well, an informal discussion about the patient's experience using technology based meditation will be transcribed.

Standard Treatment

Patients at St. John's Rehab undergoing rehabilitation are supported by an interprofessional team - including physiatrists, nurses, occupational therapists, speech language pathologists, physical therapists, social workers and psychiatrists. During their inpatient stay, patients receive a wide range of rehabilitation services aimed at addressing their physical, emotional and cognitive care needs. Length of stay for inpatient services ranges between 2 to 12 weeks.

Primary outcome measure

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1) Pre-intervention: up to 2 weeks before the intervention start date. 2) Post-intervention: up to 2 weeks after the intervention end date. ]
  • The Stroke Aphasic Depression Questionnaire-10 (SADQ-10) [ Time Frame: 1) Pre-intervention: up to 2 weeks before the intervention start date. 2) Post-intervention: up to 2 weeks after the intervention end date. ]
  • Stroke Specific Quality of Life Scale (SS-QOL) [ Time Frame: 1) Pre-intervention: up to 2 weeks before the intervention start date. 2) Post-intervention: up to 2 weeks after the intervention end date. ]
  • The Behavioural Outcomes of Anxiety scale (BOA) [ Time Frame: 1) Pre-intervention: up to 2 weeks before the intervention start date. 2) Post-intervention: up to 2 weeks after the intervention end date. ]
  • The Positive and Negative Affect Schedule (PANAS) [ Time Frame: 1) Pre-intervention: up to 2 weeks before the intervention start date. 2) Post-intervention: up to 2 weeks after the intervention end date. ]

Central Contacts and Locations

Central contacts

Amanda Ratner, M.H.Sc.

416-226-6780amanda.ratner@sunnybrook.ca

Eva Cohen, B.Sc.

416-226-6780eva.cohen@sri.utoronto.ca

Locations

St. John's Rehab

Recruiting

Toronto, Ontario, Canada, M2M2G1

Contacts

Amanda Ratner, MHSc, MSc

416-226-6780amanda.ratner@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Aug 12, 2024

Last verified

Jul, 2024

Keywords

  • Stroke
  • Meditation
  • Biofeedback
  • Depression
  • Anxiety
  • Inpatient

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-08-12.