I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Insomnia
• Interventions: Behavioral: Internet-based cognitive behavioral therapy for insomnia; Other: Control group

• Registration Number: NCT03938805
• Lead Sponsor: Jonkoping University

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).

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-CBT	Internet-based cognitive behavioral therapy for insomnia	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
Control group	Control group	3 weeks internet-based sleep hygiene education

Primary Outcome Measures

Name	Time	Method
Insomnia severity index (ISI)	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 Outcome Measures

Name	Time	Method
Short Form 12 (SF-12)	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.

Trial Locations

Locations (1)

Jönköping University; 🇸🇪 Jönköping, Sweden