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Completed

NCT Number: NCT04847986

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

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.

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Key information

Conditions

Psychological Distress Alzheimer Disease Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Depression Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Personal Satisfaction Psychological Well-Being Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 8 weeks through Zoom videoconferencing with psychoeducation materials provided.

Control Group

Behavioral

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

Primary outcomes

  1. Change from baseline to immediately after the intervention and 1 month follow-up on the Depression, Anxiety and Stress Scale

    Time frame: Change from baseline to immediately after the intervention and 1 month follow-up

    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).

  2. Change from baseline to immediately after the intervention and 1 month follow-up on the Zarit Burden Interview

    Time frame: Change from baseline to immediately after the intervention and 1 month follow-up

    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 outcomes

  1. 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

    Time frame: Change from baseline to immediately after the intervention and 1 month follow-up

    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.

  2. Change from baseline to immediately after the intervention and 1 month follow-up on the Meuser Caregiver Grief Inventory

    Time frame: Change from baseline to immediately after the intervention and 1 month follow-up

    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.

  3. Change from baseline to immediately after the intervention and 1 month follow-up on the Caregiver Guilt Questionnaire

    Time frame: Change from baseline to immediately after the intervention and 1 month follow-up

    Caregiver Guilt Questionnaire is a 22-item self-report questionnaire assessing feelings of guilt in caregivers. Higher scores indicate higher levels of guilt.

  4. Change from baseline to immediately after the intervention and 1 month follow-up on the Self-Compassion Scale- Short Form

    Time frame: Change from baseline to immediately after the intervention and 1 month follow-up

    Self-Compassion Scale- Short Form is a 12-item self-report questionnaire assessing self-compassion. Higher scores indicate higher levels of self-compassion.

  5. Change from baseline to immediately after the intervention and 1 month follow-up on the Action and Acceptance Questionnaire-II

    Time frame: Change from baseline to immediately after the intervention and 1 month follow-up

    Action and Acceptance Questionnaire -II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility.

  6. Change from baseline to immediately after the intervention and 1 month follow-up on the Cognitive Fusion Questionnaire

    Time frame: Change from baseline to immediately after the intervention and 1 month follow-up

    Cognitive Fusion Questionnaire -7 is a 7-item self-report questionnaire measuring cognitive fusion. Higher scores indicate greater levels of cognitive fusion.

  7. Change from baseline to immediately after the intervention and 1 month follow-up on the Engagement in Meaningful Activities Survey

    Time frame: Change from baseline to immediately after the intervention and 1 month follow-up

    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.

Other outcomes

  1. System Usability Scale

    Time frame: immediately after the intervention

    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.

  2. Interviews of participants

    Time frame: at baseline and immediately after the intervention

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • American Occupational Therapy Foundation

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2021
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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