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Heart FailureCBTI-HFNCT02827799

Cognitive Behavioral Therapy for Insomnia in Stable Heart Failure

A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Heart Failure Self-Management Education in people with Heart Failure and Insomnia, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this exploratory developmental study is to test the feasibility, acceptability, and preliminary efficacy of cognitive behavioral therapy for insomnia (CBT-I) among adults who have stable Heart Failure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Insomnia, Cardiomyopathy
What is being tested?
Cognitive Behavioral Therapy for Insomnia (CBT-I) and Heart Failure Self-Management Education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
1 siteUnited States
Study dates
Aug 2009to Jul 2012
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stable chronic heart failure
  • reports of difficulty initiating or maintaining sleep or waking too early in the morning
  • English speaking/reading

Who cannot join

  • untreated sleep disordered breathing or restless legs syndrome
  • rotating/night shift work
  • active illicit drug use
  • bipolar disorder
  • neuromuscular conditions affecting the non-dominant arm
  • end-stage renal failure
  • significant cognitive impairment
  • unstable medical or psychiatric disorders

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Yale University School of Nursing

    West Haven, Connecticut, 06516-7399

Other trials in United States

About this study

The purpose of this exploratory developmental study is to test the feasibility, acceptability, and preliminary efficacy of cognitive behavioral therapy for insomnia (CBT-I) among adults who have stable Heart Failure. Participants were randomized either to a treatment (CBT-I) or attention-control condition (heart failure self management education).

Read the detailed description

Insomnia is common in adults with chronic heart failure (HF), a condition associated with functional performance deficits, symptom burden, and high levels of morbidity and mortality. To date there has been little study of strategies to improve sleep in this large population. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia comorbid with several medical and psychiatric disorders, but has not been tested in HF. The purpose of this exploratory developmental research is to test the feasibility, acceptability, and size of the effects of CBT-I on subjective and objective characteristics of sleep and insomnia symptoms and functional performance in patients with stable HF. Forty patients with stable HF will be randomized to 7 weeks of CBT-I or 7-weeks of HF self-management education with sleep hygiene (attention control). Subjective (diaries, questionnaires) and objective (wrist actigraphy) characteristics of sleep; symptoms, and self-reported functional performance will be measured pre- and post-intervention. The investigators will also obtain day and night measures of urinary free cortisol, free epinephrine/norepinephrine, and melatonin sulfate. They will: 1) refine the protocol, procedures, patient materials, and training manual for the CBT-I intervention and a group HF self-management class (attention-control); 2) evaluate the feasibility and acceptability of the CBT-I intervention and the attention-control conditions; 3) evaluate the size of the effects of group CBT-I, compared with attention-control, on objective (actigraph) and subjective (questionnaire and sleep diary) sleep characteristics, self-report of insomnia symptoms, and beliefs and attitudes about sleep; and 4) evaluate the size of the effects of CBT-I, compared with attention-control, on daytime symptoms (fatigue, depression, anxiety, excessive daytime sleepiness) and functional performance. The primary outcome will be self-reported sleep continuity (sleep efficiency). Investigators will also explore the effects of changes in characteristics of sleep and insomnia symptoms on symptoms and daytime function; the effects of CBT-I, compared with attention control, on nocturnal symptoms, and the effects of CBT-I, compared with attention control, on biological indicators of nocturnal and daytime Hypothalamic Adrenal Pituitary axis (urinary free cortisol), sympathetic nervous system (urinary epinephrine/norepinephrine, and pineal (urinary melatonin) function. The results will be used to support design decisions for a future larger scale efficacy study and may ultimately lead to translation of CBT-I into the care of patients with HF.

Being tested
Cognitive Behavioral Therapy for Insomnia (CBT-I), Heart Failure Self-Management Education
Keywords
heart failure, insomnia, sleep disorders, actigraphy, cardiomyopathy, depression, sleepiness, anxiety, fatigue
Medical subject headings
Heart Failure, Sleep Initiation and Maintenance Disorders, Cardiomyopathies, Sleep Wake Disorders, Depression, Sleepiness, Anxiety Disorders, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural

    This behavioral intervention includes training on managing the sleep environment (stimulus control), managing dysfunctional beliefs and attitudes about sleep (cognitive therapy), relaxation (progressive muscle relaxation), changing sleep behaviors (sleep hygiene), and managing sleep duration and continuity (sleep restriction).

  • Heart Failure Self-Management EducationBehavioural

    This intervention includes learning about how to manage one's heart failure. This includes understanding when to seek treatment, monitoring oneself for daily signs and symptoms, daily weight, dietary changes, physical activity, and adherence to medication taking.

Study groups in NCT02827799
Study groupRoleWhat they receive
Heart Failure Self-Management EducationPlacebo comparatorThis treatment includes participation in 4 one hour biweekly face-face sessions of education on heart failure self-management, as well as a 15 minute telephone call on intervening weeks. The total intervention is 8 weeks.
Receives: Behavioral: Heart Failure Self-Management Education
Cognitive Behavioral Therapy for Insomnia (CBT-I)ExperimentalThis treatment includes participation in 4 one hour biweekly face-face sessions of cognitive behavioral therapy for insomnia, as well as a 15 minute telephone call on intervening weeks. The total intervention is 8 weeks.
Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insomnia severity

    Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, subthreshold insomnia, moderate insomnia or severe insomnia.

    Measured: baseline two weeks after completing treatment or attention/control

Secondary outcomes (12)
  1. Depressive symptoms

    Depressive symptoms will be measured with the Center for Epidemiological Studies Depression Scale, a 20 item self-report instrument used to measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. These symptom groups include sadness, loss of Interest, appetite, sleep, thinking/concentration, guilt, fatigue, agitation, and suicidal ideation. Possible scores range from 0-60, and determination of depressive symptom category (no clinical significance, subthreshhold depression symptoms, possible major depressive episode, probable major depressive episode, and meets criteria for major depressive episode) is based upon an algorithm.

    Measured: Baseline and two weeks after completing treatment or attention control

  2. Sleepiness

    Sleepiness will be measured using the Epworth Sleepiness Scale (ESS) a report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.

    Measured: Baseline and two weeks after completing treatment or attention control

  3. Anxiety

    Anxiety will be measured with the Spielberger State Anxiety Inventory (STAI), a self-report instrument to measure the presence and severity of current symptoms of anxiety. The instrument includes 20 items to evaluate the current state of anxiety, using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. Scores range from 20-80, with higher scores indicating greater anxiety.

    Measured: Baseline and two weeks after completing treatment or attention-control

  4. Fatigue

    The symptom of fatigue will be measured with the Multidimensional Assessment of Fatigue Scale, a 16 item self-report instrument that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and its impact on various activities of daily living. The items are used to calculate scores for each of the four dimensions listed, as well as a global fatigue index (GFI). A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.

    Measured: baseline and two weeks after completing treatment or attention-control

  5. Sleep efficiency

    Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep efficiency will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.

    Measured: baseline and two weeks after completing treatment or attention control

  6. Functional Performance

    Functional performance will be measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health.

    Measured: baseline and two weeks after completing treatment or attention control

  7. Thoughts and beliefs about sleep

    This will be measured with a 16 item likert scale. The Dysfunctional Beliefs and Attitudes about Sleep Scale

    Measured: Baseline and two weeks after completing treatment or attention control.

  8. Cortisol

    We will measure urinary free cortisol as a biological measure of stress. Participants will provide urine specimens in the morning (from the previous night) and again late in the afternoon (reflecting the afternoon). This will enable understanding of both day and night levels of stress.

    Measured: baseline and two weeks after completing treatment or attention control.

  9. Melatonin

    We will measure melatonin as a biological measure of the circadian rhythm. Participants will provide urine specimens in the morning (from the previous night) and again late in the afternoon (reflecting the afternoon). This will enable understanding of both day and night levels of stress.

    Measured: baseline and two weeks after completing treatment or attention control.

  10. Epinephrine

    We will measure epinephrine ("adrenaline") as a biological measure of stress. Participants will provide urine specimens in the morning (from the previous night) and again late in the afternoon (reflecting the afternoon). This will enable understanding of both day and night levels of stress.

    Measured: baseline and two weeks after completing treatment or attention control.

  11. Norepinephrine

    We will measure norepinephrine as a biological measure of stress. Participants will provide urine specimens in the morning (from the previous night) and again late in the afternoon (reflecting the afternoon). This will enable understanding of both day and night levels of stress.

    Measured: baseline and two weeks after completing treatment or attention control.

  12. Nocturnal symptoms

    We will measure shortness of breath, nocturnia, and pain. Participants will complete a daily diary each morning upon awakening and indicate on a 10 item numeric scale the degree to which they experienced these symptoms during the past night.

    Measured: baseline and two weeks after completing treatment or attention control

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2016 (estimated)
  2. Study startAug 2009
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

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
Other
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02827799
Sponsor's protocol ID
0904005041_B
Other IDs
R21NR011387
Acronym
CBTI-HF
Status last verified
Apr 2020
First submitted
5 Jul 2016
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Redeker NS, Jeon S, Andrews L, Cline J, Jacoby D, Mohsenin V. Feasibility and Efficacy of a Self-Management Intervention for Insomnia in Stable Heart Failure. J Clin Sleep Med. 2015 Oct 15;11(10):1109-19. doi: 10.5664/jcsm.5082.

    PubMed 25979100
  • Breazeale S, Jeon S, Hwang Y, O'Connell M, Nwanaji-Enwerem U, Linsky S, Yaggi HK, Jacoby DL, Conley S, Redeker NS. Sleep Characteristics, Mood, Somatic Symptoms, and Self-Care Among People With Heart Failure and Insomnia. Nurs Res. 2022 May-Jun 01;71(3):189-199. doi: 10.1097/NNR.0000000000000585.

    PubMed 35149627
  • Redeker NS, Jeon S, Andrews L, Cline J, Mohsenin V, Jacoby D. Effects of Cognitive Behavioral Therapy for Insomnia on Sleep-Related Cognitions Among Patients With Stable Heart Failure. Behav Sleep Med. 2019 May-Jun;17(3):342-354. doi: 10.1080/15402002.2017.1357120. Epub 2017 Aug 22.

    PubMed 28745520

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Heart Failure Self-Management Education in people with Heart Failure and Insomnia, run by Yale University at 1 site 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?

The sponsor lists 3 inclusion and 8 exclusion criteria. 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 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

Insomnia severity (time frame: baseline two weeks after completing treatment or attention/control). 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 NCT02827799, which also lists 3 linked publications.

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 3 Apr 2020.

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CBTI-HF Clinical Trial NCT02827799 | AzTrials