Cognitive Behavioral Therapy for Insomnia in Stable Heart Failure (CBTI-HF)

Yale University

Status: Completed

Conditions: Cardiomyopathy; Insomnia; Heart Failure

Treatments: Behavioral: Heart Failure Self-Management Education; Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02827799

0904005041_B

R21NR011387 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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51 participants in 2 patient groups, including a placebo group

Heart Failure Self-Management Education

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Heart Failure Self-Management Education

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Experimental group

Description:

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.

Treatment:

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