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Guided Eight-week Online Acceptance and Commitment Therapy for Distressed 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 (ACT)
Control group
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 Acceptance and Commitment Therapy, Alzheimer's Disease, Burden, Caregivers, Dementia, Mindfulness, Psychological health, Quality of life, Self-compassion, Stress, Depression, Anxiety, Guilt, Grief

Eligibility Criteria

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

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
  • devoting at least four hours daily to the care of the relative with dementia
  • having at least mild symptoms of psychological distress as measured by the Depression, Anxiety and Stress Scale (DASS-21; Antony et al., 1988)
  • 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
  • currently receiving a psychological therapy
  • having a prior experience in ACT
  • 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 four months or
  • 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 2

Arm Type

Experimental

Sham Comparator

Arm Label

acceptance and commitment therapy (ACT) group

Control group

Arm Description

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

care as usual with psychoeducation materials provided

Outcomes

Primary Outcome Measures

Change from baseline to immediately after the intervention and 1 month follow-up on the Depression, Anxiety and Stress Scale
Depression, Anxiety and Stress Scale - 21 is a 21-item questionnaire assessing depressive symptoms, anxiety, and stress over the past 7 days on a scale of 0 to 3. Scores on the individual subscales range from 0 to 21. Higher scores indicate greater symptomatology in each subscale of depressive symptoms (7 items), anxiety (7 items), and stress (7 items).
Change from baseline to immediately after the intervention and 1 month follow-up on the Zarit Burden Interview
Zarit Burden Interview is a 12-item self-report questionnaire assessing caregiver burden on a scale of 0 to 4. Higher scores indicate higher levels of burden. The total scores range from 0 to 48, and scores of 17 or greater indicate severe/high burden.

Secondary Outcome Measures

Change from baseline to immediately after the intervention and 1 month follow-up on the World Health Organization Quality of Life-BREF - Psychological health component
World Health Organization Quality of Life-BREF - Psychological health component has 6 items measuring psychological quality of life. Higher scores denote higher quality of life in terms of psychological health.
Change from baseline to immediately after the intervention and 1 month follow-up on the Meuser Caregiver Grief Inventory
Marwit-Meuser Caregiver Grief Inventory Brief-Form is a 6-item self-report questionnaire assessing grief of caregivers. Higher scores indicate higher levels of grief.
Change from baseline to immediately after the intervention and 1 month follow-up on the Caregiver Guilt Questionnaire
Caregiver Guilt Questionnaire is a 22-item self-report questionnaire assessing feelings of guilt in caregivers. Higher scores indicate higher levels of guilt.
Change from baseline to immediately after the intervention and 1 month follow-up on the Self-Compassion Scale- Short Form
Self-Compassion Scale- Short Form is a 12-item self-report questionnaire assessing self-compassion. Higher scores indicate higher levels of self-compassion.
Change from baseline to immediately after the intervention and 1 month follow-up on the Action and Acceptance Questionnaire-II
Action and Acceptance Questionnaire -II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility.
Change from baseline to immediately after the intervention and 1 month follow-up on the Cognitive Fusion Questionnaire
Cognitive Fusion Questionnaire -7 is a 7-item self-report questionnaire measuring cognitive fusion. Higher scores indicate greater levels of cognitive fusion.
Change from baseline to immediately after the intervention and 1 month follow-up on the Engagement in Meaningful Activities Survey
Engagement in Meaningful Activities Survey is a 12-item self-assessment instrument that measures a person's subjective experience of the meaningfulness of everyday activities. The total scores range from 12 to 48, and higher scores indicate greater levels of engagement in meaningful activities.

Full Information

First Posted
April 8, 2021
Last Updated
June 27, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
American Occupational Therapy Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04847986
Brief Title
Guided Eight-week Online Acceptance and Commitment Therapy for Distressed Family Caregivers of People With Dementia
Official Title
A Guided Eight-week Online Acceptance and Commitment Therapy (ACT) Intervention for Distressed Family Caregivers of People With Dementia: A Mixed-methods Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
June 22, 2022 (Actual)
Study Completion Date
June 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
American Occupational Therapy Foundation

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Distress
Keywords
Acceptance and Commitment Therapy, Alzheimer's Disease, Burden, Caregivers, Dementia, Mindfulness, Psychological health, Quality of life, Self-compassion, Stress, Depression, Anxiety, Guilt, Grief

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acceptance and commitment therapy (ACT) group
Arm Type
Experimental
Arm Description
8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
care as usual with psychoeducation materials provided
Intervention Type
Behavioral
Intervention Name(s)
acceptance and commitment therapy (ACT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
The control group will receive care as usual with psychoeducation materials provided.
Primary Outcome Measure Information:
Title
Change from baseline to immediately after the intervention and 1 month follow-up on the Depression, Anxiety and Stress Scale
Description
Depression, Anxiety and Stress Scale - 21 is a 21-item questionnaire assessing depressive symptoms, anxiety, and stress over the past 7 days on a scale of 0 to 3. Scores on the individual subscales range from 0 to 21. Higher scores indicate greater symptomatology in each subscale of depressive symptoms (7 items), anxiety (7 items), and stress (7 items).
Time Frame
Change from baseline to immediately after the intervention and 1 month follow-up
Title
Change from baseline to immediately after the intervention and 1 month follow-up on the Zarit Burden Interview
Description
Zarit Burden Interview is a 12-item self-report questionnaire assessing caregiver burden on a scale of 0 to 4. Higher scores indicate higher levels of burden. The total scores range from 0 to 48, and scores of 17 or greater indicate severe/high burden.
Time Frame
Change from baseline to immediately after the intervention and 1 month follow-up
Secondary Outcome Measure Information:
Title
Change from baseline to immediately after the intervention and 1 month follow-up on the World Health Organization Quality of Life-BREF - Psychological health component
Description
World Health Organization Quality of Life-BREF - Psychological health component has 6 items measuring psychological quality of life. Higher scores denote higher quality of life in terms of psychological health.
Time Frame
Change from baseline to immediately after the intervention and 1 month follow-up
Title
Change from baseline to immediately after the intervention and 1 month follow-up on the Meuser Caregiver Grief Inventory
Description
Marwit-Meuser Caregiver Grief Inventory Brief-Form is a 6-item self-report questionnaire assessing grief of caregivers. Higher scores indicate higher levels of grief.
Time Frame
Change from baseline to immediately after the intervention and 1 month follow-up
Title
Change from baseline to immediately after the intervention and 1 month follow-up on the Caregiver Guilt Questionnaire
Description
Caregiver Guilt Questionnaire is a 22-item self-report questionnaire assessing feelings of guilt in caregivers. Higher scores indicate higher levels of guilt.
Time Frame
Change from baseline to immediately after the intervention and 1 month follow-up
Title
Change from baseline to immediately after the intervention and 1 month follow-up on the Self-Compassion Scale- Short Form
Description
Self-Compassion Scale- Short Form is a 12-item self-report questionnaire assessing self-compassion. Higher scores indicate higher levels of self-compassion.
Time Frame
Change from baseline to immediately after the intervention and 1 month follow-up
Title
Change from baseline to immediately after the intervention and 1 month follow-up on the Action and Acceptance Questionnaire-II
Description
Action and Acceptance Questionnaire -II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility.
Time Frame
Change from baseline to immediately after the intervention and 1 month follow-up
Title
Change from baseline to immediately after the intervention and 1 month follow-up on the Cognitive Fusion Questionnaire
Description
Cognitive Fusion Questionnaire -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 immediately after the intervention and 1 month follow-up
Title
Change from baseline to immediately after the intervention and 1 month follow-up on the Engagement in Meaningful Activities Survey
Description
Engagement in Meaningful Activities Survey is a 12-item self-assessment instrument that measures a person's subjective experience of the meaningfulness of everyday activities. The total scores range from 12 to 48, and higher scores indicate greater levels of engagement in meaningful activities.
Time Frame
Change from baseline to immediately after the intervention and 1 month follow-up
Other Pre-specified Outcome Measures:
Title
System Usability Scale
Description
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
immediately after the intervention
Title
Interviews of participants
Description
Caregivers' experiences in the ACT intervention will be explored using individual interviews at posttest. As part of the pretest assessment, we will also explore perceived impacts of COVID-19 on daily lives of family caregivers of people with dementia through individual interviews. Each interview will last for about 30 minutes.
Time Frame
at baseline and immediately after the intervention

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 the primary responsibility for the care of a relative with dementia living in the community devoting at least four hours daily to the care of the relative with dementia having at least mild symptoms of psychological distress as measured by the Depression, Anxiety and Stress Scale (DASS-21; Antony et al., 1988) 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 currently receiving a psychological therapy having a prior experience in ACT 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 four months or 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

Learn more about this trial

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

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