Heart Failure Caregiver Study

Study Overview
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Brief Summary
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Family caregivers are vulnerable to health problems because of the stress and demands of their role as a caregiver. With the growing incidence of heart failure (HF) and the anticipated growth in the aging population, the number of HF caregivers is expected to rise. This study will pilot test a cognitive behavioral intervention designed to reduce stress among HF caregivers, which will ultimately contribute to promoting health and quality of life among HF caregivers and their loved ones with HF.

Official Title
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Stress and Health in Family Caregivers of Persons With Heart Failure

Conditions
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Stress, Depression

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy (CBT)
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria: 21 years or older Having primary or secondary diagnosis of HF (NYHA class II-IV) Having a family member or friend providing care for them at home Being able to communicate in English Patient Exclusion Criteria: Being on the transplant list Having terminal illness (e.g., terminal cancer) Caregiver Inclusion Criteria: 21 years or older Having the primary responsibility for the care of the patient for at least 6 months Living in the greater Los Angeles area Being able to communicate in English Caregiver Exclusion Criteria: Being a paid caregiver (an individual who is hired to provide care for the patient) Having terminal illness (e.g., terminal cancer) or a serious medical condition that requires ongoing medical care (e.g., cancer requiring ongoing chemotherapy or radiation therapy) Having a history of major psychiatric illness (i.e., schizophrenia, bipolar disorder, and/or any personality disorder) Diagnosed with Cushing's or Addison's disease Taking medication that could influence cortisol levels (e.g., steroid based anti-inflammatory drugs)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br>Cognitive Behavioral Therapy (CBT) | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* Family caregivers in the CBT group will receive 8 1-hour weekly Cognitive Behavioral Therapy (CBT) sessions, which will take place in their home.<br>* Other names: CBT;|
| Active Comparator: Education<br>Health Education | Behavioral: Health Education<br>* Family caregivers in the Education group will receive 8 1-hour weekly sessions of general health education on selected topics, which will take place in their home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary cortisol |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived stress |  | 8 weeks and 6 months | 
| Depressive symptoms |  | 8 weeks and 6 months | 
| Health-related quality of life |  | 8 weeks and 6 months | 
| Health care usage |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caregiver stress, depression, quality of life, cognitive behavioral therapy