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Heart Failure Caregiver Study

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status

Completed

Conditions

Depression
Stress

Treatments

Behavioral: Health Education
Behavioral: Cognitive Behavioral Therapy (CBT)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01937936
5K23NR013475 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

CBT
Experimental group
Description:
Cognitive Behavioral Therapy (CBT)
Treatment:
Behavioral: Cognitive Behavioral Therapy (CBT)
Education
Active Comparator group
Description:
Health Education
Treatment:
Behavioral: Health Education

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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