Does providing a brief internet intervention for hazardous alcohol use to people seeking online help for depression reduce both alcohol use and depression symptoms among participants with these co-occurring disorders? Study protocol for a randomised controlled trial

John A Cunningham, Christian S Hendershot, Frances Kay-Lambkin, Clayton Neighbors, Kathleen M Griffiths, Kylie Bennett, Anthony Bennett, Alexandra Godinho, Christina Schell, John A Cunningham, Christian S Hendershot, Frances Kay-Lambkin, Clayton Neighbors, Kathleen M Griffiths, Kylie Bennett, Anthony Bennett, Alexandra Godinho, Christina Schell

Abstract

Introduction: Hazardous alcohol consumption is common among people experiencing depression, often acting to exacerbate depressive symptoms. While many people with these co-occurring disorders do not seek face-to-face treatment, they do seek help online. There are effective internet interventions that target hazardous alcohol consumption or depression separately but none that combine these online interventions without the involvement of a therapist. In order to realise the potential of internet interventions, we need to develop an evidence base supporting the efficacy of internet interventions for co-occurring depression and hazardous alcohol use without any therapist involvement. This study aims to evaluate the effects on drinking, and on depressive symptoms, of combining an internet intervention targeting hazardous alcohol consumption with one for depression.

Methods and analysis: A double blinded, parallel group randomised controlled trial will be used. Participants with current depression who also drink in a hazardous fashion (n=986) will be recruited for a study to 'help improve an online intervention for depression'. Participants will be randomised either to receive an established online intervention for depression (MoodGYM) or to receive MoodGYM plus a brief internet intervention for hazardous alcohol consumption (Check Your Drinking; CYD). Participants will be contacted 3 and 6 months after receiving the interventions to assess changes in drinking and depression symptoms. It is predicted that participants receiving the CYD intervention in addition to MoodGYM will report greater postintervention reductions in alcohol consumption and depressive symptoms compared with those who received MoodGYM only. Hypothesised mediation and moderation effects will also be investigated. Using an intention-to-treat basis for the analyses, the hypotheses will be tested using a generalised linear hypothesis framework, and longitudinal analyses will use either generalised linear mixed modelling or generalised estimating equation approach where appropriate.

Ethics and dissemination: This research comprises the crucial first steps in developing lower-cost and efficacious internet interventions for people suffering from depression who also drink in a hazardous fashion-promoting the widespread availability of care for those in need. This study has been approved by the standing ethics review committee of the Centre for Addiction and Mental Health, and findings will be disseminated in the form of at least one peer-reviewed article and presentations at conferences.

Trial registration number: NCT03421080; Pre-results.

Keywords: brief intervention; clinical trial; comorbidity; depression; hazardous alcohol use; internet intervention; problem drinking; randomized controlled trial; trial protocol.

Conflict of interest statement

Competing interests: KB and AB are owners and employees of eHub Health Pty Ltd which has a commercial license to deliver the interventions. KMG is entitled to a share of royalties generated by the commercialisation of MoodGYM. The authors declare that they have no other competing interest.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Overview of the proposed intervention trial.

References

    1. Bolton JM, Robinson J, Sareen J. Self-medication of mood disorders with alcohol and drugs in the National Epidemiologic Survey on Alcohol and Related Conditions. J Affect Disord 2009;115:367–75. 10.1016/j.jad.2008.10.003
    1. Quello SB, Brady KT, Sonne SC. Mood disorders and substance use disorder: a complex comorbidity. Sci Pract Perspect 2005;3:13–21. 10.1151/spp053113
    1. Davis LL, Frazier E, Husain MM, et al. . Substance use disorder comorbidity in major depressive disorder: a confirmatory analysis of the STAR*D cohort. Am J Addict 2006;15:278–85. 10.1080/10550490600754317
    1. Kay Lambkin FJ. Lifetime Affective and Alcohol Use Disorder: Impact of Comorbidity on Current Functioning and Service Use in a Rural Population. J Addict Res Ther 2014;s10 10.4172/2155-6105.S10-009
    1. Baker AL, Kavanagh DJ, Kay-Lambkin FJ, et al. . Randomized controlled trial of cognitive-behavioural therapy for coexisting depression and alcohol problems: short-term outcome. Addiction 2010;105:87–99. 10.1111/j.1360-0443.2009.02757.x
    1. Kohn R, Saxena S, Levav I, et al. . The treatment gap in mental health care. Bull World Health Organ 2004;82:858–66.
    1. Clarkin JF, Kendall PC. Comorbidity and treatment planning: summary and future directions. J Consult Clin Psychol 1992;60:904–8. 10.1037/0022-006X.60.6.904
    1. Kaltenthaler E, Parry G, Beverley C, et al. . Computerised cognitive-behavioural therapy for depression: systematic review. Br J Psychiatry 2008;193:181–4. 10.1192/bjp.bp.106.025981
    1. Cuijpers P, van Straten A, Andersson G. Internet-administered cognitive behavior therapy for health problems: a systematic review. J Behav Med 2008;31:169–77. 10.1007/s10865-007-9144-1
    1. Bewick BM, Trusler K, Barkham M, et al. . The effectiveness of web-based interventions designed to decrease alcohol consumption–a systematic review. Prev Med 2008;47:17–26. 10.1016/j.ypmed.2008.01.005
    1. Cunningham JA, Humphreys K, Koski-Jännes A. Providing personalized assessment feedback for problem drinking on the Internet: a pilot project. J Stud Alcohol 2000;61:794–8. 10.15288/jsa.2000.61.794
    1. Cunningham JA, Kypri K, McCambridge J. The use of emerging technologies in alcohol treatment. Alcohol Res Health 2011;33:320–6.
    1. Kay-Lambkin FJ, Baker AL, Lewin TJ, et al. . Computer-based psychological treatment for comorbid depression and problematic alcohol and/or cannabis use: a randomized controlled trial of clinical efficacy. Addiction 2009;104:378–88. 10.1111/j.1360-0443.2008.02444.x
    1. Kay-Lambkin FJ, Baker AL, Kelly B, et al. . Clinician-assisted computerised versus therapist-delivered treatment for depressive and addictive disorders: a randomised controlled trial. Med J Aust 2011;195:S44–50.
    1. Deady M, Mills KL, Teesson M, et al. . An Online Intervention for Co-Occurring Depression and Problematic Alcohol Use in Young People: Primary Outcomes From a Randomized Controlled Trial. J Med Internet Res 2016;18:e71 10.2196/jmir.5178
    1. Geisner IM, Varvil-Weld L, Mittmann AJ, et al. . Brief web-based intervention for college students with comorbid risky alcohol use and depressed mood: does it work and for whom? Addict Behav 2015;42:36–43. 10.1016/j.addbeh.2014.10.030
    1. Nolen-Hoeksema S, Desrosiers A, Wilsnack SC. Predictors of alcohol-related problems among depressed and non-depressed women. J Affect Disord 2013;150:967–73. 10.1016/j.jad.2013.05.022
    1. Foster DW, Young CM, Steers M, et al. . Tears in your beer: Gender differences in coping drinking motives, depressive symptoms and drinking. Int J Ment Health Addict 2014;12:730–46. 10.1007/s11469-014-9504-3
    1. Aneshensel CS, Huba GJ. Depression, alcohol use, and smoking over one year: a four-wave longitudinal causal model. J Abnorm Psychol 1983;92:134–50. 10.1037/0021-843X.92.2.134
    1. Hartka E, Johnstone B, Leino EV, et al. . A meta-analysis of depressive symptomatology and alcohol consumption over time. Br J Addict 1991;86:1283–98. 10.1111/j.1360-0443.1991.tb01704.x
    1. Kwon TY, Kahng SK, Kim H. The Reciprocal Relationship between Depressive Symptoms and Alcohol Consumption: Group Comparison by Employment Status. Asian Social Work and Policy Review 2010;4:43–56. 10.1111/j.1753-1411.2009.00036.x
    1. Holahan CJ, Moos RH, Holahan CK, et al. . Drinking to cope and alcohol use and abuse in unipolar depression: a 10-year model. J Abnorm Psychol 2003;112:159–65. 10.1037/0021-843X.112.1.159
    1. Young CM, Neighbors C, DiBello AM, et al. . Coping Motives Moderate Efficacy of Personalized Normative Feedback Among Heavy Drinking U.S. College Students. J Stud Alcohol Drugs 2016;77:495–9. 10.15288/jsad.2016.77.495
    1. Young CM, Pedersen ER, Pearson AD, et al. . Drinking to Cope Moderates the Efficacy of Changing Veteran Drinking Norms as a Strategy for Reducing Drinking among U. S. Veterans. Psychol Addict Behav in press.
    1. Kessler RC, McGonagle KA, Swartz M, et al. . Sex and depression in the National Comorbidity Survey. I: Lifetime prevalence, chronicity and recurrence. J Affect Disord 1993;29:85–96. 10.1016/0165-0327(93)90026-G
    1. Nolen-Hoeksema S. Gender differences in depression Hammen I, Handbook of depression. New York: Guilford Press, 2002:492–509.
    1. Merrill JE, Reid AE, Carey MP, et al. . Gender and depression moderate response to brief motivational intervention for alcohol misuse among college students. J Consult Clin Psychol 2014;82:984–92. 10.1037/a0037039
    1. Cunningham JA, Kypri K, McCambridge J. Exploratory randomized controlled trial evaluating the impact of a waiting list control design. BMC Med Res Methodol 2013;13:150 10.1186/1471-2288-13-150
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001;16:606–13.
    1. Saunders JB, Aasland OG, Babor TF, et al. . Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on early detection of persons with Harmful Alcohol Consumption–II. Addiction 1993;88:791–804. 10.1111/j.1360-0443.1993.tb02093.x
    1. Babor TF, De La Fuente MF, Saunders JB, et al. . AUDIT - The alcohol use disorders identification test: Guidelines for use in primary health care. Geneva, Switzerland: World Health Organization, 1989.
    1. National Institute on Alcohol Abuse and Alcoholism. Helping patients who drink too much: A clinician’s guide. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism, 2005.
    1. Bennett K, Reynolds J, Christensen H, et al. . e-hub: an online self-help mental health service in the community. Med J Aust 2010;192:S48–52.
    1. Calear AL, Christensen H, Mackinnon A, et al. . The YouthMood Project: a cluster randomized controlled trial of an online cognitive behavioral program with adolescents. J Consult Clin Psychol 2009;77:1021–32. 10.1037/a0017391
    1. Christensen H, Griffiths KM, Jorm AF. Delivering interventions for depression by using the internet: randomised controlled trial. BMJ 2004;328:265–8. 10.1136/
    1. Griffiths KM, Christensen H, Jorm AF, et al. . Effect of web-based depression literacy and cognitive-behavioural therapy interventions on stigmatising attitudes to depression: randomised controlled trial. Br J Psychiatry 2004;185:342–9. 10.1192/bjp.185.4.342
    1. Hickie IB, Davenport TA, Luscombe GM, et al. . Practitioner-supported delivery of internet-based cognitive behaviour therapy: evaluation of the feasibility of conducting a cluster randomised trial. Med J Aust 2010;192:S31–S35.
    1. Høifødt RS, Lillevoll KR, Griffiths KM, et al. . The clinical effectiveness of web-based cognitive behavioral therapy with face-to-face therapist support for depressed primary care patients: randomized controlled trial. J Med Internet Res 2013;15:e153 10.2196/jmir.2714
    1. Mackinnon A, Griffiths KM, Christensen H. Comparative randomised trial of online cognitive-behavioural therapy and an information website for depression: 12-month outcomes. Br J Psychiatry 2008;192:130–4. 10.1192/bjp.bp.106.032078
    1. O’Kearney R, Kang K, Christensen H, et al. . A controlled trial of a school-based Internet program for reducing depressive symptoms in adolescent girls. Depress Anxiety 2009;26:65–72. 10.1002/da.20507
    1. Phillips R, Schneider J, Molosankwe I, et al. . Randomized controlled trial of computerized cognitive behavioural therapy for depressive symptoms: effectiveness and costs of a workplace intervention. Psychol Med 2014;44:741–52. 10.1017/S0033291713001323
    1. Powell J, Hamborg T, Stallard N, et al. . Effectiveness of a web-based cognitive-behavioral tool to improve mental well-being in the general population: randomized controlled trial. J Med Internet Res 2012;15:e2 10.2196/jmir.2240
    1. Sethi S. Treating Youth Depression and Anxiety: A Randomised Controlled Trial Examining the Efficacy of Computerised versus Face-to-face Cognitive Behaviour Therapy. Aust Psychol 2013;48:249–57. 10.1111/ap.12006
    1. Cunningham JA, Wild TC, Cordingley J, et al. . A randomized controlled trial of an internet-based intervention for alcohol abusers. Addiction 2009;104:2023–32. 10.1111/j.1360-0443.2009.02726.x
    1. Cunningham JA, Koski-Jännes A, Wild TC, et al. . Treating alcohol problems with self-help materials: a population study. J Stud Alcohol 2002;63:649–54. 10.15288/jsa.2002.63.649
    1. Doumas DM, Hannah E. Preventing high-risk drinking in youth in the workplace: a web-based normative feedback program. J Subst Abuse Treat 2008;34:263–71. 10.1016/j.jsat.2007.04.006
    1. Doumas DM, Haustveit T. Reducing heavy drinking in intercollegiate athletes: evaluation of a web-based personalized feedback program. Sport Psychol 2008;22:212–28. 10.1123/tsp.22.2.212
    1. Doumas DM, McKinley LL, Book P. Evaluation of two Web-based alcohol interventions for mandated college students. J Subst Abuse Treat 2009;36:65–74. 10.1016/j.jsat.2008.05.009
    1. Cunningham JA, Murphy M, Hendershot CS. Treatment dismantling pilot study to identify the active ingredients in personalized feedback interventions for hazardous alcohol use: randomized controlled trial. Addict Sci Clin Pract 2014;10:1 10.1186/s13722-014-0022-1
    1. Cunningham JA, Godinho A, Kushnir V. Can Amazon’s Mechanical Turk be used to recruit participants for internet intervention trials? A pilot study involving a randomized controlled trial of a brief online intervention for hazardous alcohol use. Internet Interv 2017;10:12–16. 10.1016/j.invent.2017.08.005
    1. Schmidt S, Mühlan H, Power M. The EUROHIS-QOL 8-item index: psychometric results of a cross-cultural field study. Eur J Public Health 2006;16:420–8. 10.1093/eurpub/cki155
    1. Saunders JB, Conigrave KM. Early identification of alcohol problems. CMAJ 1990;143:1060–9.
    1. Romelsjö A, Leifman H, Nyström S. A comparative study of two methods for the measurement of alcohol consumption in the general population. Int J Epidemiol 1995;24:929–36. 10.1093/ije/24.5.929
    1. Kühlhorn E, Leifman H. Alcohol surveys with high and low coverage rate: a comparative analysis of survey strategies in the alcohol field. J Stud Alcohol 1993;54:542–54. 10.15288/jsa.1993.54.542
    1. Neighbors C, Lewis MA, Atkins DC, et al. . Efficacy of web-based personalized normative feedback: a two-year randomized controlled trial. J Consult Clin Psychol 2010;78:898–911. 10.1037/a0020766
    1. Dawson DA, Grant BF, Stinson FS, et al. . Effectiveness of the derived Alcohol Use Disorders Identification Test (AUDIT-C) in screening for alcohol use disorders and risk drinking in the US general population. Alcohol Clin Exp Res 2005;29:844–54. 10.1097/01.ALC.0000164374.32229.A2
    1. Wechsler H, Davenport A, Dowdall G, et al. . Health and behavioral consequences of binge drinking in college. A national survey of students at 140 campuses. JAMA 1994;272:1672–7.
    1. Bertholet N, Daeppen JB, McNeely J, et al. . Smartphone application for unhealthy alcohol use: A pilot study. Subst Abus 2017;38:285–91. 10.1080/08897077.2017.1281860
    1. Bertholet N, Cunningham JA, Faouzi M, et al. . Internet-based brief intervention for young men with unhealthy alcohol use: a randomized controlled trial in a general population sample. Addiction 2015;110:1735–43. 10.1111/add.13051
    1. Grant BF, Moore TC, Shepard J, et al. . Source and Accuracy Statement. Wave 1 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). Bethesda, MD: National Institute on Alcohol Abuse and Alcoholism, 2003.
    1. Cooper ML. Motivations for alcohol use among adolescents: Development and validation of a four-factor model. Psychol Assess 1994;6:117–28. 10.1037/1040-3590.6.2.117
    1. Bondy SJ, Lange P. Measuring alcohol-related harm: test-retest reliability of a popular measure. Subst Use Misuse 2000;35:1263–75. 10.3109/10826080009147481
    1. Radloff LS. The CES-D scale: A self report depression scale for research in the general population. Applied Psychological Measurement 1977;1:385–401.
    1. Spitzer RL, Kroenke K, Williams JB, et al. . A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006;166:1092 10.1001/archinte.166.10.1092
    1. Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale–I. Item selection and cross-validation of the factor structure. J Psychosom Res 1994;38:23–32. 10.1016/0022-3999(94)90005-1
    1. Faul F, Erdfelder E, Lang AG, et al. . G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods 2007;39:175–91. 10.3758/BF03193146
    1. Cohen J. A power primer. Psychol Bull 1992;112:155–9. 10.1037/0033-2909.112.1.155
    1. Cohen J. Statistical power analysis for the behavioral sciences. Hillsdale, N.J: Lawrence Erlbaum Associates, 1988.
    1. Riper H, Blankers M, Hadiwijaya H, et al. . Effectiveness of guided and unguided low-intensity internet interventions for adult alcohol misuse: a meta-analysis. PLoS One 2014;9:e99912 10.1371/journal.pone.0099912
    1. Donker T, Bennett K, Bennett A, et al. . Internet-delivered interpersonal psychotherapy versus internet-delivered cognitive behavioral therapy for adults with depressive symptoms: randomized controlled noninferiority trial. J Med Internet Res 2013;15:e82 10.2196/jmir.2307
    1. White IR, Horton NJ, Carpenter J, et al. . Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ 2011;342:d40 10.1136/bmj.d40
    1. Fox J. Applied regression analysis and generalized linear models. 2nd ed Los Angeles: Sage, 2008.
    1. Atkins DC, Baldwin SA, Zheng C, et al. . A Tutorial on Count Regression and Zero-Altered Count Models for Longitudinal Substance Use Data (vol 27, pg 166, 2012). Psychol Addict Behav 2013;27:379–79.
    1. Duncan TE, Duncan SC, Strycker LA. An introduction to latent variable growth curve modeling: Concepts, issues, and application: Routledge Academic, 2013.
    1. Muthén B, Asparouhov T. Bayesian structural equation modeling: a more flexible representation of substantive theory. Psychol Methods 2012;17:313–35. 10.1037/a0026802
    1. Wang L, Preacher KJ. Moderated Mediation Analysis Using Bayesian Methods. Structural Equation Modeling: A Multidisciplinary Journal 2015;22:249–63. 10.1080/10705511.2014.935256
    1. Cohen J, Cohen P, West SG, et al. . Applied multiple regression/correlation analysis for the behavioral sciences. 2nd. ed: Routledge, 2013.

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