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NCT Number: NCT06200909

Self-Care Training for Family Caregivers of Persons With Neurodegeneration

The purpose of this study is to assess whether an 8-week mindfulness program enhances psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability) in primary family caregivers of persons with dementia or a related neurodegenerative disease. A total of 232 primary family caregivers aged 50+ years of age will be recruited for this study and randomized to one of three groups: mindfulness meditation (MM), psychoeducation (PSY) or caregiver respite (CR). All participants will complete three testing sessions: baseline (pre-intervention [T1]), post 8-week follow-up (post-intervention, [T2]), and 12-month follow-up (T3).

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Key information

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The purpose of this study is to assess the benefits of 2 virtual self-care programs - mindfulness meditation or a psychoeducation support group - for family caregivers of persons with a neurodegenerative disorder. Both programs are 8-weeks in length. A third arm will include a respite-ony group, which may be considered "treatment as usual". Outcomes of interest include psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability). All participants will complete three testing sessions: baseline (pre-intervention [T1]), post 8-week follow-up (post-intervention, [T2]), and 12-month follow-up (T3). The target sample is 232 family/informal caregivers, aged 50+ years old. All sessions will be conducted using the Zoom platform. Participants will be required to go to LifeLabs for blood collection. Blood results will be shared with participants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50+ years of age
  • Currently a primary family caregiver
  • Fluent in English

Exclusion criteria

  • Existing mindfulness practice
  • Diagnosed/Presenting with Post-traumatic Stress Disorder; Substance Disorder; Psychosis
  • Unable to attend 8 sessions
  • No access to a computer or high-speed internet
  • Not willing to be randomized

Treatment and study plan

Mindfulness meditation

Other

8-week mindfulness meditation program, based on Kabat-Zinn's MBSR program and modified for caregivers. The intervention will be led by MBSR-trained facilitators.

Psychoeducation

Other

A lecture-style program based on the "10 Keys"TM to Healthy Aging Course, an evidence-based program for older adults. The program will be delivered by a facilitator experienced in delivering similar content.

Wait list control

Other

Participants will receive two hours of respite from their caregiving responsibilities per week, for eight weeks. They will be given the opportunity to participate in either the MM or the PSY condition following completion of testing.

Primary outcomes

  1. Perceived Stress Scale

    Time frame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

    10-item Likert-type scale that measured level of distress in the past month. The questionnaire will be modified to cover the past 2 weeks. Higher scores (range 0-40) indicate greater perceived stress.

  2. Center for Epidemiological Studies - Depression

    Time frame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

    A 20-item Likert-type questionnaire that measures presence of depressive symptoms in the past week. Higher scores (range 0-60) indicate greater depressive symptoms.

Secondary outcomes

  1. Zarit Burden Interview

    Time frame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

    A 22-item Likert-type scale that measures distress surrounding the caregiver role. Greater scores (range 0-88) indicate greater caregiver burden.

  2. Flanker Task

    Time frame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

    The flanker task is a classic test of inhibitory control, in which participants are asked to indicate the direction in which a central arrow points while ignoring an array of "flanking" arrows. Flanker interference (difference in reaction times between congruent and incongruent trials for the correct responses, incongruent-congruent) will be calculated with greater scores indicating greater interference.

  3. Allostatic Load Index

    Time frame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up

    Blood samples will be collected to measure biomarkers of biological stress to create an allostatic load (AL) index. Using the count-based calculation method, biomarker values that fall above the 75th percentile of the sample distribution are categorized as 1 and those below the 75th percentile are categorized as 0; except for DHEA-S, HDL cholesterol, which are categorized as 1 for values that fall below the 25th percentile and 0 for values that fall above the 25th percentile (Seeman et al., 1997). Subsystem scores (metabolic, immune, cardiovascular, neuroendocrine) are created by summing the relative biomarker scores and a total AL index score is calculated by summing all biomarker scores. Greater AL index score indicates greater cumulative biological stress.

Other outcomes

  1. Difficulties in Emotion Regulation - Short Form

    Time frame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

    A 16-item Likert-type scale that measure subjective, trait emotion-regulation ability. Participant respond to questions on a 5-point Likert scale with higher scores (range 16-80) indicating greater emotion dysregulation.

  2. Five Factor Mindfulness Questionnaire - Short Form

    Time frame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

    A 24-item Likert-type questionnaire that measures the 5 facets of trait mindfulness. Subscale scores range from 8 to 40 for the observing, describing, acting with awareness, and non-judging facets, or 7 to 35 for the non-reacting facet, resulting in an overall FFMQ score range of 39 to 195. Higher scores indicate greater trait mindfulness.

  3. Pearlin Mastery Scale

    Time frame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

    This 7-item scale measures the extent to which an individual regards their life chances as being under their personal control. Responses are given on a four-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree"

  4. Self-Compassion Scale

    Time frame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

    26-item Likert type scale the measures self-compassion, with higher scores (range 1-5) indicating greater self-compassion.

  5. WHO Quality of Life Scale - Brief

    Time frame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

    26-item questionnaire that measures satisfaction with quality of life, health and other areas of the respondent's life.Higher scores (range 0-100) indicate greater quality of life.

  6. UMASS Stress Reduction Program Follow-up Questionnaire

    Time frame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

    Questionnaire to assess perceived change driven by participation in a stress reduction program. Will be administered to those in the psychoeducation and mindfulness condition only.

  7. Fear and Resistance to Mindfulness Scale

    Time frame: Up to 1 week prior to participation in mindfulness condition; post-intervention (within 1 week following intervention completion)

    A 29-item scale designed to measure fears and resistances to engaging in mindfulness practice. Items are rated on a five-point Likert scale ranging from 1: Not at all like me to 5 (extremely like me). Will be completed by mindfulness condition only.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Fiocco, PhD

CONTACT

[email protected]

416-979-5000 ext. 553233

Rhiannon Ueberholz, BA

CONTACT

[email protected]

416-979-5000 ext. 553233

Sponsors and collaborators

Lead sponsor

Toronto Metropolitan University

Other

Registry information

Official study title

Caring for the Family Caregiver: Testing the Effect of Two Wellness Programs That Support the Well-being of Family Caregivers of Persons With Neurodegenerative Disorders

Acronym: MCP

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 11, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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