Caregiver Burden and Depression: Caring for Those Who Care for Others
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|ClinicalTrials.gov Identifier: NCT02690896|
Recruitment Status : Recruiting
First Posted : February 24, 2016
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer's Disease||Behavioral: UCF Caregiver Support Group Behavioral: Community Support Groups||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Caregiver Burden and Depression: Caring for Those Who Care for Others|
|Actual Study Start Date :||February 24, 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||August 2020|
Experimental: UCF Behavioral Intervention Group
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.
Behavioral: UCF Caregiver Support Group
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.
Active Comparator: Community Comparison Group
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.
Behavioral: Community Support Groups
Comparison group members will come from local community support groups, which typically include components of social support and limited psychoeducation, and are relatively unstructured.
- 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.
- Neuropsychiatric symptoms [ Time Frame: baseline, 6 weeks, and then every 6 months for 5 years ]Caregivers will provide an assessment of their care recipient's neuropsychiatric functioning by completing the Neuropsychiatric Inventory.
- Caregiver strain [ Time Frame: baseline, 6 weeks, and then every 6 months for 5 years ]Caregivers will provide an assessment of the burden associated with caregiving that they experience by completing The Caregiver Strain Index.
- Caregiver depression [ Time Frame: baseline, 6 weeks, and then every 6 months for 5 years ]Caregiver depression will assessed by the Center for Epidemiologic Studies Short Depression Scale (CESD-10).
- Caregiver preparedness [ Time Frame: baseline, 6 weeks, and then every 6 months for 5 years ]Caregivers will complete the The Preparedness for Caregiving Scale to assess how prepared they feel to perform the various aspects of caregiving.
- Satisfaction Survey [ Time Frame: at 6 weeks ]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.
- Stress hormone level [ Time Frame: at baseline and 6 weeks ]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.
- Daily stress inventory [ Time Frame: at baseline and 6 weeks ]Daily stress will be measured using the Daily Inventory of Stressful Events to assess subjective psychological stress experienced.
- Subjective stress [ Time Frame: at baseline and 6 weeks ]The Pre-water Stress VAS will be used as another subjective measure of psychological stress experienced.
- Emotional affective state [ Time Frame: at baseline and 6 weeks ]The Positive and Negative Affect Schedule (PANAS) will be used as another subjective measure of psychological stress experienced.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690896
|Contact: Daniel L Paulson, PhD||407-823-3578||Daniel.Paulson2@ucf.edu|
|Contact: Mona K Shah, MAfirstname.lastname@example.org|
|United States, Florida|
|University of Central Florida||Recruiting|
|Orlando, Florida, United States, 32816|
|Contact: Daniel L Paulson, PhD 407-823-3578 Daniel.Paulson2@ucf.edu|
|Contact: Mona K Shah, MA 714-404-9199 email@example.com|
|Principal Investigator: Daniel L Paulson, PhD|
|Sub-Investigator: Mona Shah, MA|
|Sub-Investigator: Nichole Lighthall, PhD|
|Principal Investigator:||Daniel L Paulson, PhD||University of Central Florida|