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Completed

NCT Number: NCT04458870

Acceptance and Commitment Therapy for Family Caregivers of People With Dementia

The pilot project aims to investigate the feasibility and the preliminary efficacy of a guided online acceptance and commitment therapy (ACT) intervention for distressed family caregivers of people with dementia. A one-group pretest-posttest design (n=15) will be used to investigate the potential effects of the 10 weekly online ACT intervention session on caregivers' outcomes at posttest (10 weeks).

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Key information

Conditions

Psychological Distress Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Personal Satisfaction Psychological Well-Being Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

This project will employ one-group pretest-posttest design to investigate the potential impact of a guided online ACT intervention on improving quality of life and psychological health in distressed family caregivers of people with dementia. After the baseline evaluation, eligible caregivers will receive 10 weekly ACT sessions, individually delivered by a licensed professional counselor online. Each session lasts for one hour. Primary outcome measures will be psychological distress measured by the Depression, Anxiety and Stress Scale (DASS)- 21 and care-related quality of life measured by the Care-related Quality of Life instrument (CarerQol). A one-time interview at the completion of the 10 weekly sessions will be conducted to explore caregivers' experiences in the intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • community-dwelling adults (age 18 or over) who are currently taking primary responsibility for the care of a relative with dementia living in the community
  • devoting at least 1 hour daily to the care of the relative with dementia
  • having cared for a relative with dementia for at least 3 months
  • suffering at least mild symptoms of psychological distress measured by the DASS-21 (scores ≥ 5 on Depression Subscale of DASS-21, scores ≥ 4 on Anxiety Subscale, or scores ≥ 8 on Stress Subscale)
  • having a computer/smartphone with internet access capable of doing web browsing and video-conferencing
  • being able to provide informed consent by understanding the nature of study participation.

Exclusion criteria

  • having cognitive, physical, or sensory deficits, or language barriers (non-English communicator) that impede study participation
  • receiving a psychological therapy currently
  • having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years
  • taking antipsychotic or anticonvulsant medication at the time of recruitment
  • considering or planning to place family members of dementia in a nursing home within 6 months
  • having the possibility of study dropouts due to other medical conditions of family members with dementia (e.g., conditions that may impede study participation due to frequent hospitalization or death).

Treatment and study plan

Acceptance and Commitment Therapy

Behavioral

Participants will receive 10 weekly individual acceptance and commitment therapy by a trained coach through zoom video-conferencing.

Primary outcomes

  1. Depression, Anxiety and Stress Scale - 21

    Time frame: Change from baseline to 10 weeks

    The Depression, Anxiety and Stress Scale (DASS)- 21 is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and stress. Higher scores represent greater symptomatology.

  2. Care-related Quality of Life instrument

    Time frame: Change from baseline to 10 weeks

    Care-related Quality of Life instrument (CarerQol) assesses the impact of providing informal care on caregivers and combines a 7-item subjective burden measure (CarerQol-7D) with well-being (CarerQol-VAS). Higher scores indicate higher levels of quality of life.

Secondary outcomes

  1. Zarit Burden Interview

    Time frame: Change from baseline to 10 weeks

    The Zarit Burden Interview (ZBI) is a 12-item self-report questionnaire assessing caregiver. Higher scores indicate higher levels of burden.

  2. Brief Coping Orientation to Problems Experienced

    Time frame: Change from baseline to 10 weeks

    Brief COPE (Coping Orientation to Problems Experienced) is a 28-item self-report questionnaire measuring coping strategies in response to stressors. Three composite subscales include problem-focused, emotion-focused, and dysfunctional coping strategies. Higher scores on a subscale indicates more frequent use of the relevant coping strategies.

  3. Engagement in Meaningful Activities Survey

    Time frame: Change from baseline to 10 weeks

    The Engagement in Meaningful Activities Survey (EMAS) is a 12-item self-assessment instrument that measures a person's subjective experience of the meaningfulness of everyday activities. Higher scores indicate greater levels of engagement in meaningful activities.

  4. Experiential Avoidance in Caregiving Questionnaire

    Time frame: Change from baseline to 10 weeks

    The Experiential Avoidance in Caregiving Questionnaire (EACQ) is a 15-item self-report questionnaire measuring experiential avoidance in caregivers. Higher scores indicate greater levels of experiential avoidance.

  5. Acceptance and Action Questionnaire-II

    Time frame: Change from baseline to 10 weeks

    The Action and Acceptance Questionnaire (AAQ)-II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility.

  6. Cognitive Fusion Questionnaire

    Time frame: Change from baseline to 10 weeks

    The Cognitive Fusion Questionnaire (CFQ)-7 is a 7-item self-report questionnaire measuring cognitive fusion. Higher scores indicate greater levels of cognitive fusion.

Other outcomes

  1. Cortisol levels by collecting fingernails

    Time frame: Change from baseline to 10 weeks

    A biological measure of stress will be assessed through analysis of cortisol levels in caregivers' nail samples.

  2. System Usability Scale

    Time frame: at 10 weeks

    The System Usability Scale (SUS) is a 10-item self-report questionnaire measuring usability of a program/intervention. Higher scores indicate greater levels of perceived usability of the intervention.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Internet-based Acceptance and Commitment Therapy for Family Caregivers of People With Dementia

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 7, 2020
Registry last updated
Dec 10, 2020

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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