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

NCT ID: NCT04847986

Last Updated: 2022-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-19

Study Completion Date

2022-06-22

Brief Summary

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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.

Detailed Description

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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. Caregivers assigned to the intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 8 weeks through Zoom videoconferencing with supplemental psychoeducation materials provided. Caregivers assigned to the control group will receive care as usual with psychoeducation materials provided. Outcomes regarding caregivers' mental health will be collected at three time points (i.e., pretest, posttest, and 1-month follow-up) and compared between groups over time. 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

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Psychological Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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acceptance and commitment therapy (ACT) group

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

Group Type EXPERIMENTAL

acceptance and commitment therapy (ACT)

Intervention Type 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.

Control group

care as usual with psychoeducation materials provided

Group Type SHAM_COMPARATOR

Control group

Intervention Type BEHAVIORAL

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

Interventions

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acceptance and commitment therapy (ACT)

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.

Intervention Type BEHAVIORAL

Control group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Occupational Therapy Foundation

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Areum Han

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Areum Han, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36591636 (View on PubMed)

Other Identifiers

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AOTFIRG21Han

Identifier Type: -

Identifier Source: org_study_id

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