I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia (Hit-IT)

Jonkoping University

Status: Completed

Conditions: Insomnia; Cardiovascular Diseases

Treatments: Behavioral: Internet-based cognitive behavioral therapy for insomnia; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03938805

2015/258-31

Details and patient eligibility

About

The Hit-IT study is based on an internet-based cognitive behavioral therapy program tailored to patients with different types of cardiovascular diseases and insomnia. A randomized controlled trial design is used. A 9 weeks internet-based cognitive behavioral therapy intervention vs a 3 weeks sleep hygiene education.

Full description

DESIGN: Randomized controlled trial with 1-year follow-up. All patients with cardiovascular disease (i.e., myocardial infarction, heart failure, atrial fibrillation and angina) from 4 primary care centers will be screened for insomnia and during a clinical examination diagnosed by a physician specialized in sleep medicine. INTERVENTION: 9 weeks internet-based cognitive behavioral therapy for insomnia (1 week introduction, 2 weeks psycho education on cardiovascular disease/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction) vs 3 weeks internet-based sleep hygiene education. QUESTIONNAIRES: Sleep (Pittsburgh Sleep Quality Index, Insomnia Severity Index, sleep diary), depressive- and cardiac symptoms (Patient Health Questionnaire-9, Cardiac Anxiety Questionnaire) and Quality of Life (SF-12) at baseline, during and after intervention (after 6 and 12 months).

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 18 years
• having a clinical diagnose of insomnia
• being treated for heart failure, coronary artery disease or atrial fibrillation
• access to a computer with an Internet connection, access to a mobile phone and was willing to participate in a treatment for their insomnia.

Exclusion criteria

• no access to internet, computer or cellphone.
• not understanding the Swedish language
• suffering from cognitive disabilities, severe psychiatric disease, severe somatic disease or sleep apnea
• suffering from drug abuse
• been hospitalised for heart failure, coronary artery disease or atrial fibrillation in the last four weeks
• expected survival less than 12 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

I-CBT

Experimental group

Description:

Internet-based cognitive behavioral therapy program including 1-week introduction, 2 weeks psycho education on Cardiovascular disease/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction

Treatment:

Behavioral: Internet-based cognitive behavioral therapy for insomnia

Control group

Active Comparator group

Description:

3 weeks internet-based sleep hygiene education

Treatment:

Other: Control group