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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia

Clinicaltrials.gov identifier NCT03938805

Recruitment Status Completed

First Posted May 6, 2019

Last update posted July 31, 2020

Study Description

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.

  • Condition or Disease:Insomnia
    Cardiovascular Diseases
  • Intervention/Treatment: Behavioral: Internet-based cognitive behavioral therapy for insomnia
    Other: Control group
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 48 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: 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.
  • Masking: Single (Investigator)
  • Primary Purpose: Treatment
  • Official Title: Internet-based Cognitive Behavioural Therapy Program Tailored to Patients With Cardiovascular Disease and Insomnia - Effects of a Randomised Controlled Trial
  • Actual Study Start Date: March 2017
  • Actual Primary Completion Date: February 2020
  • Actual Study Completion Date: February 2020
Arms and interventions
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
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.
Active Comparator: Control group
3 weeks internet-based sleep hygiene education
Other: Control group
Control group receiving 3 weeks internet-based education on sleep hygiene. A module is given each week during the 3 weeks.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts
Locations

Sweden
Jönköping University
Jönköping

Sponsors and Collaborators

Jonkoping University

Investigators

Principal Investigator: Anders Broström, Professor Jonkoping University

More Information
  • Responsible Party: Jonkoping University
  • ClinicalTrials.gov Identifier: NCT03938805 History of Changes
  • Other Study ID Numbers: 2015/258-31
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: July 31, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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).
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders Cardiovascular Diseases