NCT03857308

Brief Summary

This research study seeks to understand how stress reduction training influences caregiver well-being, sleep, and physiological responses to stress. All participants are caregivers of persons with dementia. Participants will complete a 14-day, online stress-reduction intervention which involves approximately 25-30 minutes of daily practice.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

November 13, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

January 7, 2019

Last Update Submit

April 22, 2020

Conditions

CaregiversBurnoutSleep

Keywords

well-beingsleepcaregiver

Outcome Measures

Primary Outcomes (3)

  • Change in Eudaimonic well-being

    54 item self-reported scale assessing change in eudaimonic well-being from pre to post-intervention. Will be assessed using the Scales of Psychologica Well-being (SPWB; Ryff \& Keyes, 1995) 1 = strongly disagree, 6 = strongly agree. This scale range applies for the 6 subscales, which can stand-alone, or be summed to obtain a total Eudaimonic Well-Being score. For this study, we are primarily interested in investigated changes over time of the summed score for eudaimonic well-being. Higher scores indicate higher eudaimonic well-being.

    Baseline to 2-weeks (post-intervention), and 3-month follow-up

  • Change in Sleep Quality

    We will use a sleep diary that involves self-reported sleep habits, which we will use to calculate sleep onset, wake after sleep onset, and sleep efficiency. This will allow us to understand any changes in overall sleep quality across the intervention.

    Baseline to 2-weeks (post-intervention), and 3-month follow-up

  • Change in Sleep Quality: Actigraph

    Actigraphic measure of limb movements used to calculate sleep efficiency, which is an assessment of the quality of sleep participants have.

    Baseline to 2-weeks (post-intervention), and 3-month follow-up

Secondary Outcomes (1)

  • Change in Relationship Quality

    Baseline to 2-weeks (post-intervention), and 3-month follow-up

Study Arms (2)

Mindfulness Training

EXPERIMENTAL
Behavioral: Mindfulness Training

Reappraisal Training

ACTIVE COMPARATOR
Behavioral: Reappraisal Training

Interventions

Mindfulness TrainingBEHAVIORAL

This stress reduction training will last 14 days and teach participants skills in concentration, monitoring of present-moment bodily experience, and acceptance of experience. Participants are encouraged to "mentally welcome" all physical and emotional experience. Each day will consist of approximately 25 to 30 minutes of training. A full explanation of the mindfulness training compared to the reappraisal training could interfere with study blinding procedures. A complete description can be provided after data collection is complete.

Mindfulness Training
Reappraisal TrainingBEHAVIORAL

This stress reduction training will last 14-days. Each day consists of 25 to 30 minutes of daily practice in "Coping control." Participants are encouraged to reframe and reappraise life events, both past and present, and encouraged to solve personal problems through active change. A full explanation of the reappraisal stress reduction program compared to the mindfulness program could interfere with study blinding procedures. A complete description can be provided after data collection is complete.

Also known as: My Time
Reappraisal Training

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • Self-reporting informal caregivers of persons with dementia

You may not qualify if:

  • Self-reported major depressive disorder with psychotic features
  • History of schizophrenia
  • Bipolar disorder
  • Uncorrected severe sensory impairments or chronic debilitating health problems that could hinder participating in the interventions
  • Previous MBSR training or regular meditative practice within previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Joseph Dzierzewski, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

February 27, 2019

Study Start

November 13, 2019

Primary Completion

March 25, 2020

Study Completion

March 25, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

US(1)