I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia
Hit-IT
Internet-based Cognitive Behavioural Therapy Program Tailored to Patients With Cardiovascular Disease and Insomnia - Effects of a Randomised Controlled Trial
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 2, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedJuly 31, 2020
July 1, 2020
2.9 years
May 2, 2019
July 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Short Form 12 (SF-12)
12 months
Study Arms (2)
I-CBT
EXPERIMENTALInternet-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
ACTIVE COMPARATOR3 weeks internet-based sleep hygiene education
Interventions
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.
Control group receiving 3 weeks internet-based education on sleep hygiene. A module is given each week during the 3 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jönköping University
Jönköping, 553 18, Sweden
Related Publications (1)
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.
PMID: 33609425DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Broström, Professor
Jonkoping University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Single blinded (PI). The randomization is performed by a study team member who was blinded to screening and baseline data. The physician who assessed the patients had access to them in a random sequence. Patients were randomized 1.1 to nine-week internet-based cognitive behavioral therapy (intervention group) or online 3 weeks sleep hygiene (control group) generated by an independent researcher using a block size of two. Masking of patients was not possible since the interventions is a internet-based cognitive behavioral therapy program. Outcome measures were not necessary to mask since these were automatically collected via the study platform.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 2, 2019
First Posted
May 6, 2019
Study Start
March 1, 2017
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
July 31, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share
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).