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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 : October 15, 2018
Sponsor:
Collaborator:
Alzheimer's and Dementia Resource Center
Information provided by (Responsible Party):
Daniel Paulson, University of Central Florida

Brief 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.

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Caregiver Burden and Depression: Caring for Those Who Care for Others
Actual Study Start Date : February 24, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

- Participants who do not speak English


Information from the National Library of Medicine

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


Contacts
Contact: Daniel L Paulson, PhD 407-823-3578 Daniel.Paulson2@ucf.edu
Contact: Mona K Shah, MA 714-404-9199 mshah@knights.ucf.edu

Locations
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    mshah@knights.ucf.edu   
Principal Investigator: Daniel L Paulson, PhD         
Sub-Investigator: Mona Shah, MA         
Sub-Investigator: Nichole Lighthall, PhD         
Sponsors and Collaborators
University of Central Florida
Alzheimer's and Dementia Resource Center
Investigators
Principal Investigator: Daniel L Paulson, PhD University of Central Florida

Additional Information:
Study Data/Documents: Study-related materials  This link exits the ClinicalTrials.gov site
Please contact the UCF OLDeR Lab for any questions regarding the study and/or study materials.

Publications:
Responsible Party: Daniel Paulson, Assistant Professor, University of Central Florida
ClinicalTrials.gov Identifier: NCT02690896     History of Changes
Other Study ID Numbers: SBE-15-11548
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daniel Paulson, University of Central Florida:
caregiver burden
caregiver support groups

Additional relevant MeSH terms:
Depression
Alzheimer Disease
Dementia
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders