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

NCT05043441 | Completed

• 1 other identifier: AARG-21-846868
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms

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 (1)

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

  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.

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

Secondary Outcomes (10)

• 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 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 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 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 Caregiver Guilt Questionnaire

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

Study Arms (2)

Acceptance and commitment therapy (ACT) group

EXPERIMENTAL

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

Behavioral: Acceptance and commitment therapy (ACT)

Psychoeducation control group

SHAM COMPARATOR

Care as usual with psychoeducation materials provided

Behavioral: Psychoeducation

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 10 weeks through Zoom videoconferencing with psychoeducation materials provided.

Acceptance and commitment therapy (ACT) group

Psychoeducation BEHAVIORAL

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

Psychoeducation 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Alzheimer's Association: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 40163859 DERIVED

MeSH Terms

Conditions

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

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Areum Han, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 14, 2021
• Study Start: March 21, 2022
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)