Heart Failure Caregiver Study

Stress and Health in Family Caregivers of Persons With Heart Failure

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01937936

Enrollment

Registered

2013-09-10

Start date

2013-09-30

Completion date

2015-05-31

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Stress

Keywords

caregiver stress, depression, quality of life, cognitive behavioral therapy

Brief summary

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy (CBT)

Family caregivers in the CBT group will receive 8 1-hour weekly Cognitive Behavioral Therapy (CBT) sessions, which will take place in their home.

BEHAVIORALHealth 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Salivary cortisol	8 weeks

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026