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Acceptance and Commitment Therapy for Family Caregivers of People With Dementia

Primary Purpose

Psychological Distress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Distress focused on measuring Caregivers, Dementia, Alzheimer's Disease, Burden, Quality of life, Acceptance and Commitment Therapy, Mindfulness, Psychological health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acceptance and Commitment Therapy

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Zarit Burden Interview
The Zarit Burden Interview (ZBI) is a 12-item self-report questionnaire assessing caregiver. Higher scores indicate higher levels of burden.
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.
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.
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.
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.
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.

Full Information

First Posted
June 26, 2020
Last Updated
December 8, 2020
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04458870
Brief Title
Acceptance and Commitment Therapy for Family Caregivers of People With Dementia
Official Title
Internet-based Acceptance and Commitment Therapy for Family Caregivers of People With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
November 9, 2020 (Actual)
Study Completion Date
November 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Distress
Keywords
Caregivers, Dementia, Alzheimer's Disease, Burden, Quality of life, Acceptance and Commitment Therapy, Mindfulness, Psychological health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and Commitment Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
Participants will receive 10 weekly individual acceptance and commitment therapy by a trained coach through zoom video-conferencing.
Primary Outcome Measure Information:
Title
Depression, Anxiety and Stress Scale - 21
Description
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.
Time Frame
Change from baseline to 10 weeks
Title
Care-related Quality of Life instrument
Description
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.
Time Frame
Change from baseline to 10 weeks
Secondary Outcome Measure Information:
Title
Zarit Burden Interview
Description
The Zarit Burden Interview (ZBI) is a 12-item self-report questionnaire assessing caregiver. Higher scores indicate higher levels of burden.
Time Frame
Change from baseline to 10 weeks
Title
Brief Coping Orientation to Problems Experienced
Description
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.
Time Frame
Change from baseline to 10 weeks
Title
Engagement in Meaningful Activities Survey
Description
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.
Time Frame
Change from baseline to 10 weeks
Title
Experiential Avoidance in Caregiving Questionnaire
Description
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.
Time Frame
Change from baseline to 10 weeks
Title
Acceptance and Action Questionnaire-II
Description
The Action and Acceptance Questionnaire (AAQ)-II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility.
Time Frame
Change from baseline to 10 weeks
Title
Cognitive Fusion Questionnaire
Description
The Cognitive Fusion Questionnaire (CFQ)-7 is a 7-item self-report questionnaire measuring cognitive fusion. Higher scores indicate greater levels of cognitive fusion.
Time Frame
Change from baseline to 10 weeks
Other Pre-specified Outcome Measures:
Title
Cortisol levels by collecting fingernails
Description
A biological measure of stress will be assessed through analysis of cortisol levels in caregivers' nail samples.
Time Frame
Change from baseline to 10 weeks
Title
System Usability Scale
Description
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.
Time Frame
at 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 devoting at least 1 hour daily to the care of the relative with dementia having cared for a relative with dementia for at least 3 months 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) having a computer/smartphone with internet access capable of doing web browsing and video-conferencing being able to provide informed consent by understanding the nature of study participation. Exclusion Criteria: having cognitive, physical, or sensory deficits, or language barriers (non-English communicator) that impede study participation receiving a psychological therapy currently having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years taking antipsychotic or anticonvulsant medication at the time of recruitment considering or planning to place family members of dementia in a nursing home within 6 months 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Areum Han, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Acceptance and Commitment Therapy for Family Caregivers of People With Dementia

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