Guided Eight-week Online Acceptance and Commitment Therapy for Distressed Family Caregivers of People With Dementia

NCT04847986 | Completed

• 1 other identifier: AOTFIRG21Han
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The pilot randomized controlled trial aims to assess effects of a guided online acceptance and commitment therapy (ACT) intervention on distressed family caregivers of people with dementia (PwD) compared to the control group. A total of 24 family caregivers of PwD who meet the inclusion criteria will be recruited and randomized to either the intervention or control group. Exploratory hypotheses are that the ACT group will show decreases in caregivers' psychological distress and burden and improvements in QoL and engagement in meaningful activities at posttest and 1-month follow-up, compared to the control group. Also, the project will evaluate the feasibility of recruitment, adherence, and retention of caregivers and explore caregivers' experiences in the ACT intervention through semi-structured interviews at posttest. As part of the pretest, we will also explore caregivers' perceived impacts of COVID-19 on daily lives.

Conditions

Psychological Distress

Keywords

Acceptance and Commitment Therapy; Alzheimer's Disease; Burden; Caregivers; Dementia; Mindfulness; Psychological health; Quality of life; Self-compassion; Stress; Depression; Anxiety; Guilt; Grief

Outcome Measures

Primary Outcomes (2)

• Change from baseline to immediately after the intervention and 1 month follow-up on the Depression, Anxiety and Stress Scale

  Depression, Anxiety and Stress Scale - 21 is a 21-item questionnaire assessing depressive symptoms, anxiety, and stress over the past 7 days on a scale of 0 to 3. Scores on the individual subscales range from 0 to 21. Higher scores indicate greater symptomatology in each subscale of depressive symptoms (7 items), anxiety (7 items), and stress (7 items).

  Change from baseline to immediately after the intervention and 1 month follow-up

• Change from baseline to immediately after the intervention and 1 month follow-up on the Zarit Burden Interview

  Zarit Burden Interview is a 12-item self-report questionnaire assessing caregiver burden on a scale of 0 to 4. Higher scores indicate higher levels of burden. The total scores range from 0 to 48, and scores of 17 or greater indicate severe/high burden.

  Change from baseline to immediately after the intervention and 1 month follow-up

Secondary Outcomes (7)

• Change from baseline to immediately after the intervention and 1 month follow-up on the World Health Organization Quality of Life-BREF - Psychological health component

  Change from baseline to immediately after the intervention and 1 month follow-up

• Change from baseline to immediately after the intervention and 1 month follow-up on the Meuser Caregiver Grief Inventory

  Change from baseline to immediately after the intervention and 1 month follow-up

• Change from baseline to immediately after the intervention and 1 month follow-up on the Caregiver Guilt Questionnaire

  Change from baseline to immediately after the intervention and 1 month follow-up

• Change from baseline to immediately after the intervention and 1 month follow-up on the Self-Compassion Scale- Short Form

  Change from baseline to immediately after the intervention and 1 month follow-up

• Change from baseline to immediately after the intervention and 1 month follow-up on the Action and Acceptance Questionnaire-II

  Change from baseline to immediately after the intervention and 1 month follow-up

Other Outcomes (2)

• System Usability Scale

  immediately after the intervention

• Interviews of participants

  at baseline and immediately after the intervention

Study Arms (2)

acceptance and commitment therapy (ACT) group

EXPERIMENTAL

8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided

Behavioral: acceptance and commitment therapy (ACT)

Control group

SHAM COMPARATOR

care as usual with psychoeducation materials provided

Behavioral: Control group

Interventions

acceptance and commitment therapy (ACT) BEHAVIORAL

Caregivers assigned to this intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 8 weeks through Zoom videoconferencing with psychoeducation materials provided.

acceptance and commitment therapy (ACT) group

Control group BEHAVIORAL

The control group will receive care as usual with psychoeducation materials provided.

Control group

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 the primary responsibility for the care of a relative with dementia living in the community
• devoting at least four hours daily to the care of the relative with dementia
• having at least mild symptoms of psychological distress as measured by the Depression, Anxiety and Stress Scale (DASS-21; Antony et al., 1988)
• having a computer or a smartphone with the internet access at home and
• being able to provide informed consent.

You may not qualify if:

• having cognitive, physical, or sensory deficits or language barriers (non-English communicator) that impede study participation
• currently receiving a psychological therapy
• having a prior experience in ACT
• having psychiatric hospitalizations or diagnoses of mental illness in the previous two years
• taking antipsychotic or anticonvulsant medication at the time of recruitment
• considering or planning to place family members of PwD in a nursing home within four months or
• 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
• American Occupational Therapy Foundation: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Han A, Yuen HK, Jenkins J. The feasibility and preliminary effects of a pilot randomized controlled trial: Videoconferencing acceptance and commitment therapy in distressed family caregivers of people with dementia. J Health Psychol. 2023 May;28(6):554-567. doi: 10.1177/13591053221141131. Epub 2023 Jan 2.

  PMID: 36591636 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Psychological Well-Being; Depression; Anxiety Disorders

Interventions

Acceptance and Commitment Therapy; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Areum Han, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 19, 2021
• Study Start: July 19, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)