Cognitive Behavioral Therapy for Insomnia in Stable Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-07-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Heart Failure Insomnia Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Heart Failure Self-Management Education

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.

Group Type PLACEBO_COMPARATOR

Heart Failure Self-Management Education

Intervention Type BEHAVIORAL

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.

Cognitive Behavioral Therapy for Insomnia (CBT-I)

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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Intervention Type 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).

Interventions

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Cognitive Behavioral Therapy for Insomnia (CBT-I)

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).

Intervention Type BEHAVIORAL

Heart Failure Self-Management Education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No