StressNCT01937936
Heart Failure Caregiver Study
A study testing Cognitive Behavioral Therapy (CBT) and Health Education in people with Stress and Depression, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stress, Depression
- What is being tested?
- Cognitive Behavioral Therapy (CBT) and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
2 sites in 1 country.
United States2 sites
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
UCLA Medical Center, Santa Monica
Santa Monica, California, 90404
About this study
Official title: Stress and Health in Family Caregivers of Persons With Heart Failure
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.
- Conditions
- Stress, Depression
- Being tested
- Cognitive Behavioral Therapy (CBT), Health Education
- Keywords
- caregiver stress, depression, quality of life, cognitive behavioral therapy
- Medical subject headings
- Depression, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
Also called Cognitive Therapy, Cognitive Behavioral Intervention, 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.
Health EducationBehavioural
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 group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Cognitive Behavioral Therapy (CBT) Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Education | Active comparator | Health Education Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol
Measured: 8 weeks
Secondary outcomes (4)
Perceived stress
Measured: 8 weeks and 6 months
Depressive symptoms
Measured: 8 weeks and 6 months
Health-related quality of life
Measured: 8 weeks and 6 months
Health care usage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Boyoung Hwang, PhD, RN, University of California, Los Angeles
- Investigators
- Boyoung Hwang, PhD, RN, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937936
- Sponsor's protocol ID
- 5K23NR013475
- Other IDs
- 5K23NR013475
- Status last verified
- Oct 2016
- First submitted
- 4 Sep 2013
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hwang B, Granger DA, Brecht ML, Doering LV. Cognitive behavioral therapy versus general health education for family caregivers of individuals with heart failure: a pilot randomized controlled trial. BMC Geriatr. 2022 Apr 5;22(1):281. doi: 10.1186/s12877-022-02996-7.
PubMed 35382758
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Health in Family Caregivers of Persons With Heart Failure
- ClinicalTrials.gov ID
- NCT01937936
- Acronym / sponsor ID
- 5K23NR013475
- Conditions
- Stress, Depression
- Keywords
- caregiver stress, depression, quality of life, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)Cognitive Behavioral Therapy (CBT) |
| Education | Active comparator | Behavioral: Health EducationHealth Education |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)Also: Cognitive Therapy, Cognitive Behavioral Intervention, CBTFamily caregivers in the CBT group will receive 8 1-hour weekly Cognitive Behavioral Therapy (CBT) sessions, which will take place in their home. | Behavioural | CBT |
| Health EducationFamily 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. | Behavioural | Education |
Primary outcome
Salivary cortisol
Time frame: 8 weeks
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Derived from this study: PubMed 35382758Hwang B, Granger DA, Brecht ML, Doering LV. Cognitive behavioral therapy versus general health education for family caregivers of individuals with heart failure: a pilot randomized controlled trial. BMC Geriatr. 2022 Apr 5;22(1):281. doi: 10.1186/s12877-022-02996-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boyoung Hwang, PhD, RN principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) and Health Education in people with Stress and Depression, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary cortisol (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01937936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.