DementiaNCT02690896
Caregiver Burden and Depression: Caring for Those Who Care for Others
A study testing UCF Caregiver Support Group and Community Support Groups in people with Dementia and Alzheimer's Disease, run by University of Central Florida at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of support group intervention for primary caregivers of a person with dementia or similar cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer's Disease
- What is being tested?
- UCF Caregiver Support Group and Community Support Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2016to 1 Aug 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants must be currently providing care to a demented or cognitively impaired adult
- All participants must live in the United States.
- Participants in the community comparison group must be currently enrolled in a caregiver support group in the community (i.e., not the UCF caregiver support group).
Who cannot join
- Participants who do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
The purpose of this study is to examine the effectiveness of support group intervention for primary caregivers of a person with dementia or similar cognitive impairment.
Read the detailed description
This research aims to determine if participation in caregiver support groups and individual differences between caregivers influence the decision of the caregiver to place their family member in a long-term care facility. This research also aims to identify significant predictor variables of outcome. The intervention to be employed has been empirically supported by past research (Gonyea, 2006), but additional research is required to establish this intervention as an empirically supported treatment for caregivers. The proposed research will examine the hypotheses that: (A) a brief 6-session caregiver support group will reduce caregiver burden and depression and delay or prevent transition to long-term care (e.g., nursing home care); and (B) specific caregiver characteristics will emerge as significant moderators of treatment outcomes.
The first activity of the proposed research will involve the advertisement of the caregiver support group. The caregiver support group advertisement will be posted in various facilities related to the care of older adults in the surrounding community and will also be distributed via email listserves. Next, individuals who are interested in the study and caregiver support group will contact the principal investigator or research assistants via the telephone number or email address listed on the advertisement. The proposed research utilizes a UCF behavioral intervention group and a community comparison group. The UCF behavioral intervention group will be based on the principles of behavior therapy and behavioral activation. Groups are designed to teach caregivers specific behavioral techniques for managing care recipients' symptoms in the home environment. The community comparison group will be a "treatment as usual" group; participants will be recruited from various established caregiver support groups in the community. The UCF behavioral intervention caregiver support groups will be highly structured and will be conducted with up to 13 members. The UCF behavioral intervention caregiver support groups will be run over the course of 6 weeks, with groups meeting once a week for 90 minutes. Groups will be scheduled at weekly intervals, as is characteristic for most psychotherapeutic support groups. The intake packet will include questions that are biological, psychological, and social in nature. Caregivers will also be asked questions related to their caregiving situation. Included in the packet are the following measures: demographic survey, ADL and IADL survey, caregiver preparedness scale, Center for Epidemiological Studies Short Depression Scale (CES-D 10), familial obligation scale, caregiver strain index, a neuropsychological symptom index, and a satisfaction survey. In addition, participants will completed at-home collection of saliva samples for measurement of stress hormone variation (cortisol). Saliva samples will be collected using oral swabs, which will be stored in number-coded tubes. Participants will record the time of day samples were collected, and provide subjective measures of psychological stress. Completed sample kits will be collected by study research assistants and brought back to th lab freezer for storage. This procedure will be repeated after the final session of the intervention. The group facilitator and co-faclitator will review the consent form with caregivers in person at the beginning of the first session. Participants who agree to take part in the caregiver support group and the proposed research will be given a copy of the consent form and will remain present for the current and subsequent sessions. If a participant is absent from a UCF behavioral intervention group session, he/she will be contacted by telephone and encouraged to attend future session as is consistent with standard clinic procedure. The investigators will not exclude a participant's data from analyses if he/she does not attend all six sessions.
Participants will be audio taped during this study. If a participant does not want to be audio taped, he/she will not be able to participate in the study and will be referred to an alternate provider if interested in receiving services elsewhere. The purpose of audio taping is to monitor consistency among the group sessions and to ensure treatment fidelity. The recordings will be reviewed only by principle investigator Dr. Paulson and the co-investigators, and will be deleted within two weeks of the recording. Audio recordings will be saved locally on an encrypted iPad used only for research purposes that is stored in a locked file cabinet in the OLDeR research lab, which requires code and card access.
Follow-up will be performed at 6 month intervals until the caregiving relationship has ended (if the caregiving relationship persists, follow-up will cease at 5 years).
For both the UCF behavioral intervention group and the community comparison group, participants will be contacted via telephone at 6 month intervals (after the termination of the 6-week support group for the UCF behavioral intervention group, and every 6 months following the termination of the first UCF behavioral intervention caregiver support group for community comparison participants).
The intended sample size for the proposed research includes 30 participants in the UCF behavioral intervention group and 30 participants in the community comparison group for a total of 60 participants.
Proposed statistical methods for data analyses include intent-to-treat (ITT) with last observation carried forward.
- Conditions
- Dementia, Alzheimer's Disease
- Being tested
- UCF Caregiver Support Group, Community Support Groups
- Keywords
- caregiver burden, caregiver support groups
- Medical subject headings
- Dementia, Alzheimer Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCF Caregiver Support GroupBehavioural
The intervention will be a 90 minute group session, once a week, for a period of 6 consecutive weeks. The intervention will teach caregivers specific behavioral techniques for managing care recipients' symptoms in the home environment and encourage caregiver self-care.
Community Support GroupsBehavioural
Comparison group members will come from local community support groups, which typically include components of social support and limited psychoeducation, and are relatively unstructured.
| Study group | Role | What they receive |
|---|---|---|
| UCF Behavioral Intervention Group | Experimental | The intervention group will be the UCF Caregiver Support. Participants will receive a 90 minute group session, once a week, for a period of 6 consecutive weeks. Receives: Behavioral: UCF Caregiver Support Group |
| Community Comparison Group | Active comparator | Comparison group members will come from potential local support groups include, but are not limited to, the support group at the Faith Assembly of God church, the caregiver support group at the First Baptist Church of Orlando, and the caregiver support group at the Alzheimer's and Dementia Resource Center. Receives: Behavioral: Community Support Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Long-Term Care Utilization based on Caregiver Report
Caregivers will be asked where there care recipient lives at baseline, and then their current living status thereafter to know if and when a transition to a long-term care facility occurs.
Measured: baseline, 6 weeks, and then every 6 months for 5 years
Secondary outcomes (9)
Neuropsychiatric symptoms
Caregivers will provide an assessment of their care recipient's neuropsychiatric functioning by completing the Neuropsychiatric Inventory.
Measured: baseline, 6 weeks, and then every 6 months for 5 years
Caregiver strain
Caregivers will provide an assessment of the burden associated with caregiving that they experience by completing The Caregiver Strain Index.
Measured: baseline, 6 weeks, and then every 6 months for 5 years
Caregiver depression
Caregiver depression will assessed by the Center for Epidemiologic Studies Short Depression Scale (CESD-10).
Measured: baseline, 6 weeks, and then every 6 months for 5 years
Caregiver preparedness
Caregivers will complete the The Preparedness for Caregiving Scale to assess how prepared they feel to perform the various aspects of caregiving.
Measured: baseline, 6 weeks, and then every 6 months for 5 years
Satisfaction Survey
Participants in the UCF Caregiver Support Group will also complete a group satisfaction survey during the last session (week 6) to determine how effective they felt the group intervention is.
Measured: at 6 weeks
Stress hormone level
Stress hormone level will be measured by cortisol levels obtained via saliva samples. Saliva samples will be collected via oral swabs for two consecutive days at both the morning and evening hours, at baseline and 6 weeks.
Measured: at baseline and 6 weeks
Daily stress inventory
Daily stress will be measured using the Daily Inventory of Stressful Events to assess subjective psychological stress experienced.
Measured: at baseline and 6 weeks
Subjective stress
The Pre-water Stress VAS will be used as another subjective measure of psychological stress experienced.
Measured: at baseline and 6 weeks
Emotional affective state
The Positive and Negative Affect Schedule (PANAS) will be used as another subjective measure of psychological stress experienced.
Measured: at baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study start24 Feb 2016
- Primary completion1 Aug 2018
- Study completion1 Aug 2020
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 DementiaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's and Dementia Resource Center
- Responsible party
- Principal investigator, Daniel Paulson, University of Central Florida
- Investigators
- Daniel L Paulson, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690896
- Sponsor's protocol ID
- SBE-15-11548
- Status last verified
- Jun 2021
- First submitted
- 11 Jan 2016
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gonyea JG, O'Connor MK, Boyle PA. Project CARE: a randomized controlled trial of a behavioral intervention group for Alzheimer's disease caregivers. Gerontologist. 2006 Dec;46(6):827-32. doi: 10.1093/geront/46.6.827.
PubMed 17169938
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Burden and Depression: Caring for Those Who Care for Others
- ClinicalTrials.gov ID
- NCT02690896
- Acronym / sponsor ID
- SBE-15-11548
- Conditions
- Dementia, Alzheimer's Disease
- Keywords
- caregiver burden, caregiver support groups
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- Alzheimer's and Dementia Resource Center
- Study start
- 24 Feb 2016 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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 this study is to examine the effectiveness of support group intervention for primary caregivers of a person with dementia or similar cognitive impairment.
Detailed description
This research aims to determine if participation in caregiver support groups and individual differences between caregivers influence the decision of the caregiver to place their family member in a long-term care facility. This research also aims to identify significant predictor variables of outcome. The intervention to be employed has been empirically supported by past research (Gonyea, 2006), but additional research is required to establish this intervention as an empirically supported treatment for caregivers. The proposed research will examine the hypotheses that: (A) a brief 6-session caregiver support group will reduce caregiver burden and depression and delay or prevent transition to long-term care (e.g., nursing home care); and (B) specific caregiver characteristics will emerge as significant moderators of treatment outcomes.
The first activity of the proposed research will involve the advertisement of the caregiver support group. The caregiver support group advertisement will be posted in various facilities related to the care of older adults in the surrounding community and will also be distributed via email listserves. Next, individuals who are interested in the study and caregiver support group will contact the principal investigator or research assistants via the telephone number or email address listed on the advertisement. The proposed research utilizes a UCF behavioral intervention group and a community comparison group. The UCF behavioral intervention group will be based on the principles of behavior therapy and behavioral activation. Groups are designed to teach caregivers specific behavioral techniques for managing care recipients' symptoms in the home environment. The community comparison group will be a "treatment as usual" group; participants will be recruited from various established caregiver support groups in the community. The UCF behavioral intervention caregiver support groups will be highly structured and will be conducted with up to 13 members. The UCF behavioral intervention caregiver support groups will be run over the course of 6 weeks, with groups meeting once a week for 90 minutes. Groups will be scheduled at weekly intervals, as is characteristic for most psychotherapeutic support groups. The intake packet will include questions that are biological, psychological, and social in nature. Caregivers will also be asked questions related to their caregiving situation. Included in the packet are the following measures: demographic survey, ADL and IADL survey, caregiver preparedness scale, Center for Epidemiological Studies Short Depression Scale (CES-D 10), familial obligation scale, caregiver strain index, a neuropsychological symptom index, and a satisfaction survey. In addition, participants will completed at-home collection of saliva samples for measurement of stress hormone variation (cortisol). Saliva samples will be collected using oral swabs, which will be stored in number-coded tubes. Participants will record the time of day samples were collected, and provide subjective measures of psychological stress. Completed sample kits will be collected by study research assistants and brought back to th lab freezer for storage. This procedure will be repeated after the final session of the intervention. The group facilitator and co-faclitator will review the consent form with caregivers in person at the beginning of the first session. Participants who agree to take part in the caregiver support group and the proposed research will be given a copy of the consent form and will remain present for the current and subsequent sessions. If a participant is absent from a UCF behavioral intervention group session, he/she will be contacted by telephone and encouraged to attend future session as is consistent with standard clinic procedure. The investigators will not exclude a participant's data from analyses if he/she does not attend all six sessions.
Participants will be audio taped during this study. If a participant does not want to be audio taped, he/she will not be able to participate in the study and will be referred to an alternate provider if interested in receiving services elsewhere. The purpose of audio taping is to monitor consistency among the group sessions and to ensure treatment fidelity. The recordings will be reviewed only by principle investigator Dr. Paulson and the co-investigators, and will be deleted within two weeks of the recording. Audio recordings will be saved locally on an encrypted iPad used only for research purposes that is stored in a locked file cabinet in the OLDeR research lab, which requires code and card access.
Follow-up will be performed at 6 month intervals until the caregiving relationship has ended (if the caregiving relationship persists, follow-up will cease at 5 years).
For both the UCF behavioral intervention group and the community comparison group, participants will be contacted via telephone at 6 month intervals (after the termination of the 6-week support group for the UCF behavioral intervention group, and every 6 months following the termination of the first UCF behavioral intervention caregiver support group for community comparison participants).
The intended sample size for the proposed research includes 30 participants in the UCF behavioral intervention group and 30 participants in the community comparison group for a total of 60 participants.
Proposed statistical methods for data analyses include intent-to-treat (ITT) with last observation carried forward.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCF Behavioral Intervention Group | Experimental | Behavioral: UCF Caregiver Support GroupThe intervention group will be the UCF Caregiver Support. Participants will receive a 90 minute group session, once a week, for a period of 6 consecutive weeks. |
| Community Comparison Group | Active comparator | Behavioral: Community Support GroupsComparison group members will come from potential local support groups include, but are not limited to, the support group at the Faith Assembly of God church, the caregiver support group at the First Baptist Church of Orlando, and the caregiver support group at the Alzheimer's and Dementia Resource Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All participants must be currently providing care to a demented or cognitively impaired adult
- All participants must live in the United States.
- Participants in the community comparison group must be currently enrolled in a caregiver support group in the community (i.e., not the UCF caregiver support group).
Key exclusion criteria (1 listed)
- Participants who do not speak English
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 |
|---|---|---|
| UCF Caregiver Support GroupThe intervention will be a 90 minute group session, once a week, for a period of 6 consecutive weeks. The intervention will teach caregivers specific behavioral techniques for managing care recipients' symptoms in the home environment and encourage caregiver self-care. | Behavioural | UCF Behavioral Intervention Group |
| Community Support GroupsComparison group members will come from local community support groups, which typically include components of social support and limited psychoeducation, and are relatively unstructured. | Behavioural | Community Comparison Group |
Primary outcome
Change in Long-Term Care Utilization based on Caregiver Report
Time frame: baseline, 6 weeks, and then every 6 months for 5 years
Caregivers will be asked where there care recipient lives at baseline, and then their current living status thereafter to know if and when a transition to a long-term care facility occurs.
9 secondary outcomes
Neuropsychiatric symptoms
Time frame: baseline, 6 weeks, and then every 6 months for 5 years
Caregiver strain
Time frame: baseline, 6 weeks, and then every 6 months for 5 years
Caregiver depression
Time frame: baseline, 6 weeks, and then every 6 months for 5 years
Caregiver preparedness
Time frame: baseline, 6 weeks, and then every 6 months for 5 years
Satisfaction Survey
Time frame: at 6 weeks
Stress hormone level
Time frame: at baseline and 6 weeks
Daily stress inventory
Time frame: at baseline and 6 weeks
Subjective stress
Time frame: at baseline and 6 weeks
Emotional affective state
Time frame: at baseline and 6 weeks
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 25 Jun 2021.
- Background: PubMed 17169938Gonyea JG, O'Connor MK, Boyle PA. Project CARE: a randomized controlled trial of a behavioral intervention group for Alzheimer's disease caregivers. Gerontologist. 2006 Dec;46(6):827-32. doi: 10.1093/geront/46.6.827.
- Please contact the UCF OLDeR Lab for any questions regarding the study and/or study materials.Link provided by the sponsor.
- 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.
Daniel L Paulson, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UCF Caregiver Support Group and Community Support Groups in people with Dementia and Alzheimer's Disease, run by University of Central Florida 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 1 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 25 Jun 2021. 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 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 in Long-Term Care Utilization based on Caregiver Report (time frame: baseline, 6 weeks, and then every 6 months for 5 years). 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 NCT02690896, 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 25 Jun 2021.