Psychological DistressNCT04847986
Guided Eight-week Online Acceptance and Commitment Therapy for Distressed Family Caregivers of People With Dementia
A study testing acceptance and commitment therapy (ACT) in people with Psychological Distress, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress
- What is being tested?
- acceptance and commitment therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2021to 22 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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
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.
Read the 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.
- Conditions
- Psychological Distress
- Being tested
- acceptance and commitment therapy (ACT), Control group
- Keywords
- Acceptance and Commitment Therapy, Alzheimer's Disease, Burden, Caregivers, Dementia, Mindfulness, Psychological health, Quality of life, Self-compassion, Stress, Depression, Anxiety, Guilt, Grief
- Medical subject headings
- Alzheimer Disease, Dementia, Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acceptance and commitment therapy (ACT)Behavioural
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 groupBehavioural
The control group will receive care as usual with psychoeducation materials provided.
| Study group | Role | What they receive |
|---|---|---|
| acceptance and commitment therapy (ACT) group | Experimental | 8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided Receives: Behavioral: acceptance and commitment therapy (ACT) |
| Control group | Sham comparator | care as usual with psychoeducation materials provided Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline to immediately after the intervention and 1 month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 1 month follow-up
Secondary outcomes (7)
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.
Measured: Change from baseline to immediately after the intervention and 1 month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 1 month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 1 month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 1 month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 1 month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 1 month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start19 Jul 2021
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Principal investigator, Areum Han, University of Alabama at Birmingham
- Investigators
- Areum Han, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847986
- Sponsor's protocol ID
- AOTFIRG21Han
- Status last verified
- Jun 2022
- First submitted
- 8 Apr 2021
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han A, Yuen HK, Jenkins J. The feasibility and preliminary effects of a pilot randomized controlled trial: Videoconferencing acceptance and commitment therapy in distressed family caregivers of people with dementia. J Health Psychol. 2023 May;28(6):554-567. doi: 10.1177/13591053221141131. Epub 2023 Jan 2.
PubMed 36591636
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04847986
- Acronym / sponsor ID
- AOTFIRG21Han
- Conditions
- Psychological Distress
- Keywords
- Acceptance and Commitment Therapy, Alzheimer's Disease, Burden, Caregivers, Dementia, Mindfulness, Psychological health, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acceptance and commitment therapy (ACT) group | Experimental | Behavioral: acceptance and commitment therapy (ACT)8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided |
| Control group | Sham comparator | Behavioral: Control groupcare as usual with psychoeducation materials provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acceptance and commitment therapy (ACT)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. | Behavioural | acceptance and commitment therapy (ACT) group |
| Control groupThe control group will receive care as usual with psychoeducation materials provided. | Behavioural | Control group |
Primary outcome
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).
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.
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Derived from this study: PubMed 36591636Han A, Yuen HK, Jenkins J. The feasibility and preliminary effects of a pilot randomized controlled trial: Videoconferencing acceptance and commitment therapy in distressed family caregivers of people with dementia. J Health Psychol. 2023 May;28(6):554-567. doi: 10.1177/13591053221141131. Epub 2023 Jan 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Areum Han, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acceptance and commitment therapy (ACT) in people with Psychological Distress, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.