Øystein Vedaa1,2,3, Susanne Hagatun3,4, Håvard Kallestad1,2, Ståle Pallesen5,6, Otto R F Smith3, Frances P Thorndike7, Lee M Ritterband8, Børge Sivertsen1,3,9. 1. Norwegian University of Science and Technology, Department of Mental Health, Faculty of Medicine and Health Sciences, Trondheim, Norway. 2. St. Olavs University Hospital, Division of Mental Health Care, Department of Østmarka, Trondheim, Norway. 3. Department of Health Promotion, Norwegian Institute of Public Health, Bergen, Norway. 4. Department of Clinical Psychology, University of Bergen, Bergen, Norway. 5. Department of Psychosocial Science, University of Bergen, Bergen, Norway. 6. Norwegian Competence Center for Sleep Disorders, Haukeland University Hospital, Bergen, Norway. 7. BeHealth Solutions, Charlottesville, Virginia. 8. Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia Health System, Charlottesville, Virginia. 9. Department of Research and Innovation, Helse Fonna HF, Haugesund, Norway.
Abstract
STUDY OBJECTIVES: The aim of this study was to test the efficacy of fully automated Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) 18 months after the intervention period on sleep, daytime functioning, and beliefs about sleep for adults with chronic insomnia. METHODS: Participants in this study had participated in a randomized controlled trial comparing the efficacy of unguided Internet CBT-I with web-based patient education. Participants who had received Internet CBT-I (n = 95) completedonline questionnaires and online sleep diaries 18 months after the intervention period. We used linear mixed models to study changes from baseline to postassessment and to 18-month follow-up, and a separate mixed-models analysis to study changes from postassessment to 18-month follow-up. RESULTS:Mean age of the participants was 45.5 years (standard deviation = 12.6) and 64% were females. Sixty-six participants (70%) completed the 18-month follow-up assessment. There were significant improvements from baseline to 18-month follow-up on the Insomnia Severity Index (ISI) (Cohen d = 2.04 [95% confidence interval (CI) 1.66-2.42]) and the Bergen Insomnia Scale (BIS) (d = 1.64 [95% CI 1.30-1.98]), levels of daytime fatigue (d = 0.85 [95% CI 0.59-1.11]), psychological distress (d = 0.51 [95% CI 0.29-0.73]), and beliefs about sleep (d = 1.44 [95% CI 1.15-1.73]). Moderate to large effect size improvements were also shown on the diary-derived sleep variables. All improvements from baseline to postassessment were essentially maintained to 18-month follow-up. CONCLUSIONS:Unguided Internet CBT-I appears to have sustained effects on sleep, daytime functioning, and beliefs about sleep up to 18 months after the intervention period. CLINICAL TRIAL REGISTRATION: This study presents long-term follow-up data of a previous clinical trial. Registry: ClinicalTrials.gov, Title: Internet-based Treatment for Insomnia in Norway, Identifier: NCT02261272, URL: https://clinicaltrials.gov/ct2/show/NCT02261272.
RCT Entities:
STUDY OBJECTIVES: The aim of this study was to test the efficacy of fully automated Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) 18 months after the intervention period on sleep, daytime functioning, and beliefs about sleep for adults with chronic insomnia. METHODS:Participants in this study had participated in a randomized controlled trial comparing the efficacy of unguided Internet CBT-I with web-based patient education. Participants who had received Internet CBT-I (n = 95) completed online questionnaires and online sleep diaries 18 months after the intervention period. We used linear mixed models to study changes from baseline to postassessment and to 18-month follow-up, and a separate mixed-models analysis to study changes from postassessment to 18-month follow-up. RESULTS: Mean age of the participants was 45.5 years (standard deviation = 12.6) and 64% were females. Sixty-six participants (70%) completed the 18-month follow-up assessment. There were significant improvements from baseline to 18-month follow-up on the Insomnia Severity Index (ISI) (Cohen d = 2.04 [95% confidence interval (CI) 1.66-2.42]) and the Bergen Insomnia Scale (BIS) (d = 1.64 [95% CI 1.30-1.98]), levels of daytime fatigue (d = 0.85 [95% CI 0.59-1.11]), psychological distress (d = 0.51 [95% CI 0.29-0.73]), and beliefs about sleep (d = 1.44 [95% CI 1.15-1.73]). Moderate to large effect size improvements were also shown on the diary-derived sleep variables. All improvements from baseline to postassessment were essentially maintained to 18-month follow-up. CONCLUSIONS: Unguided Internet CBT-I appears to have sustained effects on sleep, daytime functioning, and beliefs about sleep up to 18 months after the intervention period. CLINICAL TRIAL REGISTRATION: This study presents long-term follow-up data of a previous clinical trial. Registry: ClinicalTrials.gov, Title: Internet-based Treatment for Insomnia in Norway, Identifier: NCT02261272, URL: https://clinicaltrials.gov/ct2/show/NCT02261272.
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