NCT02827799

Brief 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. Participants were randomized either to a treatment (CBT-I) or attention-control condition (heart failure self management education).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

July 5, 2016

Last Update Submit

April 1, 2020

Conditions

Heart FailureInsomniaCardiomyopathy

Keywords

heart failureinsomniasleep disordersactigraphycardiomyopathydepressionsleepinessanxietyfatigue

Outcome Measures

Primary Outcomes (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.

    baseline two weeks after completing treatment or attention/control

Secondary Outcomes (12)

  • Depressive symptoms

    Baseline and two weeks after completing treatment or attention control

  • Sleepiness

    Baseline and two weeks after completing treatment or attention control

  • Anxiety

    Baseline and two weeks after completing treatment or attention-control

  • Fatigue

    baseline and two weeks after completing treatment or attention-control

  • Sleep efficiency

    baseline and two weeks after completing treatment or attention control

  • +7 more secondary outcomes

Study Arms (2)

Heart Failure Self-Management Education

PLACEBO COMPARATOR

This 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.

Behavioral: Heart Failure Self-Management Education

Cognitive Behavioral Therapy for Insomnia (CBT-I)

EXPERIMENTAL

This 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.

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I)BEHAVIORAL

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).

Cognitive Behavioral Therapy for Insomnia (CBT-I)
Heart Failure Self-Management EducationBEHAVIORAL

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.

Heart Failure Self-Management Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Nursing

West Haven, Connecticut, 06516-7399, United States

Location

Related Publications (3)

  • 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.

    PMID: 25979100RESULT

  • 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.

    PMID: 35149627DERIVED

  • 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.

    PMID: 28745520DERIVED

MeSH Terms

Conditions

Heart FailureSleep Initiation and Maintenance DisordersCardiomyopathiesSleep Wake DisordersDepressionSleepinessAnxiety DisordersFatigue

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Nancy S. Redeker, PhD, RN

    Yale University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 11, 2016

Study Start

August 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)