Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-CBT | Experimental | 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 | Active Comparator | 3 weeks internet-based sleep hygiene education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anders Broström, Professor | Jonkoping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jönköping University | Jönköping | 553 18 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33609425 | Derived | 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. |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Randomized controlled trial. The intervention group participated in a nine-week internet-based cognitive behavioral therapy program. The initial parts of the program, focusing on cardiovascular disease was initially tailored to fit patients with heart failure and has undergone pilot testing. The intervention program used in the current study was adapted to fit also patient with other cardiovascular diagnoses (i.e., heart failure, myocardial infarction, atrial fibrillation) and comprise 1-week of introduction, 2 weeks psycho education on cardiovascular diseases/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction. The Control Group receive 3 weeks of internet-based sleep hygiene education.
Not provided
Not provided
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.
|
|
| Control group | Other | Control group receiving 3 weeks internet-based education on sleep hygiene. A module is given each week during the 3 weeks. |
|
| D001523 |
| Mental Disorders |
| D008722 | Methods |