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

Victoria Ka-Ying Hui, Christy Yim-Fan Wong, Eric Ka-Yiu Ma, Fiona Yan-Yee Ho, Christian S Chan, Victoria Ka-Ying Hui, Christy Yim-Fan Wong, Eric Ka-Yiu Ma, Fiona Yan-Yee Ho, Christian S Chan

Abstract

Background: 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.

Keywords: Cognitive behavioral therapy for insomnia; Insomnia; Internet intervention; Major depression; Sleep disturbance; Smartphone.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The current RCT study design
Fig. 2
Fig. 2
Proposed flow of participants

References

    1. Lee S, Tsang A, Kwok K. Twelve-month prevalence, correlates, and treatment preference of adults with DSM-IV major depressive episode in Hong Kong. J Affect Disord. 2007;98(1–2):129–136. doi: 10.1016/j.jad.2006.07.009.
    1. Tsuno N, Besset A, Ritchie K. Sleep and depression. J Clin Psychiatry. 2005;66(10):1254–1269. doi: 10.4088/JCP.v66n1008.
    1. Ford DE, Kamerow DB. Epidemiologic study of sleep disturbances and psychiatric disorders. An opportunity for prevention? JAMA. 1989;262(11):1479–1484. doi: 10.1001/jama.1989.03430110069030.
    1. Baglioni C, Battagliese G, Feige B, Spiegelhalder K, Nissen C, Voderholzer U, et al. Insomnia as a predictor of depression: a meta-analytic evaluation of longitudinal epidemiological studies. J Affect Disord. 2011;135(1–3):10–19. doi: 10.1016/j.jad.2011.01.011.
    1. Gregory AM, Rijsdijk F, Lau JYF, Dahl RE, Eley TC. The direction of longitudinal associations between sleep problems and depression symptoms: a study of twins aged 8 and 10 years. Sleep. 2009;32(2):189–199. doi: 10.1093/sleep/32.2.189.
    1. Li SX, Lam SP, Yu MWM, Zhang J, Wing YK. Nocturnal sleep disturbances as a predictor of suicide attempts among psychiatric outpatients: a clinical, epidemiologic, prospective study. J Clin Psychiatry. 2010;71(11):1440–1446. doi: 10.4088/JCP.09m05661gry.
    1. Gloaguen V, Cottraux J, Cucherat M, Blackburn I-M. A meta-analysis of the effects of cognitive therapy in depressed patients. J Affect Disord. 1998;49(1):59–72. doi: 10.1016/S0165-0327(97)00199-7.
    1. Thorndike FP, Ritterband LM, Gonder-Frederick LA, Lord HR, Ingersoll KS, Morin CM. A randomized controlled trial of an internet intervention for adults with insomnia: effects on comorbid psychological and fatigue symptoms. J Clin Psychol. 2013;69(10):1078–1093. doi: 10.1002/jclp.22032.
    1. Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, Lichstein KL. Psychological and behavioral treatment of insomnia: update of the recent evidence (1998-2004) Sleep. 2006;29(11):1398–1414. doi: 10.1093/sleep/29.11.1398.
    1. Staner L. Comorbidity of insomnia and depression. Sleep Med Rev. 2010;14(1):35–46. doi: 10.1016/j.smrv.2009.09.003.
    1. Manber R, Edinger JD, Gress JL, Pedro-Salcedo MGS, Kuo TF, Kalista T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. Sleep. 2008;31(4):489–495. doi: 10.1093/sleep/31.4.489.
    1. Hospital Authority. Waiting time for stable new case booking at specialist out-patient clinics 2019 Available from: . Accessed 6 Sept 2019.
    1. Mak WWS, Chong ESK, Wong CCY. Beyond attributions: understanding public stigma of mental illness with the common sense model. Am J Orthopsychiatry. 2014;84(2):173–181. doi: 10.1037/h0099373.
    1. Tsang HWH, Tam PKC, Chan F, Cheung WM. Stigmatizing attitudes towards individuals with mental illness in Hong Kong: implications for their recovery. J Community Psychol. 2003;31(4):383–396. doi: 10.1002/jcop.10055.
    1. Chung KF, Wong MC. Experience of stigma among Chinese mental health patients in Hong Kong. Psychiatr Bull. 2004;28(12):451–454. doi: 10.1192/pb.28.12.451.
    1. Kaltenthaler E, Sutcliffe P, Parry G, Beverley C, Rees A, Ferriter M. The acceptability to patients of computerized cognitive behaviour therapy for depression: a systematic review. Psychol Med. 2008;38(11):1521–1530. doi: 10.1017/S0033291707002607.
    1. Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M. Effectiveness of a novel integrative online treatment for depression (Deprexis): randomized controlled trial. J Med Internet Res. 2009;11(2):1–18. doi: 10.2196/jmir.1151.
    1. Blom K, Jernelöv S, Rück C, Lindefors N, Kaldo V. Three-year follow-up comparing cognitive behavioral therapy for depression to cognitive behavioral therapy for insomnia, for patients with both diagnoses. Sleep. 2017;40(8). 10.1093/sleep/zsx108.
    1. Ho FY-Y, Chan CS, Lo W-Y, Leung JC-Y. The effect of self-help cognitive behavioral therapy for insomnia on depressive symptoms: an updated meta-analysis of randomized controlled trials. J Affect Disord. 2020;265:287–304. doi: 10.1016/j.jad.2020.01.062.
    1. Ye Y-Y, Zhang Y-F, Chen J, Liu J, Li X-J, Liu Y-Z, et al. Internet-based cognitive behavioral therapy for insomnia (ICBT-i) improves comorbid anxiety and depression—a meta-analysis of randomized controlled trials. PLoS One. 2015;10(11):e0142258. doi: 10.1371/journal.pone.0142258.
    1. Zachariae R, Lyby MS, Ritterband LM, O'Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia—a systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016;30:1–10. doi: 10.1016/j.smrv.2015.10.004.
    1. Parker G, Cheah YC, Roy K. Do the Chinese somatize depression? A cross-cultural study. Soc Psychiatry Psychiatr Epidemiol. 2001;36(6):287–293. doi: 10.1007/s001270170046.
    1. Ho FY-Y, Chung K-F, Yeung W-F, Ng TH-Y, Cheng SK-W. Weekly brief phone support in self-help cognitive behavioral therapy for insomnia disorder: relevance to adherence and efficacy. Behav Res Ther. 2014;63:147–156. doi: 10.1016/j.brat.2014.10.002.
    1. Census and Statistics Department . Usage of information technology and the Internet by Hong Kong resident: 2000 to 2016. 2017.
    1. Wong WS, Fielding R. Prevalence of insomnia among Chinese adults in Hong Kong: a population-based study. J Sleep Res. 2011;20(1, Pt1):117–126. doi: 10.1111/j.1365-2869.2010.00822.x.
    1. Ni MY, Yao XI, Leung KSM, Yau C, Leung CMC, Lun P, et al. Depression and post-traumatic stress during major social unrest in Hong Kong: a 10-year prospective cohort study. Lancet. 2020;395(10220):273–284. doi: 10.1016/S0140-6736(19)33160-5.
    1. Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011;34(5):601–608. doi: 10.1093/sleep/34.5.601.
    1. Kroenke K, Spitzer RL, Williams JBW. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–613. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001;2(4):297–307. doi: 10.1016/S1389-9457(00)00065-4.
    1. Liu Y, Zhang J, Lam SP, Yu MWM, Li SX, Zhou J, et al. Help-seeking behaviors for insomnia in Hong Kong Chinese: a community-based study. Sleep Med. 2016;21:106–113. doi: 10.1016/j.sleep.2016.01.006.
    1. Yu DSF. Insomnia Severity Index: psychometric properties with Chinese community-dwelling older people. J Adv Nurs. 2010;66(10):2350–2359. doi: 10.1111/j.1365-2648.2010.05394.x.
    1. Yu X, Tam WWS, Wong PTK, Lam TH, Stewart SM. The Patient Health Questionnaire-9 for measuring depressive symptoms among the general population in Hong Kong. Compr Psychiatry. 2012;53(1):95–102. doi: 10.1016/j.comppsych.2010.11.002.
    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders. 5. Arlington: Author; 2013.
    1. Chan WC, Wong CSM, Chen EYH, Ng RMK, Hung SF, Cheung EFC, et al. Validation of the Chinese version of the Revised Clinical Interview Schedule: Findings from Hong Kong Mental Morbidity Survey. East Asian Arch Psychiatr. 2017;27(1):3–10.
    1. Ware JE, Kosinski M, Keller SD. SF-12: how to score the SF-12 physical and mental health summary scales. 2. Boston: The Health Institute, New England Medical Center; 1995.
    1. Gill SC, Butterworth P, Rodgers B, Mackinnon A. Validity of the mental health component scale of the 12-item Short-Form Health Survey (MCS-12) as measure of common mental disorders in the general population. Psychiatry Res. 2007;152(1):63–71. doi: 10.1016/j.psychres.2006.11.005.
    1. Morin CM, Espie CA. Insomnia: a clinician’s guide to assessment and treatment. New York: Kluwer Academic/Plenum Publishers; 2003.
    1. Herron C, York H, Corrie C, Cole SP. A comparison study of the effects of a story-based video instructional package versus a text-based instructional package in the intermediate-level foreign language classroom. CALICO J. 2006;23(2):281–307. doi: 10.1558/cj.v23i2.281-307.
    1. Juarascio AS, Goldstein SP, Manasse SM, Forman EM, Butryn ML. Perceptions of the feasibility and acceptability of a smartphone application for the treatment of binge eating disorders: qualitative feedback from a user population and clinicians. Int J Med Inform. 2015;84(10):808–816. doi: 10.1016/j.ijmedinf.2015.06.004.
    1. Oh J, Saraswathi B, Shyam SS. Clicking, assessing, immersing, and sharing: an empirical model of user engagement with interactive media. Commun Res. 2018;45(5):737–763. doi: 10.1177/0093650215600493.
    1. Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas. 1977;1(3):385–401. doi: 10.1177/014662167700100306.
    1. Chin WY, Choi EPH, Chan KTY, Wong CKH. The psychometric properties of the Center for Epidemiologic Studies Depression Scale in Chinese primary care patients: factor structure, construct validity, reliability, sensitivity and responsiveness. PLoS One. 2015;10(8):e0135131. doi: 10.1371/journal.pone.0135131.
    1. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213. doi: 10.1016/0165-1781(89)90047-4.
    1. Lau EYY, Hui CH, Cheung S-F, Lam J. Bidirectional relationship between sleep and optimism with depressive mood as a mediator: a longitudinal study of Chinese working adults. J Psychosom Res. 2015;79(5):428–34.
    1. Lam CLK, Tse EYY, Gandek B. Is the standard SF-12 Health Survey valid and equivalent for a Chinese population? Quality of Life Research: an International Journal of Quality of Life Aspects of Treatment. Care Rehabil. 2005;14(2):539–547.
    1. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67(6):361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Wong JY-H, Fong DY-T. Anxiety mediates the impact of stress on psychosomatic symptoms in Chinese. Psychol Health Med. 2015;20(4):457–468. doi: 10.1080/13548506.2014.951372.
    1. Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31(2):73–86. doi: 10.1016/S0005-7916(00)00012-4.
    1. Webb CA, Kertz SJ, Bigda-Peyton JS, Björgvinsson T. The role of pretreatment outcome expectancies and cognitive–behavioral skills in symptom improvement in an acute psychiatric setting. J Affect Disord. 2013;149(1–3):375–382. doi: 10.1016/j.jad.2013.02.016.
    1. Heim E, Rötger A, Lorenz N, Maercker A. Working alliance with an avatar: how far can we go with internet interventions? Internet Interv. 2018;11:41–46. doi: 10.1016/j.invent.2018.01.005.
    1. Ben-Zeev D, Brenner CJ, Begale M, Duffecy J, Mohr DC, Mueser KT. Feasibility, acceptability, and preliminary efficacy of a smartphone intervention for schizophrenia. Schizophr Bull. 2014;40(6):1244–1253. doi: 10.1093/schbul/sbu033.
    1. Ho FY-Y. Low intensity psychological intervention for common mental disorders. Hong Kong SAR: University of Hong Kong; 2017.
    1. Armijo-Olivo S, Warren S, Magee D. Intention to treat analysis, compliance, drop-outs and how to deal with missing data in clinical research: a review. Phys Ther Rev. 2009;14(1):36–49. doi: 10.1179/174328809X405928.

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