DepressionNCT05518968
Videoconferencing Acceptance and Commitment Therapy With a Web App Use for Family Caregivers of People With Dementia
A study testing Acceptance and commitment therapy in people with Depression, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the pilot study is to assess the effects of an 8-week program on improving mental health in depressed family caregivers of people with dementia. The program will involve 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy (ACT) for 8… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Acceptance and commitment therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 1 Jan 2027
- 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
- having at least mild depression as measured by the Patient Health Questionnaire (PHQ)-9
- having a web-enabled device (e.g., a smartphone, a tablet, or a laptop/desktop) with the internet access at home
Who cannot join
- having cognitive, physical, or sensory deficits or language barriers (non-English communicator) that might impede study participation
- receiving a psychological therapy at the time of recruitment
- having a prior experience in acceptance and commitment therapy
- having psychiatric hospitalizations in the previous two years
- considering or planning to place relatives with dementia in a nursing home within 3 months
- recent frequent hospitalizations of their relatives with dementia that might contribute to study dropout
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: An Eight-week Program for Family Caregivers of People With Dementia Involving Coach-guided Videoconferencing Sessions With the Use of a Web App Based on Acceptance and Commitment Therapy: A Pilot Study
The purpose of the pilot study is to assess the effects of an 8-week program on improving mental health in depressed family caregivers of people with dementia. The program will involve 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy (ACT) for 8 weeks. Also, the study aims to understand these caregivers' experiences in the program, including their perspectives on the app features and contents. We aim to recruit 8-10 people for this pilot project. Outcomes regarding caregivers' mental health and ACT processes will be collected at pretest and posttest (after the completion of the 8-week program) and compared over time (i.e., posttest scores compared to pretest). At posttest, acceptability and perceived usability of the app will be evaluated using the 10-item System Usability Scale and 30-40 minute individual interviews.
Read the detailed description
The purpose of the pilot study is to assess the effects of an 8-week program on improving mental health in depressed family caregivers of people with dementia. The program will involve 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy (ACT) for 8 weeks. Also, the study aims to understand these caregivers' experiences in the program, including their perspectives on the app features and contents. We aim to recruit 8-10 people for this pilot project. Outcomes regarding caregivers' mental health and ACT processes will be collected at pretest and posttest (after the completion of the 8-week program) and compared over time (i.e., posttest scores compared to pretest). At posttest, acceptability and perceived usability of the app will be evaluated using the 10-item System Usability Scale and 30-40 minute individual interviews. Participants' characteristics will be summarized using descriptive statistics. Either the Wilcoxon signed-rank test (a non-parametric test) or the paired sample t-test (a parametric test) will be performed to test the exploratory hypothesis that participants' scores for the outcome measures would significantly improve at posttest compared to pretest. Because of the exploratory nature of the study, no adjustment of p values will be conducted for multiple statistical comparisons of the outcome measures. Statistical significance will be set at p <.05, and the effect sizes derived from this pilot study will form a basis for determining a sample size with sufficient statistical power required for a subsequent clinical trial. Caregivers' experiences in the app use and perspectives on the developed app will be explored using individual Zoom interviews. Interpretative phenomenological analysis will be used to analyze the interview data.
- Conditions
- Depression
- Being tested
- Acceptance and commitment therapy
- Keywords
- Acceptance and Commitment Therapy, Alzheimer's Disease, Burden, Caregivers, Dementia, Mindfulness, Self-compassion, Stress, Anxiety, Guilt, Grief, Telemedicine
- Medical subject headings
- Depression, Alzheimer Disease, Dementia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapyBehavioural
8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy Receives: Behavioral: Acceptance and commitment therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to immediately after the 8-week intervention on the Patient Health Questionnaire-9
The Patient Health Questionnaire-9 is a 9-item questionnaire assessing depressive symptoms on a scale of 0 to 3. Scores range from 0 to 27. Higher scores indicate greater symptomatology in depression.
Measured: Change from baseline to immediately after the 8-week intervention
Secondary outcomes (11)
Change from baseline to immediately after the 8-week intervention on the Generalized Anxiety Disorder-7
The Generalized Anxiety Disorder-7 is a 7-item questionnaire assessing anxiety on a scale of 0 to 3. Scores range from 0 to 21. Higher scores indicate greater anxiety.
Measured: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Perceived Stress Scale
The Perceived Stress Scale is a 10-item questionnaire assessing stress on a scale of 0 to 4. Scores range from 0 to 40. Higher scores indicate greater stress.
Measured: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the World Health Organization Quality of Life - Psychological health component
World Health Organization Quality of Life - Psychological health component has 6 items measuring psychological quality of life on scale of 1 to 5. Scores range from 6 to 30. Higher scores denote higher quality of life in terms of psychological health.
Measured: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention 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 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Marwit-Meuser Caregiver Grief Inventory Brief-Form
Marwit-Meuser Caregiver Grief Inventory Brief-Form is a 6-item self-report questionnaire assessing grief of caregivers on a scale of 1 to 5. Scores range from 6 to 30. Higher scores indicate higher levels of grief.
Measured: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Caregiver Guilt Questionnaire
Caregiver Guilt Questionnaire is a 22-item self-report questionnaire assessing feelings of guilt in caregivers on a scale of 0 to 4. Scores range from 0 to 88. Higher scores indicate higher levels of guilt.
Measured: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Self-Compassion Scale-Short Form
Self-Compassion Scale- Short Form is a 12-item self-report questionnaire assessing self-compassion on a scale of 1 to 5. Scores range from 12 to 60. Higher scores indicate higher levels of self-compassion.
Measured: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Action and Acceptance Questionnaire-II
Action and Acceptance Questionnaire -II is a 7-item self-report questionnaire measuring psychological flexibility on a scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate poor psychological flexibility.
Measured: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Cognitive Fusion Questionnaire
Cognitive Fusion Questionnaire -7 is a 7-item self-report questionnaire measuring cognitive fusion on scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate greater levels of cognitive fusion.
Measured: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Engaged Living Scale
Engaged Living Scale -9 is a 9-item self-assessment instrument that measures clarity and engagement with personal values and life fulfillment on a scale of 1 to 5. The total scores range from 9 to 45, and higher scores indicate increased clarity and engagement with personal values and greater life fulfillment.
Measured: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Five Facet Mindfulness Questionnaire
Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-assessment instrument that measures five aspects of mindfulness (i.e., observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience) on a scale of 1 to 5. The total scores range from 39 to 195, and higher scores indicate greater mindfulness.
Measured: Change from baseline to immediately after the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Why it stopped: We changed our plan.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- 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
- NCT05518968
- Sponsor's protocol ID
- IRB-300009858
- Status last verified
- Jan 2024
- First submitted
- 25 Aug 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-week Program for Family Caregivers of People With Dementia Involving Coach-guided Videoconferencing Sessions With the Use of a Web App Based on Acceptance and Commitment Therapy: A Pilot Study
- ClinicalTrials.gov ID
- NCT05518968
- Acronym / sponsor ID
- IRB-300009858
- Conditions
- Depression
- Keywords
- Acceptance and Commitment Therapy, Alzheimer's Disease, Burden, Caregivers, Dementia, Mindfulness, Self-compassion, Stress
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We changed our plan.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 Aug 2022 (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 purpose of the pilot study is to assess the effects of an 8-week program on improving mental health in depressed family caregivers of people with dementia. The program will involve 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy (ACT) for 8 weeks. Also, the study aims to understand these caregivers' experiences in the program, including their perspectives on the app features and contents. We aim to recruit 8-10 people for this pilot project. Outcomes regarding caregivers' mental health and ACT processes will be collected at pretest and posttest (after the completion of the 8-week program) and compared over time (i.e., posttest scores compared to pretest). At posttest, acceptability and perceived usability of the app will be evaluated using the 10-item System Usability Scale and 30-40 minute individual interviews.
Detailed description
The purpose of the pilot study is to assess the effects of an 8-week program on improving mental health in depressed family caregivers of people with dementia. The program will involve 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy (ACT) for 8 weeks. Also, the study aims to understand these caregivers' experiences in the program, including their perspectives on the app features and contents. We aim to recruit 8-10 people for this pilot project. Outcomes regarding caregivers' mental health and ACT processes will be collected at pretest and posttest (after the completion of the 8-week program) and compared over time (i.e., posttest scores compared to pretest). At posttest, acceptability and perceived usability of the app will be evaluated using the 10-item System Usability Scale and 30-40 minute individual interviews. Participants' characteristics will be summarized using descriptive statistics. Either the Wilcoxon signed-rank test (a non-parametric test) or the paired sample t-test (a parametric test) will be performed to test the exploratory hypothesis that participants' scores for the outcome measures would significantly improve at posttest compared to pretest. Because of the exploratory nature of the study, no adjustment of p values will be conducted for multiple statistical comparisons of the outcome measures. Statistical significance will be set at p <.05, and the effect sizes derived from this pilot study will form a basis for determining a sample size with sufficient statistical power required for a subsequent clinical trial. Caregivers' experiences in the app use and perspectives on the developed app will be explored using individual Zoom interviews. Interpretative phenomenological analysis will be used to analyze the interview data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and commitment therapy8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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
- having at least mild depression as measured by the Patient Health Questionnaire (PHQ)-9
- having a web-enabled device (e.g., a smartphone, a tablet, or a laptop/desktop) with the internet access at home
Key exclusion criteria (6 listed)
- having cognitive, physical, or sensory deficits or language barriers (non-English communicator) that might impede study participation
- receiving a psychological therapy at the time of recruitment
- having a prior experience in acceptance and commitment therapy
- having psychiatric hospitalizations in the previous two years
- considering or planning to place relatives with dementia in a nursing home within 3 months
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 therapy8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy | Behavioural | Acceptance and Commitment Therapy |
Primary outcome
Change from baseline to immediately after the 8-week intervention on the Patient Health Questionnaire-9
Time frame: Change from baseline to immediately after the 8-week intervention
The Patient Health Questionnaire-9 is a 9-item questionnaire assessing depressive symptoms on a scale of 0 to 3. Scores range from 0 to 27. Higher scores indicate greater symptomatology in depression.
11 secondary outcomes
Change from baseline to immediately after the 8-week intervention on the Generalized Anxiety Disorder-7
Time frame: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Perceived Stress Scale
Time frame: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the World Health Organization Quality of Life - Psychological health component
Time frame: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Zarit Burden Interview
Time frame: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Marwit-Meuser Caregiver Grief Inventory Brief-Form
Time frame: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Caregiver Guilt Questionnaire
Time frame: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Self-Compassion Scale-Short Form
Time frame: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Action and Acceptance Questionnaire-II
Time frame: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Cognitive Fusion Questionnaire
Time frame: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Engaged Living Scale
Time frame: Change from baseline to immediately after the 8-week intervention
Change from baseline to immediately after the 8-week intervention on the Five Facet Mindfulness Questionnaire
Time frame: Change from baseline to immediately after the 8-week intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- 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 in people with Depression, 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 5 Jan 2024. 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. 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 was withdrawn before enrolling participants, so there are no results.
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 8-week intervention on the Patient Health Questionnaire-9 (time frame: Change from baseline to immediately after the 8-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.