Clinical trial NCT03938805: I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia
Official title: Internet-based Cognitive Behavioural Therapy Program Tailored to Patients With Cardiovascular Disease and Insomnia - Effects of a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Cardiovascular Diseases
Lead sponsor: Jonkoping University
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial. The intervention group participated in a nine-week internet-based cognitive behavioral therapy program. The initial parts of the program, focusing on cardiovascular disease was initially tailored to fit patients with heart failure and has undergone pilot testing. The intervention program used in the current study was adapted to fit also patient with other cardiovascular diagnoses (i.e., heart failure, myocardial infarction, atrial fibrillation) and comprise 1-week of introduction, 2 weeks psycho education on cardiovascular diseases/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction. The Control Group receive 3 weeks of internet-based sleep hygiene education.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia severity index (ISI)
timeFrame: 12 months
Secondary outcomes:
measure: Short Form 12 (SF-12)
timeFrame: 12 months
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Jönköping University
Study officials:
affiliation: Jonkoping University
name: Anders Broström, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siebmanns S, Johansson P, Ulander M, Johansson L, Andersson G, Brostrom A. The effect of nurse-led Internet-based cognitive behavioural therapy for insomnia on patients with cardiovascular disease: A randomized controlled trial with 6-month follow-up. Nurs Open. 2021 Jul;8(4):1755-1768. doi: 10.1002/nop2.817. Epub 2021 Feb 20.