CaregiversNCT04416529
Tele-Mindfulness for Dementia's Family Caregivers: a Randomized Trial With a Usual Care Control Group
A study testing Tele-MBCT in people with Caregivers and Mindfulness, run by Mount Sinai Hospital, Canada.
Trial summary
Family caregivers were recruited through a combinations of strategies including a larger caregiving project and its partners, memory clinics, community outreach, online advertisement, flyers and brochures and word of mouth. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Caregivers, Mindfulness
- What is being tested?
- Tele-MBCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2016to 7 Nov 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Self-identification as a caregiver for a family member diagnosed with any type of dementia
- English literacy
- Access to a home computer connected to the Internet
- Basic familiarity with using a computer (the ability to check email and download files)
- Score at least 3 on the Single-item measure of self-perceived stress
- Agree to not engage in any formal community-based caregiver support programs, mind-body programs, or psychotherapy until they have completed training and follow-up evaluations
Who cannot join
- Active suicidality and self-harm ideas
- Recent diagnosis of major depression, severe anxiety, psychosis, and bipolar disorder
- Active substance misuse
- Starting on a new psychotropic medication within three months prior to entry into the study
- Involved in formal, professionally led meditation, yoga, or tai chi programs in the previous year
About this study
Family caregivers were recruited through a combinations of strategies including a larger caregiving project and its partners, memory clinics, community outreach, online advertisement, flyers and brochures and word of mouth. After the telephone screening, eligible individuals were scheduled for an in-person baseline meeting at which they received additional information about the study, signed a consent form, completed baseline outcome measures and then were randomized to the intervention or control group using an online randomization program (http://www.graphpad.com/quickcalcs/index.cfm). All participants completed outcome measures immediately post-intervention for the intervention group and at 2 months for the control group and all participants completed follow-up outcome measures at 3 month following the baseline assessment. Participants in the intervention group completed a practice log which was designed to track their daily practice of mindfulness at home. The study was reviewed and approved by the Mount Sinai Hospital Research Ethics Board.
Read the detailed description
Intervention (tele-MBCT) group Tele-MBCT was an 8-week program delivered to participants online via a videoconferencing program called Zoom. Zoom is an Ontario Personal Health Information Act (PHIPA) compliant videoconferencing program that provides remote communication for one-to-one or group meetings. Signing up, one-to-one meetings and attending a meeting as an invitee are free. The host of a group meeting is charged a monthly fee (CAD 14.99-19.99). All hosting fees were paid by the Sinai Health system.
Before starting the intervention, each participant's internet device was checked for compatibility with Zoom. If the device was not compatible, the participant was loaned a tablet for the duration of the intervention which was returned at the end of the study. Each participant was also trained in the use of their device to connect and use the Zoom platform and had an online intake interview with the tele-MBCT instructor.
Before each session, the host emailed the Zoom link to the participants. At the scheduled time of each group session, participants joined the live streamed session via their computers by using the link and following the on-screen instructions. During the live sessions, each participant was able to see, hear and speak with the group leader and other group members and they each could mute/unmute, turn on/off video, send messages via chat box and leave the session at any time if necessary.
The tele-MBCT instructor was a mental health clinician at the Reitman Centre who had a University of Toronto specialist and applied mindfulness certificate and mindfulness training at Mount Sinai Psychotherapy Institute (MSPI). She had extensive experience in developing and delivering online training and services to professionals and caregivers.
Participants in the intervention group were given a mindfulness package which included a book called "The Mindful Way Workbook" (Teasdale, Williams, and Segal 2014), a practice log and a snack pack of raisins (which was needed for the first session for mindful eating practice). "The Mindful Way Workbook" contains information about emotional distress, MBCT foundation and theories, other individuals' experiences with MBCT, weekly practices/explanations and homework. The book also contains a CD audio guide to each week's mindfulness practice. The practice log was a simple log for self-recording daily practices (number of minutes of daily MBCT practice) and a note pad for recording the reasons/obstacles for not practicing. These logs were anonymous and did not include any personal health information of the participants. At the completion of the tele-MBCT training, participants submitted their logs for analysis.
Tele-MBCT was delivered in three, 8-week rounds. Each round consisted of 8 weekly, 2-hour group sessions with 4-6 participants, held via Zoom on Wednesdays from 2:00 to 4:00 pm. For any technical problems during the sessions, participants had telephone access to the instructor.
During tele-MBCT training, participants were trained in mindfulness concepts and techniques including mindful eating, body scan, sitting meditation, breathing awareness, mindful walking and mindful movements. Mindfulness practices, except for mindful walking and mindful movements, were done in a sitting position in a chair or standing. Participants were asked to do the mindful walking with safety measures and in the room in which they were getting the training. The mindful movements were gentle stretches performed in seated and standing positions and were modified to each participant's abilities. At the completion of each session, participants were instructed to practice a specific mindfulness exercise during the week and record them in their practice log. They could use the CD for guided meditation and their home practice. The book also provided them with further readings. At the beginning of the training, participants were asked to set aside 30-45 minutes per day for practice. However, they were free to practice based on their schedule. Participants were permitted to miss up to 2 sessions for unanticipated problems. None of the sessions was audio/video recorded. Missed sessions were made up by reading about the missed session and doing the daily practice according to the book.
For this study, MBCT was modified in two ways for online delivery: omitting the retreat day from the schedule and mindful movements in lying position. In face to face MBCT training, the retreat day is held between sessions 6 and 7 and lasts 5-6 hours, during which individuals spend most of the day together in silence, doing guided practices of the previous sessions. Because of the long hours of the retreat day, it was deemed impractical in an online intervention and omitted. Because of safety issues, it was necessary that all the participants in the group could be seen (via their cameras) by the instructor during the whole training by adjusting the individual's device and finding the best position. This issue was addressed in the Zoom training and the interview with the instructor. Because doing the mindful movement in the lying position required adjustment of the device during the session which was time consuming and challenging, individuals were instructed to do mindful movements only in standing and sitting positions. However, the instructor explained the mindful movements in lying position and encouraged the participants to practice them at home.
Control Group Participants in the control group continued their usual caregiving activities. At 3 months after completion follow-up surveys, they received the "Mindful Way Workbook" and were offered the opportunity to attend the same tele-MBCT training after the study ended.
- Conditions
- Caregivers, Mindfulness
- Being tested
- Tele-MBCT
- Keywords
- family caregivers, Dementia, mindfulness, Online, Internet-based
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-MBCTBehavioural
Please see arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (tele-MBCT) group | Experimental | Tele-MBCT was an 8-week program delivered to participants online via a videoconferencing program called Zoom by a tele-MBCT instructor. Tele-MBCT was delivered in three, 8-week rounds. Each round consisted of 8 weekly, 2-hour group sessions with 4-6 participants on Wednesdays from 2:00 to 4:00 pm. Participants were trained in mindfulness concepts and techniques including mindful eating, body scan, sitting meditation, breathing awareness, mindful walking and mindful movements. Participants were given a mindfulness a book called "The Mindful Way Workbook" and a practice log. The book was a guide for their daily practice at home and the practice log was a simple log for self-recording daily practices (number of minutes of daily MBCT practice) and a note pad for recording the reasons/obstacles for not practicing. Receives: Behavioral: Tele-MBCT |
| Control Group | No intervention | Participants in the control group continued their usual caregiving activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)- 10-item version
Participant's level of stress
Measured: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
Secondary outcomes (4)
Center for Epidemiologic Studies Depression Scale (CES-D)
Participant's symptoms of depression
Measured: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
State Anxiety Subscale of the Spielberger State-Trait Anxiety Inventory (STAI-S)
Current anxiety level
Measured: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
Coping Inventory for Stressful Situations- short form CISS-SF
Participants' coping responses to stressful situations
Measured: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
Self-compassion Scale (SCS)
Participants' level of self-compassion
Measured: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start5 Oct 2016
- Primary completion7 Sep 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaregiversStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to either the intervention group or the control group. All the participant were assessed at baseline, post-intervention and at 4-weeks follow-up.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel Sadavoy, MD, FRCPC, Principal investigator, Department of Psychiatry, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416529
- Sponsor's protocol ID
- 16-0216-E
- Status last verified
- Jun 2020
- First submitted
- 25 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zarei S, Lakhanpal G, Sadavoy J. Tele-Mindfulness for Dementia's Family Caregivers: A Randomized Trial with a Usual Care Control Group. Curr Alzheimer Res. 2022;19(5):364-372. doi: 10.2174/1567205019666220514131015.
PubMed 35570513
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Mindfulness for Dementia's Family Caregivers: a Randomized Trial With a Usual Care Control Group
- ClinicalTrials.gov ID
- NCT04416529
- Acronym / sponsor ID
- 16-0216-E
- Conditions
- Caregivers, Mindfulness
- Keywords
- family caregivers, Dementia, mindfulness, Online, Internet-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 4 Jun 2020 (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.
Family caregivers were recruited through a combinations of strategies including a larger caregiving project and its partners, memory clinics, community outreach, online advertisement, flyers and brochures and word of mouth. After the telephone screening, eligible individuals were scheduled for an in-person baseline meeting at which they received additional information about the study, signed a consent form, completed baseline outcome measures and then were randomized to the intervention or control group using an online randomization program (http://www.graphpad.com/quickcalcs/index.cfm). All participants completed outcome measures immediately post-intervention for the intervention group and at 2 months for the control group and all participants completed follow-up outcome measures at 3 month following the baseline assessment. Participants in the intervention group completed a practice log which was designed to track their daily practice of mindfulness at home. The study was reviewed and approved by the Mount Sinai Hospital Research Ethics Board.
Detailed description
Intervention (tele-MBCT) group Tele-MBCT was an 8-week program delivered to participants online via a videoconferencing program called Zoom. Zoom is an Ontario Personal Health Information Act (PHIPA) compliant videoconferencing program that provides remote communication for one-to-one or group meetings. Signing up, one-to-one meetings and attending a meeting as an invitee are free. The host of a group meeting is charged a monthly fee (CAD 14.99-19.99). All hosting fees were paid by the Sinai Health system.
Before starting the intervention, each participant's internet device was checked for compatibility with Zoom. If the device was not compatible, the participant was loaned a tablet for the duration of the intervention which was returned at the end of the study. Each participant was also trained in the use of their device to connect and use the Zoom platform and had an online intake interview with the tele-MBCT instructor.
Before each session, the host emailed the Zoom link to the participants. At the scheduled time of each group session, participants joined the live streamed session via their computers by using the link and following the on-screen instructions. During the live sessions, each participant was able to see, hear and speak with the group leader and other group members and they each could mute/unmute, turn on/off video, send messages via chat box and leave the session at any time if necessary.
The tele-MBCT instructor was a mental health clinician at the Reitman Centre who had a University of Toronto specialist and applied mindfulness certificate and mindfulness training at Mount Sinai Psychotherapy Institute (MSPI). She had extensive experience in developing and delivering online training and services to professionals and caregivers.
Participants in the intervention group were given a mindfulness package which included a book called "The Mindful Way Workbook" (Teasdale, Williams, and Segal 2014), a practice log and a snack pack of raisins (which was needed for the first session for mindful eating practice). "The Mindful Way Workbook" contains information about emotional distress, MBCT foundation and theories, other individuals' experiences with MBCT, weekly practices/explanations and homework. The book also contains a CD audio guide to each week's mindfulness practice. The practice log was a simple log for self-recording daily practices (number of minutes of daily MBCT practice) and a note pad for recording the reasons/obstacles for not practicing. These logs were anonymous and did not include any personal health information of the participants. At the completion of the tele-MBCT training, participants submitted their logs for analysis.
Tele-MBCT was delivered in three, 8-week rounds. Each round consisted of 8 weekly, 2-hour group sessions with 4-6 participants, held via Zoom on Wednesdays from 2:00 to 4:00 pm. For any technical problems during the sessions, participants had telephone access to the instructor.
During tele-MBCT training, participants were trained in mindfulness concepts and techniques including mindful eating, body scan, sitting meditation, breathing awareness, mindful walking and mindful movements. Mindfulness practices, except for mindful walking and mindful movements, were done in a sitting position in a chair or standing. Participants were asked to do the mindful walking with safety measures and in the room in which they were getting the training. The mindful movements were gentle stretches performed in seated and standing positions and were modified to each participant's abilities. At the completion of each session, participants were instructed to practice a specific mindfulness exercise during the week and record them in their practice log. They could use the CD for guided meditation and their home practice. The book also provided them with further readings. At the beginning of the training, participants were asked to set aside 30-45 minutes per day for practice. However, they were free to practice based on their schedule. Participants were permitted to miss up to 2 sessions for unanticipated problems. None of the sessions was audio/video recorded. Missed sessions were made up by reading about the missed session and doing the daily practice according to the book.
For this study, MBCT was modified in two ways for online delivery: omitting the retreat day from the schedule and mindful movements in lying position. In face to face MBCT training, the retreat day is held between sessions 6 and 7 and lasts 5-6 hours, during which individuals spend most of the day together in silence, doing guided practices of the previous sessions. Because of the long hours of the retreat day, it was deemed impractical in an online intervention and omitted. Because of safety issues, it was necessary that all the participants in the group could be seen (via their cameras) by the instructor during the whole training by adjusting the individual's device and finding the best position. This issue was addressed in the Zoom training and the interview with the instructor. Because doing the mindful movement in the lying position required adjustment of the device during the session which was time consuming and challenging, individuals were instructed to do mindful movements only in standing and sitting positions. However, the instructor explained the mindful movements in lying position and encouraged the participants to practice them at home.
Control Group Participants in the control group continued their usual caregiving activities. At 3 months after completion follow-up surveys, they received the "Mindful Way Workbook" and were offered the opportunity to attend the same tele-MBCT training after the study ended.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized to either the intervention group or the control group. All the participant were assessed at baseline, post-intervention and at 4-weeks follow-up.
| Arm | Type | Receives |
|---|---|---|
| Intervention (tele-MBCT) group | Experimental | Behavioral: Tele-MBCTTele-MBCT was an 8-week program delivered to participants online via a videoconferencing program called Zoom by a tele-MBCT instructor. Tele-MBCT was delivered in three, 8-week rounds. Each round consisted of 8 weekly, 2-hour group sessions with 4-6 participants on Wednesdays from 2:00 to 4:00 pm. Participants were trained in mindfulness concepts and techniques including mindful eating, body scan, sitting meditation, breathing awareness, mindful walking and mindful movements. Participants were given a mindfulness a book called "The Mindful Way Workbook" and a practice log. The book was a guide for their daily practice at home and the practice log was a simple log for self-recording daily practices (number of minutes of daily MBCT practice) and a note pad for recording the reasons/obstacles for not practicing. |
| Control Group | No intervention | –Participants in the control group continued their usual caregiving activities. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identification as a caregiver for a family member diagnosed with any type of dementia
- English literacy
- Access to a home computer connected to the Internet
- Basic familiarity with using a computer (the ability to check email and download files)
- Score at least 3 on the Single-item measure of self-perceived stress
Key exclusion criteria (5 listed)
- Active suicidality and self-harm ideas
- Recent diagnosis of major depression, severe anxiety, psychosis, and bipolar disorder
- Active substance misuse
- Starting on a new psychotropic medication within three months prior to entry into the study
- Involved in formal, professionally led meditation, yoga, or tai chi programs in the previous year
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 |
|---|---|---|
| Tele-MBCTPlease see arm/group description. | Behavioural | Intervention (tele-MBCT) group |
Primary outcome
Perceived Stress Scale (PSS)- 10-item version
Time frame: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
Participant's level of stress
4 secondary outcomes
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
State Anxiety Subscale of the Spielberger State-Trait Anxiety Inventory (STAI-S)
Time frame: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
Coping Inventory for Stressful Situations- short form CISS-SF
Time frame: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
Self-compassion Scale (SCS)
Time frame: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 35570513Zarei S, Lakhanpal G, Sadavoy J. Tele-Mindfulness for Dementia's Family Caregivers: A Randomized Trial with a Usual Care Control Group. Curr Alzheimer Res. 2022;19(5):364-372. doi: 10.2174/1567205019666220514131015.
- Individual participant dataSharing planned: No
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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.
Joel Sadavoy, MD, FRCPC principal investigator
Department of Psychiatry, University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Tele-MBCT in people with Caregivers and Mindfulness, run by Mount Sinai Hospital, 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS)- 10-item version (time frame: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04416529, which also lists 1 linked publication.
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 4 Jun 2020.