A Ten-Week Online Acceptance and Commitment Therapy Intervention for Family Caregivers of People With Dementia

NCT ID: NCT05043441

Last Updated: 2024-10-09

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2024-06-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomized controlled trial aims to assess the effects of a coach-guided ten-week videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes in depressed family caregivers of people with dementia (PwD) compared to the control group. A total of 32 family caregivers of PwD who meet the eligibility criteria will be recruited and randomized to either the intervention group or the control group. The hypotheses are that the ACT group will show improvements in depressive symptoms, other mental health outcomes, and ACT process measures at posttest and 3-month follow-up, compared to the control group.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This randomized controlled trial aims to assess the effects of a coach-guided ten-week videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes in depressed family caregivers of people with dementia (PwD) compared to the control group. A total of 32 family caregivers of PwD who meet the eligibility criteria will be recruited and randomized to either the intervention group or the control group. Caregivers randomly assigned to the intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 10 weeks through Zoom videoconferencing with supplemental psychoeducation materials provided. Caregivers randomly assigned to the control group will receive care as usual with psychoeducation materials provided during the study period. Outcomes regarding caregivers' mental health and ACT processes will be collected at three time points (i.e., pretest, posttest, and 3-month follow-up) and compared between groups over time. The hypotheses are that the ACT group will show improvements in depressive symptoms, other mental health outcomes, and ACT process measures at posttest and 3-month follow-up, compared to the control group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Symptoms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acceptance and commitment therapy (ACT) group

10 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 10 weeks through Zoom videoconferencing with psychoeducation materials provided.

Psychoeducation control group

Care as usual with psychoeducation materials provided

Group Type SHAM_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 10 weeks through Zoom videoconferencing with psychoeducation materials provided.

Intervention Type BEHAVIORAL

Psychoeducation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* having at least mild depression as measured by the Patient Health Questionnaire (PHQ)-9
* 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
* 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 6 months or
* having the possibility of study dropouts due to medical conditions of caregivers (e.g., surgery that may affect mental health) and their relatives 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

Meet the organizations funding or collaborating on the study and learn about their roles.

Alzheimer's Association

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Areum Han

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Areum Han, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Han A, Oster R, Yuen H, Jenkins J, Hawkins J, Edwards L. Videoconference-Delivered Acceptance and Commitment Therapy for Family Caregivers of People With Dementia: Pilot Randomized Controlled Trial. JMIR Form Res. 2025 Mar 31;9:e67545. doi: 10.2196/67545.

Reference Type DERIVED
PMID: 40163859 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AARG-21-846868

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Reducing Depression in Dementia Caregivers
NCT00056316 COMPLETED PHASE1/PHASE2
Rural Dementia Caregiver Project
NCT04428112 COMPLETED NA
Caregiver Bootcamp
NCT07006116 RECRUITING NA