Skip to main content
OpenTrials
Completed

NCT Number: NCT03938805

I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insomnia Cardiovascular Diseases Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jönköping University

Jönköping, 553 18, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based cognitive behavioral therapy for insomnia

Behavioral

Patients will be provided with psycho education on different cardiovascular diseases, sleep, insomnia, and provided with different behavioral techniques to improve their sleep. The participants in the intervention Group who receives the Internet-based cognitive behavioral therapy program will also have access to support given by a nurse specialized in sleep. A module is given each week during the 9-week intervention.

Other names: Internet-based CBT

Control Group

Other

Control group receiving 3 weeks internet-based education on sleep hygiene. A module is given each week during the 3 weeks.

Primary outcomes

  1. Insomnia severity index (ISI)

    Time frame: 12 months

    The Insomnia severity index is a self-assessment questionnaire that measure the perceived severity of insomnia symptoms such as, falling asleep, staying asleep, numbers of awakenings, early awakening, sleep satisfaction. The scale includes of seven items, scored on a 0- 4 scale that are summed to a range of 0 - 28. The score can be divided into four categories: no clinical insomnia (0-7), subthreshold insomnia (8-14), clinical insomnia of moderate severity (15-21), and severe clinical insomnia (22-28). The total score and the categories will be used.

Secondary outcomes

  1. Short Form 12 (SF-12)

    Time frame: 12 months

    The Short Form 12 Health Survey is a self-assessment questionnaire that measures the respondents quality of life through 12 questions. The 12 items are rated on a 5-point Likert scale, and 2 component scale scores (i.e., the physical component scale and the mental component scale) will be computed.

Sponsors and collaborators

Lead sponsor

Jonkoping University

Other

Registry information

Official study title

Internet-based Cognitive Behavioural Therapy Program Tailored to Patients With Cardiovascular Disease and Insomnia - Effects of a Randomised Controlled Trial

Acronym: Hit-IT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 6, 2019
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.