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Clinical Trials/NCT05043441
NCT05043441
Completed
Not Applicable

A Ten-Week Online Acceptance and Commitment Therapy Intervention Guided by a Coach for Family Caregivers of People With Dementia: A Randomized Controlled Trial

University of Alabama at Birmingham1 site in 1 country33 target enrollmentMarch 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
University of Alabama at Birmingham
Enrollment
33
Locations
1
Primary Endpoint
Change from baseline to immediately after the intervention and 3 month follow-up on the Patient Health Questionnaire-9
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 21, 2022
End Date
June 18, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Areum Han

Assistant professor

University of Alabama at Birmingham

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Change from baseline to immediately after the intervention and 3 month follow-up on the Patient Health Questionnaire-9

Time Frame: Change from baseline to immediately after the intervention and 3 month follow-up

The Patient Health Questionnaire-9 is a 9-item questionnaire assessing depressive symptoms on a scale of 0 to 3. Scores range from 0 to 27. Higher scores indicate greater symptomatology in depression.

Secondary Outcomes

  • Change from baseline to immediately after the intervention and 3 month follow-up on the Action and Acceptance Questionnaire-II(Change from baseline to immediately after the intervention and 3 month follow-up)
  • Change from baseline to immediately after the intervention and 3 month follow-up on the Perceived Stress Scale(Change from baseline to immediately after the intervention and 3 month follow-up)
  • Change from baseline to immediately after the intervention and 3 month follow-up on the Generalized Anxiety Disorder-7(Change from baseline to immediately after the intervention and 3 month follow-up)
  • Change from baseline to immediately after the intervention and 3 month follow-up on the Meuser Caregiver Grief Inventory(Change from baseline to immediately after the intervention and 3 month follow-up)
  • Change from baseline to immediately after the intervention and 3 month follow-up on the Cognitive Fusion Questionnaire(Change from baseline to immediately after the intervention and 3 month follow-up)
  • Change from baseline to immediately after the intervention and 3 month follow-up on the World Health Organization Quality of Life - Psychological health component(Change from baseline to immediately after the intervention and 3 month follow-up)
  • Change from baseline to immediately after the intervention and 3 month follow-up on the Self-Compassion Scale- Short Form(Change from baseline to immediately after the intervention and 3 month follow-up)
  • Change from baseline to immediately after the intervention and 3-month follow-up on the Engaged Living Scale(Change from baseline to immediately after the intervention and 3 month follow-up)
  • Change from baseline to immediately after the intervention and 3 month follow-up on the Caregiver Guilt Questionnaire(Change from baseline to immediately after the intervention and 3 month follow-up)
  • Change from baseline to immediately after the intervention and 3 month follow-up on the Zarit Burden Interview(Change from baseline to immediately after the intervention and 3 month follow-up)

Study Sites (1)

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