Clinical trial NCT05845541: Meditation and Biofeedback to Improve Anxiety, Depression and Quality of Life in Inpatients After Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Meditation
Biofeedback
Depression
Anxiety
Inpatient
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Sunnybrook Research Institute
First posted: 2023-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot Study using an RCT design will be employed whereby participants are randomly assigned to either a treatment arm (iom2 - technology supported meditation) or control arm (standard care).
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Inpatients at St. John's Rehab Hospital (A3 Unit) who experienced a stroke within the past two months will be approached to participate in the study. A member of the circle of care will identify the potential participant to see if they are interested in learning more about the study. If they are interested, a member of the research team who is NOT part of their care (e.g., research assistant) will undertake the informed consent process. For those individuals identified as experiencing aphasia, a pictographic version of the consent form will be provided. Participants will be given at least 48 hours to review the information before being asked to consent. Once consent is obtained, all participants will be given a survey to complete. The survey includes these measures: the HADS (Hospital Anxiety and Depression Scale) and the SSQOL (Stroke Specific Quality of Life) (if they do not have significant levels of aphasia) or the SADQ-10 (Stroke Aphasic Depression Questionnaire AND the BOA (Behavioural Outcomes of Anxiety) (if they have significant levels of aphasia). For aphasic and non-aphasic patients, the PANAS (Positive and Negative Affect Schedule). These measures will be assessed again before patients are discharged.

For those participants who are 'at risk' for depression or anxiety, the following participant characteristics will be collected: age, sex, type of stroke, location of stroke, date of stroke, visual neglect, presence/type of aphasia, The Functional Independence Measure Scores (FIM) (FIMSM; Uniform Data Set for Medical Rehabilitation, 1996), and the Montreal Cognitive Assessment (MOCA) score (Nassredine et al., 2005). These measures are collected as part of routine standard care for all patients and will be obtained from the participants' charts. Self-identified gender will be obtained via an outcome survey measure administered to the participants at baseline and post-intervention.

A simple randomization method will be used to allocate participants to either the treatment arm or control arm of the study. This randomization will be done prior to start of the study whereby an online randomizer will be used to determine group allocation. A person not involved in the data collection or analysis of the findings will be responsible for generating the randomization sequence (to start with treatment or to start with standard care), and will be blinded to which participants are allocated to which group. Since it is impossible to blind the study participants, we will request they not discuss their group allocation with the coordinator who is collecting the outcome measure data, but it is possible they may inadvertently reveal this to the coordinator. Consequently, this will serve to inform the feasibility of blinding study staff for a future trial. If the staff becomes unblinded, we will make a note and the coordinator will continue to collect data. However, the person analyzing the survey data will be blinded to group allocation (group 1 versus group 2) only.

For those allocated to the control group (standard care), they will undergo their inpatient rehabilitation but will be asked to complete the outcome measures again prior to hospital discharge.

For those allocated to the treatment arm (iom2 - technology supported meditation), participants 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. At their first treatment visit, the participants will be provided education about the study and will be given a brief and simple explanation and demonstration of the meditation App (Journeys). As well, they will be given an overview of the study technology with the patient using simple language and a Guided demonstration of the "Journeys" app and the iom2 device. All participants' will be given the opportunity to ask questions and receive additional support where required. It is expected that participants will be able to engage in these sessions independently but study personnel will be available at the beginning and end of each session to ensure accurate use of the technology, data collection and respond to any questions. During and following each session, participants will be shown their average HRV (Heart Rate Variability) 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. All participants will be thanked for their time on the study and will be provided with a $25 gift card.

Participants will be asked if they are interested in a qualitative interview and staff will be asked if they are interested in participating in a focus group. These additional data collection measures will optimize our understanding of the perceived benefits and barriers to using meditation technology for stroke patients.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1) Pre-intervention: up to 2 weeks before the intervention start date. 2) Post-intervention: up to 2 weeks after the intervention end date.
measure: The Stroke Aphasic Depression Questionnaire-10 (SADQ-10)
timeFrame: 1) Pre-intervention: up to 2 weeks before the intervention start date. 2) Post-intervention: up to 2 weeks after the intervention end date.
measure: Stroke Specific Quality of Life Scale (SS-QOL)
timeFrame: 1) Pre-intervention: up to 2 weeks before the intervention start date. 2) Post-intervention: up to 2 weeks after the intervention end date.
measure: The Behavioural Outcomes of Anxiety scale (BOA)
timeFrame: 1) Pre-intervention: up to 2 weeks before the intervention start date. 2) Post-intervention: up to 2 weeks after the intervention end date.
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: 1) Pre-intervention: up to 2 weeks before the intervention start date. 2) Post-intervention: up to 2 weeks after the intervention end date.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. John's Rehab
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Amanda Ratner, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: