Clinical trial NCT02690896: Caregiver Burden and Depression: Caring for Those Who Care for Others
Official title: Caregiver Burden and Depression: Caring for Those Who Care for Others
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer's Disease
Keywords: caregiver burden
caregiver support groups
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: Alzheimer's and Dementia Resource Center
First posted: 2016-02-24
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Long-Term Care Utilization based on Caregiver Report
timeFrame: baseline, 6 weeks, and then every 6 months for 5 years
Secondary outcomes:
measure: Neuropsychiatric symptoms
timeFrame: baseline, 6 weeks, and then every 6 months for 5 years
measure: Caregiver strain
timeFrame: baseline, 6 weeks, and then every 6 months for 5 years
measure: Caregiver depression
timeFrame: baseline, 6 weeks, and then every 6 months for 5 years
measure: Caregiver preparedness
timeFrame: baseline, 6 weeks, and then every 6 months for 5 years
measure: Satisfaction Survey
timeFrame: at 6 weeks
measure: Stress hormone level
timeFrame: at baseline and 6 weeks
measure: Daily stress inventory
timeFrame: at baseline and 6 weeks
measure: Subjective stress
timeFrame: at baseline and 6 weeks
measure: Emotional affective state
timeFrame: at baseline and 6 weeks
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Daniel L Paulson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.