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Article: Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial

TitleTreating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial
Authors
KeywordsMajor depression
Insomnia
Cognitive behavioral therapy for insomnia
Sleep disturbance
Smartphone
Issue Date2020
PublisherBioMed Central Ltd. The Journal's web site is located at http://www.trialsjournal.com/
Citation
Trials, 2020, v. 21, p. article no. 843 How to Cite?
AbstractBackground: Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major depression and insomnia. Methods: A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow-up. The recruitment is completed. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I intervention. Discussion: It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby reducing the burden of the public healthcare system in Hong Kong. Trial registration: ClinicalTrials.gov NCT04228146. Retrospectively registered on 14 January 2020.
Persistent Identifierhttp://hdl.handle.net/10722/293148
ISSN
2023 Impact Factor: 2.0
2023 SCImago Journal Rankings: 0.812
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorHui, KYV-
dc.contributor.authorWong, CYF-
dc.contributor.authorMa, EKY-
dc.contributor.authorHo, FYY-
dc.contributor.authorChan, CS-
dc.date.accessioned2020-11-23T08:12:30Z-
dc.date.available2020-11-23T08:12:30Z-
dc.date.issued2020-
dc.identifier.citationTrials, 2020, v. 21, p. article no. 843-
dc.identifier.issn1745-6215-
dc.identifier.urihttp://hdl.handle.net/10722/293148-
dc.description.abstractBackground: Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major depression and insomnia. Methods: A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow-up. The recruitment is completed. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I intervention. Discussion: It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby reducing the burden of the public healthcare system in Hong Kong. Trial registration: ClinicalTrials.gov NCT04228146. Retrospectively registered on 14 January 2020.-
dc.languageeng-
dc.publisherBioMed Central Ltd. The Journal's web site is located at http://www.trialsjournal.com/-
dc.relation.ispartofTrials-
dc.rightsTrials. Copyright © BioMed Central Ltd.-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectMajor depression-
dc.subjectInsomnia-
dc.subjectCognitive behavioral therapy for insomnia-
dc.subjectSleep disturbance-
dc.subjectSmartphone-
dc.titleTreating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial-
dc.typeArticle-
dc.identifier.emailHui, KYV: vkyhui18@hku.hk-
dc.identifier.emailWong, CYF: cyfwong@hku.hk-
dc.identifier.emailChan, CS: shaunlyn@hku.hk-
dc.identifier.authorityChan, CS=rp01645-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1186/s13063-020-04778-1-
dc.identifier.pmid33036655-
dc.identifier.pmcidPMC7545384-
dc.identifier.scopuseid_2-s2.0-85092482609-
dc.identifier.hkuros319160-
dc.identifier.volume21-
dc.identifier.spagearticle no. 843-
dc.identifier.epagearticle no. 843-
dc.identifier.isiWOS:000578587800003-
dc.publisher.placeUnited Kingdom-

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