StrokeNCT05845541
Meditation and Biofeedback to Improve Anxiety, Depression and Quality of Life in Inpatients After Stroke
A study testing Technology Supported Meditation and Biofeedback and Standard Treatment in people with Stroke, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Technology Supported Meditation and Biofeedback and Standard Treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. John's Rehab
Toronto, Ontario, M2M2G1
Amanda Ratner, MHSc, MSc, 416-226-6780, amanda.ratner@sunnybrook.ca
About this study
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
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:
- Is using a technology-based meditation program in the prevention and/or improvement of post stroke depression and anxiety effective for inpatient stroke survivors?
- Does using a technology-based meditation program support patient-centered, holistic and compassionate care and result in improved measures of quality of life?
Read more
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Technology Supported Meditation and Biofeedback, Standard Treatment
- Keywords
- Stroke, Meditation, Biofeedback, Depression, Anxiety, Inpatient
- Medical subject headings
- Stroke, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology Supported Meditation and BiofeedbackBehavioural
Also called iom2 relaxation device by Unyte Health ; Journeys App- Wild Devine
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 TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 1) Pre-intervention: up to 2 weeks before the intervention start date. 2) Post-intervention: up to 2 weeks after the intervention end date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Dec 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Responsible party
- Sponsor
- Investigators
- Amanda Ratner, M.Sc., Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845541
- Sponsor's protocol ID
- 5628
- Status last verified
- Jul 2024
- First submitted
- 25 Apr 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05845541
- Acronym / sponsor ID
- 5628
- Conditions
- Stroke
- Keywords
- Stroke, Meditation, Biofeedback, Depression, Anxiety, Inpatient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is using a technology-based meditation program in the prevention and/or improvement of post stroke depression and anxiety effective for inpatient stroke survivors?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Technology Supported Meditation | Experimental | Behavioral: Technology Supported Meditation and BiofeedbackPatient'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. |
| Standard Treatment | Active comparator | Other: Standard TreatmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology Supported Meditation and BiofeedbackAlso: iom2 relaxation device by Unyte Health ; Journeys App- Wild DevinePatient'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. | Behavioural | Technology Supported Meditation |
| Standard TreatmentPatients 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 |
Primary outcome
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 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 .
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.
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).
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 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.
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 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).
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Ratner, M.Sc. principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology Supported Meditation and Biofeedback and Standard Treatment in people with Stroke, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Ratner, M.H.Sc. (416-226-6780 ext. 57003, amanda.ratner@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.