I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia

Cardiovascular Diseases Clinical Trial

— Hit-IT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03938805
• Other study ID #: 2015/258-31
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: February 1, 2020

Study information

• Verified date: July 2020
• Source: Jonkoping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Internet-based cognitive behavioral therapy for insomnia
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:
• Control group
Control group receiving 3 weeks internet-based education on sleep hygiene. A module is given each week during the 3 weeks.

Locations

Country	Name	City	State
Sweden	Jönköping University	Jönköping

Sponsors (1)

Lead Sponsor	Collaborator
Jonkoping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia severity index (ISI)	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.	12 months
Secondary	Short Form 12 (SF-12)	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.	12 months