Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep

被引:17
作者
Kallestad, Havard [1 ,2 ]
Vedaa, Oystein [1 ,2 ,3 ]
Scott, Jan [2 ,4 ]
Morken, Gunnar [2 ,5 ]
Pallesen, Stale [6 ]
Harvey, Allison G. [7 ]
Gehrman, Phil [8 ]
Thorndike, Frances [9 ]
Ritterband, Lee [10 ]
Stiles, Tore Charles [11 ]
Sivertsen, Borge [2 ,3 ,12 ]
机构
[1] St Olavs Univ Hosp, Dept Res & Dev, Trondheim, Norway
[2] Norwegian Univ Sci & Technol, Dept Mental Hlth, Trondheim, Norway
[3] Norwegian Inst Publ Hlth, Dept Hlth Promot, Bergen, Norway
[4] Newcastle Univ, Inst Neurosci, Newcastle Upon Tyne, Tyne & Wear, England
[5] St Olavs Univ Hosp, Dept Mental Hlth Care, Trondheim, Norway
[6] Univ Bergen, Fac Psychol, Dept Psychosocial Sci, Bergen, Norway
[7] Univ Calif Berkeley, Dept Psychol, 3210 Tolman Hall, Berkeley, CA 94720 USA
[8] Univ Penn, Dept Psychiat, Philadelphia, PA 19104 USA
[9] BeHlth Solut LLC, Charlottesville, VA USA
[10] Univ Virginia, Dept Psychiat & Neurobehav Sci, Charlottesville, VA USA
[11] Norwegian Univ Sci & Technol, Dept Psychol, Trondheim, Norway
[12] Helse Fonna, Dept Res & Innovat, Haugesund, Norway
关键词
sleep medicine; psychiatry; adult psychiatry; clinical trials; public health; ADULT NORWEGIAN POPULATION; DEPRESSION SCALE; HOSPITAL ANXIETY; SEVERITY INDEX; CLINICAL-TRIAL; HEALTH SURVEY; PREVALENCE; DISABILITY; SYMPTOMS; COHORT;
D O I
10.1136/bmjopen-2018-025152
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Introduction Insomnia is a major public health concern. While cognitive behaviour therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socioeconomic benefits and its impact on health resource utilisation. The aim of this randomised controlled trial (RCT) is to investigate the effectiveness of a fully automated online version of CBT-I compared with online patient education about sleep (PE). Outcome measures comprise changes in symptoms of insomnia, time off work due to sick leave as well as medication and health resource utilisation. Also, we will examine (i) putative mediators of the effects of CBT-I on insomnia severity and (ii) selected potential psycho-bio-social moderators of the effects of the interventions. Methods and analysis A parallel-group RCT will be conducted in a target sample of about 1500 adults recruited across Norway. Participants will complete an online screening and consent process. Those who meet eligibility criteria will be randomised to receive direct access to fully automated online CBT-I or to an online PE programme. The primary outcome is change in insomnia severity immediately postintervention; secondary outcomes are change in daytime functioning and other sleep measures postintervention and at 6-month and 24-month follow-up. Objective data from national registries will be obtained at two time points (1 year and 2years post-treatment), allowing a mirror image study of preintervention and postintervention rates of sick leave, and of medication and healthcare utilisation by condition. Ethics and dissemination The study protocol was approved by the Regional Committee for Medical and Health Research Ethics in South East Norway (2015/134). Findings from the RCT will be disseminated in peer-reviewed publications and conference presentations. Exploratory analyses of potential mediators and moderators will be reported separately. User-friendly outputs will be disseminated to patient advocacy and other relevant organisations. Trial registration number NCT02558647; Pre-results.
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页数:11
相关论文
共 57 条
[1]   HORNE AND OSTBERG MORNINGNESS EVENINGNESS QUESTIONNAIRE - A REDUCED SCALE [J].
ADAN, A ;
ALMIRALL, H .
PERSONALITY AND INDIVIDUAL DIFFERENCES, 1991, 12 (03) :241-253
[2]   Circadian Typology: A Comprehensive Review [J].
Adan, Ana ;
Archer, Simon N. ;
Paz Hidalgo, Maria ;
Di Milia, Lee ;
Natale, Vincenzo ;
Randler, Christoph .
CHRONOBIOLOGY INTERNATIONAL, 2012, 29 (09) :1153-1175
[3]  
[Anonymous], 2000, DIAGN STAT MAN MENT, DOI DOI 10.1176/APPI.BOOKS.9780890425787
[4]   THE MODERATOR MEDIATOR VARIABLE DISTINCTION IN SOCIAL PSYCHOLOGICAL-RESEARCH - CONCEPTUAL, STRATEGIC, AND STATISTICAL CONSIDERATIONS [J].
BARON, RM ;
KENNY, DA .
JOURNAL OF PERSONALITY AND SOCIAL PSYCHOLOGY, 1986, 51 (06) :1173-1182
[5]   Trajectories of change and long-term outcomes in a randomised controlled trial of internet-based insomnia treatment to prevent depression [J].
Batterham, Philip J. ;
Christensen, Helen ;
Mackinnon, Andrew J. ;
Gosling, John A. ;
Thorndike, Frances P. ;
Ritterband, Lee M. ;
Glozier, Nick ;
Griffiths, Kathleen M. .
BJPSYCH OPEN, 2017, 3 (05) :228-235
[6]   SYNTHESIZING STANDARDIZED MEAN-CHANGE MEASURES [J].
BECKER, BJ .
BRITISH JOURNAL OF MATHEMATICAL & STATISTICAL PSYCHOLOGY, 1988, 41 :257-278
[7]   Therapygenetics: moving towards personalized psychotherapy treatment [J].
Beevers, Christopher G. ;
McGeary, John E. .
TRENDS IN COGNITIVE SCIENCES, 2012, 16 (01) :11-12
[8]   The AUDIT alcohol consumption questions (AUDIT-C) - An effective brief screening test for problem drinking [J].
Bush, K ;
Kivlahan, DR ;
McDonell, MB ;
Fihn, SD ;
Bradley, KA .
ARCHIVES OF INTERNAL MEDICINE, 1998, 158 (16) :1789-1795
[9]   Impact of experimental design on effect size: Findings from the research literature on training [J].
Carlson, KD ;
Schmidt, FL .
JOURNAL OF APPLIED PSYCHOLOGY, 1999, 84 (06) :851-862
[10]   The Consensus Sleep Diary: Standardizing Prospective Sleep Self-Monitoring [J].
Carney, Colleen E. ;
Buysse, Daniel J. ;
Ancoli-Israel, Sonia ;
Edinger, Jack D. ;
Krystal, Andrew D. ;
Lichstein, Kenneth L. ;
Morin, Charles M. .
SLEEP, 2012, 35 (02) :287-302