Mindfulness-Based Stress Reduction in Dementia Caregivers

NCT04977245 | Completed

• 1 other identifier: 20-31240
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Aims: The study will contribute to our understanding of how the cultivation of caregiver mindfulness might improve their overall relational well-being (Primary Outcome), their psychological well-being (Secondary Outcome), and have an impact on dementia patients' lifestyles (Other Outcome). Overall, this study will investigate the idea that the fruits of mindfulness training can be leveraged by both the caregiver and the care-recipient, improving the quality of relationship by making their interactions more mutual, connected, empathic and positive. This study aims to additionally elucidate which facets of mindfulness account for caregiver's happiness and psychological well-being. Sample: In this study 40 dementia caregivers will be recruited to participate; 20 will be allocated to the clinical intervention group (i.e., adapted MBSR for caregivers) and 20 to the active control group. Data will be collected pre-post the start of intervention, and at a 3 month follow up. Future orientation: This study may contribute to evidence-based knowledge concerning the efficacy of mindfulness based interventions to support caregiver empowerment, via regaining relationship satisfaction and achieving greater equanimity in the face of stressors.

Conditions

Mindfulness Based Stress Reduction; Caregiver Burnout; Caregiver Stress Syndrome; Dementia; Dementia Frontal; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Outcome Measures

Primary Outcomes (13)

• Change in Experiential Avoidance in Caregiving Questionnaire (EACQ) Score

  The Experiential Avoidance in Caregiving Questionnaire (EACQ) is a 15-item self-report questionnaire measuring experiential avoidance in caregivers. Scores range 15-75, and higher scores indicate greater levels of experiential avoidance.

  Baseline, 21 weeks

• Change in Short Form Zarit Burden Interview (ZBI-SF) Score

  The Zarit Burden Interview (ZBI) assess the stresses experienced by caregivers of patients with dementia. The short form assesses 12 questions about the impact of the patient's disabilities on the caregiver's life, each rated from least (0) to most (4) frequent. Items are summed to calculate the ZBI total score. The ZBI total score ranges from 0 to 48; higher scores denoting more stresses experienced by caregivers.

  Baseline, 21 weeks

• Change in Positive Aspects of Caregiving (PAC) Scale

  The Positive Aspects of Caregiving Scale asks caregivers to rate their agreement/disagreement with 9 statements about positive aspects of caregiving on a 5-point Likert scale from "disagree a lot" to "agree a lot." Scores can range from 9 to 45 with higher scores indicating more subjective positive aspects of providing care to someone.

  Baseline, 21 weeks

• Change Mutuality scale of the Family Care Inventory (FCI-MS) Score

  The Mutuality Scale of the Family Care Inventory will be used for rating mutual concerns and overall relationship satisfaction. The measure consists of 15 items. Scores range from 0-60, higher scores indicate greater relationship satisfaction.

  Baseline, 21 weeks

• Change in Interpersonal Reactivity Index Empathic Concern (IRI-PT) Score

  The Interpersonal Reactivity Index (IRI) was designed to assess empathy, and has 28 items on a 5-point Likert scales (1 = does not describe me well to 5 = describes me very well). The perspective-taking scale assesses the extent to which individuals are able to take on others' points of view. Each of the 4 sub-scales has 7 items and scores range from 7 to 35. Higher scores indicate a greater ability to take on the perspective of other persons in social contexts.

  Baseline, 21 weeks

• Change in Interpersonal Reactivity Index Empathic Concern (IRI-EC) Score

  The Interpersonal Reactivity Index (IRI) was designed to assess empathy, and has 28 items on a 5-point Likert scales (1 = does not describe me well to 5 = describes me very well). The empathetic concern scale assesses the extent of individuals' concern and compassion for others. Each of the 4 sub-scales has 7 items and scores range from 7 to 35. Higher scores indicate a greater amount of empathy for others.

  Baseline, 21 weeks

• Change in Interpersonal Reactivity Index Personal Distress (IRI-PD) Score

  The Interpersonal Reactivity Index (IRI) was designed to assess empathy, and has 28 items on a 5-point Likert scales (1 = does not describe me well to 5 = describes me very well). The personal distress subscale assesses individuals anxiety as a result of other's negative experiences. Each of the 4 sub-scales has 7 items and scores range from 7 to 35. Higher scores indicate a greater amount of personal distress for others' negative situations.

  Baseline, 21 weeks

• Change in Interpersonal Reactivity Index Fantasy (IRI-FS) Score

  The Interpersonal Reactivity Index (IRI) was designed to assess empathy, and has 28 items on a 5-point Likert scales (1 = does not describe me well to 5 = describes me very well).The fantasy subscale assesses the extent to which individuals identify with fictional characters. Each of the 4 sub-scales has 7 items and scores range from 7 to 35. Higher scores indicate a greater ability to identify with fictional characters.

  Baseline, 21 weeks

• Change in Fears of Compassion Scale (FCS): Fear of Compassion for Others Subscale

  This scale is comprised of 10 items and assesses the compassion we feel for others, related to our sensitivity to other people's thoughts and feelings. Scores range from 0 to 40. Higher scores indicate greater fear of compassion for others.

  Baseline, 21 weeks

• Change in Fears of Compassion Scale (FCS): Fear of Compassion from Others Subscale

  This scale is comprised of 13 items the compassion that we experience from others and flowing into the self. Scores range from 0 to 52. Higher scores indicate greater fear of compassion from others.

  Baseline, 21 weeks

• Change in The Awareness of Social Inference Task SIE (TASIT-SIE) Score

  The TASIT test asks participants to watch 16 brief videos of social interactions, and answer 4 "Yes" or "No" questions per video. Answering these questions requires the ability to make inferences based on sarcasm, facial expressions, and other social elements seen in the videos, and measures socioemotional sensitivity. Higher scores indicate better ability to make real-world social inferences.

  Baseline, 21 weeks

• Change in Humor Picture Test Score

  The Humor Picture test presents 8 different scenarios each with 4 potentially humorous outcomes that may be correct funny, straightforward, humorous nonsequitur, or unrelated nonsequitur, and is used to measure humor comprehension. Responses to each of the 4 categories are added together to allow 0-8 points in each category.

  Baseline, 21 weeks

• Change in Social Display Rules Task (SDR) Score

  The SDR task presents 20 hypothetical social scenarios, and asks participants how they should respond to the scenario on a scale ranging from negative to positive responses with 0, 1, or 2 points awarded depending on the response. The test is used to evaluate knowledge of emotional social norms, and scores range from 0 to 40.

  Baseline, 21 weeks

Secondary Outcomes (16)

• Change in Depression Anxiety Stress Scales 21 (DASS-21) Anxiety Scale

  Baseline, 21 weeks

• Change in Depression Anxiety Stress Scales 21 (DASS-21) Stress Scale

  Baseline, 21 weeks

• Change in Depression Anxiety Stress Scales 21 (DASS-21) Depression Scale

  Baseline, 21 weeks

• Change in Difficulties in Emotion Regulation Scale (DERS): Non-acceptance Subscale

  Baseline, 21 weeks

• Change in Difficulties in Emotion Regulation Scale (DERS): Goals Subscale

  Baseline, 21 weeks

Other Outcomes (1)

• Change in Pleasant Events Schedule (PES-AD) Score

  Baseline, 21 weeks

Study Arms (2)

MBSR Intervention

EXPERIMENTAL

The intervention group will take part in a group-based mindfulness-based stress reduction (MBSR) program led by a certified MBSR instructor via Zoom. This MBSR program will have a shortened session length of 1.5 hours compared to the traditional 2 hours, to reduce caregiver burden. Caregivers will be trained in meditation practices, like awareness of one's breath, body scan, and loving kindness meditation. Participants will also learn about mindfulness and stress theory, and have group discussions covering topics such as self-compassion.

Other: Mindfulness-Based Stress Reduction

Self-Guided Meditation eCourse

ACTIVE COMPARATOR

Participants in the active control group will participate in a self-guided, online program named GARDEN. The self guided material teaches skills about increasing the daily experience of positive emotion as a mechanism to assist with stress coping. The program consists of eight skills introduced and discussed over an eight week period.

Other: Self-Guided Mindfulness eCourse

Interventions

Mindfulness-Based Stress Reduction OTHER

Eight MBSR sessions of 1.5 hours per week

Also known as: MBSR, Mindfulness Based Stress Reduction

MBSR Intervention

Self-Guided Mindfulness eCourse OTHER

Six weeks of a mindfulness ecourse, and two weeks of coping skills training led by a licensed neuropsychologist

Self-Guided Meditation eCourse

Eligibility Criteria

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

You may qualify if:

• Adult, 18 or older
• Caregiver for a patient with dementia in personal life and regular weekly contact with the demented patient
• English speaking
• Literate: is able to read course material
• Able to attend weekly classes online via Zoom
• Willing to be randomized and participate in one of two interventions

You may not qualify if:

• Are regularly practicing mindfulness meditation, mindful yoga, or similar mindfulness activities
• Currently experiencing active trauma (PTSD - unresolved, or acute stress disorder) without professional psychological assistance
• Clinical diagnosis of dementia
• Diagnosed with psychotic disorder such as schizophrenia, schizoaffective disorder or bipolar disorder according to the Diagnostic and Statistical Manual-V (DSM-V), and under antipsychotic treatment
• Undergoing treatment for substance abuse
• Vision or hearing impairments that would keep them from adequately participating in the intervention
• Any prior formal training in MBSR
• Acute suicide plans as measured by the Patient Safety Screener

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco UCSF

San Francisco, California, 94158, United States

Location

Related Publications (7)

• Davidson RJ, Kabat-Zinn J, Schumacher J, Rosenkranz M, Muller D, Santorelli SF, Urbanowski F, Harrington A, Bonus K, Sheridan JF. Alterations in brain and immune function produced by mindfulness meditation. Psychosom Med. 2003 Jul-Aug;65(4):564-70. doi: 10.1097/01.psy.0000077505.67574.e3.

  PMID: 12883106 BACKGROUND

• Garland EL, Farb NA, Goldin P, Fredrickson BL. Mindfulness Broadens Awareness and Builds Eudaimonic Meaning: A Process Model of Mindful Positive Emotion Regulation. Psychol Inq. 2015 Oct 1;26(4):293-314. doi: 10.1080/1047840X.2015.1064294. Epub 2015 Nov 24.

  PMID: 27087765 BACKGROUND

• Lindsay EK, Creswell JD. Mechanisms of mindfulness training: Monitor and Acceptance Theory (MAT). Clin Psychol Rev. 2017 Feb;51:48-59. doi: 10.1016/j.cpr.2016.10.011. Epub 2016 Nov 5.

  PMID: 27835764 BACKGROUND

• Li G, Yuan H, Zhang W. The Effects of Mindfulness-Based Stress Reduction for Family Caregivers: Systematic Review. Arch Psychiatr Nurs. 2016 Apr;30(2):292-9. doi: 10.1016/j.apnu.2015.08.014. Epub 2015 Aug 28.

  PMID: 26992885 BACKGROUND

• Steadman PL, Tremont G, Davis JD. Premorbid relationship satisfaction and caregiver burden in dementia caregivers. J Geriatr Psychiatry Neurol. 2007 Jun;20(2):115-9. doi: 10.1177/0891988706298624.

  PMID: 17548782 BACKGROUND

• Campos D, Modrego-Alarcon M, Lopez-Del-Hoyo Y, Gonzalez-Panzano M, Van Gordon W, Shonin E, Navarro-Gil M, Garcia-Campayo J. Exploring the Role of Meditation and Dispositional Mindfulness on Social Cognition Domains: A Controlled Study. Front Psychol. 2019 Apr 11;10:809. doi: 10.3389/fpsyg.2019.00809. eCollection 2019.

  PMID: 31031678 BACKGROUND

• Luberto CM, Shinday N, Song R, Philpotts LL, Park ER, Fricchione GL, Yeh GY. A Systematic Review and Meta-analysis of the Effects of Meditation on Empathy, Compassion, and Prosocial Behaviors. Mindfulness (N Y). 2018 Jun;9(3):708-724. doi: 10.1007/s12671-017-0841-8. Epub 2017 Oct 23.

  PMID: 30100929 BACKGROUND

MeSH Terms

Conditions

Caregiver Burden; Dementia; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Katherine P Rankin, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of this study, masking is not possible. Participants and researchers must be aware of which arm they are in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups of 20 participants. Group 1 is the control arm (online, self-guided stress reduction course) and group 2 is the intervention arm (MBSR group.)

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: August 12, 2021
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)