Acceptance and Commitment Therapy for Family Caregivers of People With Dementia

NCT04458870 | Completed

• 1 other identifier: IRB-300005230
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Psychological Distress

Keywords

Caregivers; Dementia; Alzheimer's Disease; Burden; Quality of life; Acceptance and Commitment Therapy; Mindfulness; Psychological health

Outcome Measures

Primary Outcomes (2)

• Depression, Anxiety and Stress Scale - 21

  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.

  Change from baseline to 10 weeks

• Care-related Quality of Life instrument

  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.

  Change from baseline to 10 weeks

Secondary Outcomes (6)

• Zarit Burden Interview

  Change from baseline to 10 weeks

• Brief Coping Orientation to Problems Experienced

  Change from baseline to 10 weeks

• Engagement in Meaningful Activities Survey

  Change from baseline to 10 weeks

• Experiential Avoidance in Caregiving Questionnaire

  Change from baseline to 10 weeks

• Acceptance and Action Questionnaire-II

  Change from baseline to 10 weeks

Other Outcomes (2)

• Cortisol levels by collecting fingernails

  Change from baseline to 10 weeks

• System Usability Scale

  at 10 weeks

Study Arms (1)

Acceptance and Commitment Therapy

EXPERIMENTAL

Behavioral: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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

Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Psychological Well-Being

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Areum Han, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2020
• Primary Completion: November 9, 2020
• Study Completion: November 9, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)