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

NCT05845541 | Recruiting

• 1 other identifier: 5628
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

Stroke; Meditation; Biofeedback; Depression; Anxiety; Inpatient

Outcome Measures

Primary Outcomes (5)

• Hospital Anxiety and Depression Scale (HADS)

  The HADS is a self-administered measure used to screen for the presence of depression and anxiety. The HADS was developed to provide clinicians with a reliable, valid and easy to use tool for identifying depression and anxiety. The HADS has 14 items in total. Clients are asked to reflect on their mood within the past week. Seven items assess depression, 5 of which are markers for anhedonia (an inability to experience pleasure), and 2 concern appearance and feelings of slowing down. Seven items assess anxiety, of which 2 assess autonomic anxiety (panic and butterflies in the stomach), and the remaining 5 assess tension and restlessness. Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a depression score (HADS-D). A higher score indicates higher distress. A recent publication in individuals with stroke determined using a cut-off score of 11 for the total HADS, and 8 for the HADS-D .

  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)

  The SADQ was developed to detect depressed mood in aphasic patients. It is a 21-item questionnaire developed based on observable behaviours thought to be associated with depressed mood and is completed by the client's caregiver on behalf of the client. A shortened version of the SADQ has been developed (SADQ-10), which is comprised of 10 questions that best differentiate those with high scores on depression questionnaires from those with low scores. The SADQ-10 is scored by assigning corresponding numeric values to observer selections ("Never" = 0, "Always" = 3), with a higher score indicating more depressive symptoms. In a subsequent study among patients without aphasia, a threshold of 14/30 was found to indicate clinically significant symptoms of depression (70% sensitivity and 77% specificity).

  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)

  The SS-QOL consists of 49 items covering 12 domains: Mobility, Energy, Upper Extremity Function, Work and Productivity, Mood, Self-Care, Social Roles, Family Roles, Vision, Language, Thinking and Personality. Each domain is measured by three to six items using a 5-point (1-5) Likert scale (higher scores indicate better function). An average non-weighted raw score for each domain can be generated. The overall SS-QOL summary score is most often used as the primary outcome, although the separate domain scores are helpful for identifying specific areas that are affected by stroke or that improve the most or least over time.

  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)

  The BOA is an observational tool. It is designed to measure signs of anxiety that are readily observable by carers. It offers 10 descriptors of anxiety based on diagnostic criteria. It requires individuals select the box which comes closest to how s/he has been feeling in the past week. The scale ranges from "often" (3) to "Never" (0).

  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)

  The PANAS (Watson et al., 1988) is designed to measure positive and negative affect. It is comprised of 20 items that describe different feelings and emotions.

  1) Pre-intervention: up to 2 weeks before the intervention start date. 2) Post-intervention: up to 2 weeks after the intervention end date.

Study Arms (2)

Technology Supported Meditation

EXPERIMENTAL

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.

Behavioral: Technology Supported Meditation and Biofeedback

Standard Treatment

ACTIVE COMPARATOR

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.

Other: Standard Treatment

Interventions

Technology Supported Meditation and Biofeedback BEHAVIORAL

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.

Also known as: iom2 relaxation device by Unyte Health ; Journeys App- Wild Devine

Technology Supported Meditation

Standard Treatment OTHER

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.

Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender data will be obtained, but participant eligibility is not based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Sunnybrook Research Institute: collaborator

Study Sites (1)

St. John's Rehab

Toronto, Ontario, M2M2G1, Canada

RECRUITING

MeSH Terms

Conditions

Stroke; Depression; Anxiety Disorders

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Amanda Ratner, M.Sc.

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Ratner, M.H.Sc.

CONTACT

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

Eva Cohen, B.Sc.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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 mask 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 masking the study staff for a future trial. If the staff becomes unmasked, we will make a note and the coordinator will continue to collect data. However, the person analyzing the survey data will be masked to group allocation (group 1 versus group 2) only.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: December 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 30, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-07

Locations

CA (1)