This trial has been completed.

Conditions stress, depression
Treatments cognitive behavioral therapy (cbt), health education
Sponsor University of California, Los Angeles
Collaborator National Institute of Nursing Research (NINR)
Start date September 2013
End date May 2015
Trial size 50 participants
Trial identifier NCT01937936, 5K23NR013475


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Cognitive Behavioral Therapy (CBT)
cognitive behavioral therapy (cbt) Cognitive Therapy
Family caregivers in the CBT group will receive 8 1-hour weekly Cognitive Behavioral Therapy (CBT) sessions, which will take place in their home.
(Active Comparator)
Health Education
health education
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.

Primary Outcomes

Salivary cortisol
time frame: 8 weeks

Secondary Outcomes

Perceived stress
time frame: 8 weeks and 6 months
Depressive symptoms
time frame: 8 weeks and 6 months
Health-related quality of life
time frame: 8 weeks and 6 months
Health care usage
time frame: 6 months

Eligibility Criteria

Male or female participants at least 21 years old.

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)

Additional Information

Official title Stress and Health in Family Caregivers of Persons With Heart Failure
Principal investigator Boyoung Hwang, PhD, RN
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.