Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease

NCT06749951 | Recruiting

• 1 other identifier: 678911
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Insomnia is prevalent (45%) in CHD patients and associated with significantly increased risk for recurrent cardiovascular events. Insomnia has recently been identified as the third most important risk factor for prognosis. However, very few insomnia patients are identified and receive treatment of insomnia today. CBT-I is the first-line treatment for insomnia, but studies on the effects in CHD patients are lacking. This project aims to document the effectiveness of Cognitive Behavioural therapy for insomnia (CBT-I) in an outpatient population with coronary heart disease (CHD). Furthermore, the biological and psychological mechanisms that may mediate the effects of the intervention will be identified. Finally, a health-economic simulation and a qualitative study of the participants experiences with CBT-I will be performed. This prospective, randomized, intervention study will continue until data have been collected for the primary outcome on 66 CHD outpatients with a diagnosis of insomnia assessed by Bergen Insomnia Scale (BIS). Participants will be randomised to a short, nurse-administered, CBT-I delivered in a group format or to sleep hygiene advice. The primary outcome will be remission from BIS-insomnia post-treatment and at 6-months follow-up. Secondary outcomes will be changes in insomnia severity, objective and subjective sleep parameters, daytime symptoms of insomnia, and quality of life. Exploratory outcomes include inflammation, cortisol, HbA1C, and cognitions/metacognitions. The project may document the effectiveness of CBT-I for a large patient-group with potentially favorable long-term effects on important clinical outcomes.

Conditions

Insomnia Chronic; Coronary Heart Disease

Outcome Measures

Primary Outcomes (2)

• Remission clinical diagnosis of insomnia

  Between- and within- group differences in the proportion witn remission of insomnia diagnosis assessed by the Bergen Insomnia Scale

  From baseline to weeks 6-8 and 26

• Changes in insomnia severity

  Between- and within- group differences in insomnia severity assessed by the Insomnia Severity Index

  From baseline to weeks 6-8 and 26

Secondary Outcomes (14)

• Changes in insomnia assessed by the Pittsburgh Sleep Quality Index

  From baseline to weeks 6-8 and 26

• Changes in subjective sleep efficiency

  From baseline to weeks 6-8 and 26

• Changes in objective sleep efficiency

  From baseline to weeks 6-8 and 26

• Changes in subjective total sleep time

  From baseline to weeks 6-8 and 26

• Changes in objective total sleep time

  From baseline to weeks 6-8 and 26

Study Arms (2)

Cognitive Behavioural Therapy for insomnia (CBT-I)

EXPERIMENTAL

Other: Cognitive Behavioural Therapy for insomnia (CBT-I)

Sleep Hygiene Advice

ACTIVE COMPARATOR

Other: Sleep Hygiene Advice

Interventions

Cognitive Behavioural Therapy for insomnia (CBT-I) OTHER

Five 60-90 minutes weekly sessions delivered by an appropriately trained cardiac nurse at a cardiology department. The CBT-I intervention will follow a manualized treatment protocol developed by Espie and colleagues (Espie et al. 2001, 2007, 2008) and evaluated in a number of published RCTs using CBT-I. The key components of this intervention include sleep hygiene advice, stimulus control, sleep restriction, relaxation training, and cognitive restructuring.

Cognitive Behavioural Therapy for insomnia (CBT-I)

Sleep Hygiene Advice OTHER

"Sleep well" is a 16-page written brochure developed by the Directorate of Health in Norway for dissemination to patients with sleep problems including insomnia. It covers general sleep hygiene advice (setting a regular bed-time, avoiding stimulants, alcohol and exercise in the evening, sleeping in a quiet bedroom, advice of practicing relaxation technique and postpone worries).

Sleep Hygiene Advice

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years and signed informed consent and expected cooperation according to ICH/GCP and national/local regulations
• Hospitalised with acute myocardial infarction and/or angiography-verified coronary atherosclerosis, or a coronary revascularisation procedure at Drammen Hospital 2021-2024
• A positive score for insomnia measured with Bergen Insomnia Score
• At least 10 of 14 daily diaries completed of the sleep diary during pre-randomization assessment

You may not qualify if:

• Any condition or situation, that in the investigator's opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible not limited to:
• Moderate or severe cognitive impairment (i.e. recorded in hospital records or a Montreal Cognitive Assessment brief version score \< 11), seizure disorders, active suicidal intent or plans, substance or alcohol dependence, psychotic disease, major depressive disorders or bipolar disorders, receiving concurrent psychological treatments, and ongoing night shift work.
• Neurological or musculoskeletal disorders that restrict movement of the dominant arm because of the possible confounding effects on wrist actigraphy recordings.
• A diagnosis of heart failure recorded in the hospital medical records and/or an NT-proBNP \>125 pg/mL
• Short life expectancy (\<12 months) due to end-organ (i.e COPD 4, CKD 4/5) or malignant diseases
• Not being able to understand Norwegian.
• No other significant sleep disorder, as assessed via the Structured Clinical Interview for Sleep disorders (Kallestad et al., 2022)
• A clinical diagnosis of Obstructive Sleep Apnea (OSA) (not treated with CPAP) recorded in the hospital medical records, under evaluation for OSA, and/or a score ≥5 on the STOP-Bang OSA screening questionnaire

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• Oslo University Hospital: collaborator
• University of Oslo: collaborator

Study Sites (1)

Vestre Viken Trust Drammen hospital

Drammen, Buskerud, 3014, Norway

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Coronary Disease

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

John D Munkhaugen, MD, PhD

CONTACT

+4797524194; johmun@vestreviken.no

Toril Dammen, MD, PhD

CONTACT

+4790163433; toril.dammen@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 27, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

NO (1)