Clinical Trials Directory

Trials / Completed

CompletedNCT04847986

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

A Guided Eight-week Online Acceptance and Commitment Therapy (ACT) Intervention for Distressed Family Caregivers of People With Dementia: A Mixed-methods Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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

Interventions

TypeNameDescription
BEHAVIORALacceptance 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.
BEHAVIORALControl groupThe control group will receive care as usual with psychoeducation materials provided.

Timeline

Start date
2021-07-19
Primary completion
2022-06-22
Completion
2022-06-22
First posted
2021-04-19
Last updated
2022-06-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04847986. Inclusion in this directory is not an endorsement.