Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy
Abstract Study Objectives Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical...
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Veröffentlicht in: | Sleep (New York, N.Y.) N.Y.), 2021-12, Vol.44 (12), p.1 |
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creator | Kallestad, Håvard Scott, Jan Vedaa, Øystein Lydersen, Stian Vethe, Daniel Morken, Gunnar Stiles, Tore Charles Sivertsen, Børge Langsrud, Knut |
description | Abstract
Study Objectives
Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity.
Methods
Eligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33.
Results
Individuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was −2.8 (95% CI: −4.8 to −0.8; p = 0.007, Cohen’s d = 0.7), and −4.6 at week 9 (95% CI −6.6 to −2.7; p < 0.001), Cohen’s d = 1.2.
Conclusions
At the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I.
Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial. |
doi_str_mv | 10.1093/sleep/zsab185 |
format | Article |
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Study Objectives
Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity.
Methods
Eligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33.
Results
Individuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was −2.8 (95% CI: −4.8 to −0.8; p = 0.007, Cohen’s d = 0.7), and −4.6 at week 9 (95% CI −6.6 to −2.7; p < 0.001), Cohen’s d = 1.2.
Conclusions
At the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I.
Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial.</description><identifier>ISSN: 0161-8105</identifier><identifier>EISSN: 1550-9109</identifier><identifier>DOI: 10.1093/sleep/zsab185</identifier><identifier>PMID: 34291808</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Adult ; Behavior modification ; Behavioral health care ; Care and treatment ; Clinical trials ; Cognitive Behavioral Therapy ; Cognitive therapy ; Humans ; Insomnia ; Insomnia and Psychiatric Disorders ; Internet ; Medical research ; Medicine, Experimental ; Mental health ; Psychiatric services ; Sleep ; Sleep Initiation and Maintenance Disorders - therapy ; Treatment Outcome</subject><ispartof>Sleep (New York, N.Y.), 2021-12, Vol.44 (12), p.1</ispartof><rights>The Author(s) 2021. Published by Oxford University Press on behalf of Sleep Research Society. 2021</rights><rights>Sleep Research Society 2021. Published by Oxford University Press on behalf of the Sleep Research Society.</rights><rights>COPYRIGHT 2021 Oxford University Press</rights><rights>Sleep Research Society 2021. Published by Oxford University Press on behalf of the Sleep Research Society. 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c515t-9edb4c39ee57bf7d2df0c228e96ae7bc76a7ec437c6407faf28a40ee3c5707223</citedby><cites>FETCH-LOGICAL-c515t-9edb4c39ee57bf7d2df0c228e96ae7bc76a7ec437c6407faf28a40ee3c5707223</cites><orcidid>0000-0002-9173-942X ; 0000-0002-7203-8601 ; 0000-0003-1972-5901 ; 0000-0003-4654-9296 ; 0000-0001-5028-3457</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34291808$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kallestad, Håvard</creatorcontrib><creatorcontrib>Scott, Jan</creatorcontrib><creatorcontrib>Vedaa, Øystein</creatorcontrib><creatorcontrib>Lydersen, Stian</creatorcontrib><creatorcontrib>Vethe, Daniel</creatorcontrib><creatorcontrib>Morken, Gunnar</creatorcontrib><creatorcontrib>Stiles, Tore Charles</creatorcontrib><creatorcontrib>Sivertsen, Børge</creatorcontrib><creatorcontrib>Langsrud, Knut</creatorcontrib><title>Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy</title><title>Sleep (New York, N.Y.)</title><addtitle>Sleep</addtitle><description>Abstract
Study Objectives
Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity.
Methods
Eligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33.
Results
Individuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was −2.8 (95% CI: −4.8 to −0.8; p = 0.007, Cohen’s d = 0.7), and −4.6 at week 9 (95% CI −6.6 to −2.7; p < 0.001), Cohen’s d = 1.2.
Conclusions
At the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I.
Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial.</description><subject>Adult</subject><subject>Behavior modification</subject><subject>Behavioral health care</subject><subject>Care and treatment</subject><subject>Clinical trials</subject><subject>Cognitive Behavioral Therapy</subject><subject>Cognitive therapy</subject><subject>Humans</subject><subject>Insomnia</subject><subject>Insomnia and Psychiatric Disorders</subject><subject>Internet</subject><subject>Medical research</subject><subject>Medicine, Experimental</subject><subject>Mental health</subject><subject>Psychiatric services</subject><subject>Sleep</subject><subject>Sleep Initiation and Maintenance Disorders - therapy</subject><subject>Treatment Outcome</subject><issn>0161-8105</issn><issn>1550-9109</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFUktv1DAQjhCILoUjV2SJC5e0fsYJB6Sy4lGpiEs5W44z3nWV2MFOVtr-Cn4yDru0FCEhH2bG8803z6J4SfAZwQ07Tz3AeH6bdEtq8ahYESFw2WTX42KFSUXKmmBxUjxL6QZnmzfsaXHCOG1IjetV8eNL6AAFizro3Q7iftHXYePdlE30HrZ650LUPbreQtTjHtkQ0aVPYfBOv0UaRe27MLhb6JAJfoqh77Pqgy-dtxBzsJv2aIoucyx53MZNWc1RyGoD5RTKRaLpwP-8eGJ1n-DFUZ4W3z5-uF5_Lq--frpcX1yVRhAxlQ10LTesARCytbKjncWG0hqaSoNsjay0BMOZNBXH0mpLa80xADNCYkkpOy3eHXjHuR2gM5BL170aoxt03KugnXro8W6rNmGn6qriomkywZsjQQzfZ0iTGlwy0PfaQ5iTokJwJigjC_T1X9CbMEef21O0ynvIZQp8j9roHlQeXsh5zUKqLiTGVHDCeEad_QOVXweDywsA6_L_g4DyEGBiSCmCveuRYLWckPp1Qup4Qhn_6s_B3KF_38x942Ee_8P1E2cI1Cc</recordid><startdate>20211201</startdate><enddate>20211201</enddate><creator>Kallestad, Håvard</creator><creator>Scott, Jan</creator><creator>Vedaa, Øystein</creator><creator>Lydersen, Stian</creator><creator>Vethe, Daniel</creator><creator>Morken, Gunnar</creator><creator>Stiles, Tore Charles</creator><creator>Sivertsen, Børge</creator><creator>Langsrud, Knut</creator><general>Oxford University Press</general><scope>TOX</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>MBDVC</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-9173-942X</orcidid><orcidid>https://orcid.org/0000-0002-7203-8601</orcidid><orcidid>https://orcid.org/0000-0003-1972-5901</orcidid><orcidid>https://orcid.org/0000-0003-4654-9296</orcidid><orcidid>https://orcid.org/0000-0001-5028-3457</orcidid></search><sort><creationdate>20211201</creationdate><title>Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy</title><author>Kallestad, Håvard ; Scott, Jan ; Vedaa, Øystein ; Lydersen, Stian ; Vethe, Daniel ; Morken, Gunnar ; Stiles, Tore Charles ; Sivertsen, Børge ; Langsrud, Knut</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c515t-9edb4c39ee57bf7d2df0c228e96ae7bc76a7ec437c6407faf28a40ee3c5707223</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Behavior modification</topic><topic>Behavioral health care</topic><topic>Care and treatment</topic><topic>Clinical trials</topic><topic>Cognitive Behavioral Therapy</topic><topic>Cognitive therapy</topic><topic>Humans</topic><topic>Insomnia</topic><topic>Insomnia and Psychiatric Disorders</topic><topic>Internet</topic><topic>Medical research</topic><topic>Medicine, Experimental</topic><topic>Mental health</topic><topic>Psychiatric services</topic><topic>Sleep</topic><topic>Sleep Initiation and Maintenance Disorders - therapy</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kallestad, Håvard</creatorcontrib><creatorcontrib>Scott, Jan</creatorcontrib><creatorcontrib>Vedaa, Øystein</creatorcontrib><creatorcontrib>Lydersen, Stian</creatorcontrib><creatorcontrib>Vethe, Daniel</creatorcontrib><creatorcontrib>Morken, Gunnar</creatorcontrib><creatorcontrib>Stiles, Tore Charles</creatorcontrib><creatorcontrib>Sivertsen, Børge</creatorcontrib><creatorcontrib>Langsrud, Knut</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Sleep (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kallestad, Håvard</au><au>Scott, Jan</au><au>Vedaa, Øystein</au><au>Lydersen, Stian</au><au>Vethe, Daniel</au><au>Morken, Gunnar</au><au>Stiles, Tore Charles</au><au>Sivertsen, Børge</au><au>Langsrud, Knut</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy</atitle><jtitle>Sleep (New York, N.Y.)</jtitle><addtitle>Sleep</addtitle><date>2021-12-01</date><risdate>2021</risdate><volume>44</volume><issue>12</issue><spage>1</spage><pages>1-</pages><issn>0161-8105</issn><eissn>1550-9109</eissn><abstract>Abstract
Study Objectives
Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity.
Methods
Eligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33.
Results
Individuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was −2.8 (95% CI: −4.8 to −0.8; p = 0.007, Cohen’s d = 0.7), and −4.6 at week 9 (95% CI −6.6 to −2.7; p < 0.001), Cohen’s d = 1.2.
Conclusions
At the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I.
Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>34291808</pmid><doi>10.1093/sleep/zsab185</doi><orcidid>https://orcid.org/0000-0002-9173-942X</orcidid><orcidid>https://orcid.org/0000-0002-7203-8601</orcidid><orcidid>https://orcid.org/0000-0003-1972-5901</orcidid><orcidid>https://orcid.org/0000-0003-4654-9296</orcidid><orcidid>https://orcid.org/0000-0001-5028-3457</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Adult Behavior modification Behavioral health care Care and treatment Clinical trials Cognitive Behavioral Therapy Cognitive therapy Humans Insomnia Insomnia and Psychiatric Disorders Internet Medical research Medicine, Experimental Mental health Psychiatric services Sleep Sleep Initiation and Maintenance Disorders - therapy Treatment Outcome |
title | Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy |
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