RecruitingNot ApplicableNCT05845541

Meditation and Biofeedback to Improve Anxiety, Depression and Quality of Life in Inpatients After Stroke

Using a Technology-based Meditation Program Administered Through the iom2 Biofeedback Device to Reduce Depression and Anxiety and Improve QOL in the Inpatient Stroke Rehabilitation Setting

Sponsor

Sunnybrook Health Sciences Centre

Enrollment

60 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Stroke

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria7

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.

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Interventions

BEHAVIORALTechnology 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.

OTHERStandard 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.