Acceptance and Commitment Therapy for Family Caregivers of People With Dementia

Psychological Distress Clinical Trial

Official title:

Internet-based Acceptance and Commitment Therapy for Family Caregivers of People With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04458870
• Other study ID #: IRB-300005230
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: November 9, 2020

Study information

• Verified date: December 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The pilot project aims to investigate the feasibility and the preliminary efficacy of a guided online acceptance and commitment therapy (ACT) intervention for distressed family caregivers of people with dementia. A one-group pretest-posttest design (n=15) will be used to investigate the potential effects of the 10 weekly online ACT intervention session on caregivers' outcomes at posttest (10 weeks).

Description:

This project will employ one-group pretest-posttest design to investigate the potential impact of a guided online ACT intervention on improving quality of life and psychological health in distressed family caregivers of people with dementia. After the baseline evaluation, eligible caregivers will receive 10 weekly ACT sessions, individually delivered by a licensed professional counselor online. Each session lasts for one hour. Primary outcome measures will be psychological distress measured by the Depression, Anxiety and Stress Scale (DASS)- 21 and care-related quality of life measured by the Care-related Quality of Life instrument (CarerQol). A one-time interview at the completion of the 10 weekly sessions will be conducted to explore caregivers' experiences in the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 9, 2020
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. community-dwelling adults (age 18 or over) who are currently taking primary responsibility for the care of a relative with dementia living in the community

2. devoting at least 1 hour daily to the care of the relative with dementia

3. having cared for a relative with dementia for at least 3 months

4. suffering at least mild symptoms of psychological distress measured by the DASS-21 (scores = 5 on Depression Subscale of DASS-21, scores = 4 on Anxiety Subscale, or scores = 8 on Stress Subscale)

5. having a computer/smartphone with internet access capable of doing web browsing and video-conferencing

6. being able to provide informed consent by understanding the nature of study participation.

Exclusion Criteria:

1. having cognitive, physical, or sensory deficits, or language barriers (non-English communicator) that impede study participation

2. receiving a psychological therapy currently

3. having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years

4. taking antipsychotic or anticonvulsant medication at the time of recruitment

5. considering or planning to place family members of dementia in a nursing home within 6 months

6. 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).

Related Conditions & MeSH terms

• Dementia
• Psychological Distress

Intervention

Behavioral:
• Acceptance and Commitment Therapy
Participants will receive 10 weekly individual acceptance and commitment therapy by a trained coach through zoom video-conferencing.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cortisol levels by collecting fingernails	A biological measure of stress will be assessed through analysis of cortisol levels in caregivers' nail samples.	Change from baseline to 10 weeks
Other	System Usability Scale	The System Usability Scale (SUS) is a 10-item self-report questionnaire measuring usability of a program/intervention. Higher scores indicate greater levels of perceived usability of the intervention.	at 10 weeks
Primary	Depression, Anxiety and Stress Scale - 21	The Depression, Anxiety and Stress Scale (DASS)- 21 is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and stress. Higher scores represent greater symptomatology.	Change from baseline to 10 weeks
Primary	Care-related Quality of Life instrument	Care-related Quality of Life instrument (CarerQol) assesses the impact of providing informal care on caregivers and combines a 7-item subjective burden measure (CarerQol-7D) with well-being (CarerQol-VAS). Higher scores indicate higher levels of quality of life.	Change from baseline to 10 weeks
Secondary	Zarit Burden Interview	The Zarit Burden Interview (ZBI) is a 12-item self-report questionnaire assessing caregiver. Higher scores indicate higher levels of burden.	Change from baseline to 10 weeks
Secondary	Brief Coping Orientation to Problems Experienced	Brief COPE (Coping Orientation to Problems Experienced) is a 28-item self-report questionnaire measuring coping strategies in response to stressors. Three composite subscales include problem-focused, emotion-focused, and dysfunctional coping strategies. Higher scores on a subscale indicates more frequent use of the relevant coping strategies.	Change from baseline to 10 weeks
Secondary	Engagement in Meaningful Activities Survey	The Engagement in Meaningful Activities Survey (EMAS) is a 12-item self-assessment instrument that measures a person's subjective experience of the meaningfulness of everyday activities. Higher scores indicate greater levels of engagement in meaningful activities.	Change from baseline to 10 weeks
Secondary	Experiential Avoidance in Caregiving Questionnaire	The Experiential Avoidance in Caregiving Questionnaire (EACQ) is a 15-item self-report questionnaire measuring experiential avoidance in caregivers. Higher scores indicate greater levels of experiential avoidance.	Change from baseline to 10 weeks
Secondary	Acceptance and Action Questionnaire-II	The Action and Acceptance Questionnaire (AAQ)-II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility.	Change from baseline to 10 weeks
Secondary	Cognitive Fusion Questionnaire	The Cognitive Fusion Questionnaire (CFQ)-7 is a 7-item self-report questionnaire measuring cognitive fusion. Higher scores indicate greater levels of cognitive fusion.	Change from baseline to 10 weeks