I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia (Hit-IT)
July 30, 2020 updated by: Anders Broström, Jonkoping University
Internet-based Cognitive Behavioural Therapy Program Tailored to Patients With Cardiovascular Disease and Insomnia - Effects of a Randomised Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jönköping, Sweden, 553 18
- Jonkoping University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: I-CBT
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
|
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:
|
|
Active Comparator: Control group
3 weeks internet-based sleep hygiene education
|
Control group receiving 3 weeks internet-based education on sleep hygiene.
A module is given each week during the 3 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anders Broström, Professor, Jonkoping University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
February 1, 2020
Study Completion (Actual)
February 1, 2020
Study Registration Dates
First Submitted
May 2, 2019
First Submitted That Met QC Criteria
May 3, 2019
First Posted (Actual)
May 6, 2019
Study Record Updates
Last Update Posted (Actual)
July 31, 2020
Last Update Submitted That Met QC Criteria
July 30, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/258-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Sleep (Pittsburg Sleep Quality Index, Insomnia Severity Index, sleep diary), depressive- and cardiac symptoms (Patient Health Qurestionnaire-9, Cardiac Anxiety Questionnaire) and Quality of Life (SF-12) at baseline, during and after intervention (after 6 and 12 months).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.