Tele-Mindfulness for Dementia's Family Caregivers: a Randomized Trial With a Usual Care Control Group

NCT04416529 | Completed

• 1 other identifier: 16-0216-E
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Caregivers; Mindfulness

Keywords

family caregivers; Dementia; mindfulness; Online; Internet-based

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Scale (PSS)- 10-item version

  Participant's level of stress

  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)

  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)

  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

  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)

  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

Other Outcomes (4)

• Demographics

  At baseline

• Feasibility criteria

  Through study completion, an average of 1 year

• Compliance rate

  at 2 months (post-intervention) only for participants in the intervention group

Study Arms (2)

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.

Behavioral: Tele-MBCT

Control Group

NO INTERVENTION

Participants in the control group continued their usual caregiving activities.

Interventions

Tele-MBCT BEHAVIORAL

Please see arm/group description.

Intervention (tele-MBCT) group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Related Publications (1)

• 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.

  PMID: 35570513 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Joel Sadavoy, MD, FRCPC

  Department of Psychiatry, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 4, 2020
• Study Start: October 5, 2016
• Primary Completion: September 7, 2017
• Study Completion: November 7, 2017
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share