Skip to main content
Top
Published in: Trials 1/2024

Open Access 01-12-2024 | Study protocol

Investigating the added effects of guidance in digital psychological self-care for alcohol problems (ALVA)—protocol for a randomized factorial optimization trial

Authors: Christopher Sundström, Ekaterina Ivanova, Philip Lindner, Magnus Johansson, Martin Kraepelien

Published in: Trials | Issue 1/2024

Login to get access

Abstract

Background

The continual development and implementation of effective digital interventions is one important strategy that may serve to bridge the well-known treatment gap related to problematic alcohol use. Research suggests that clinician guidance, provided in different ways during the digital intervention (i.e., written weekly messages, phone calls etc.), can boost intervention engagement and effects. Digital psychological self-care (DPSC) is a new delivery format wherein an unguided digital intervention is provided within the framework of a structured care process that includes initial clinical assessment and follow-up interviews. In a recent feasibility study, a DPSC intervention for problematic alcohol use, ALVA, provided without any extra guidance, was found safe and credible and to have promising within-group effects on alcohol consumption. The aim of the current study is to gather information on the effects and efficiency of different forms of guidance added to ALVA, in order to optimize the intervention.

Methods

This protocol describes a randomized factorial trial where the effects of two different ways of providing guidance (mid-treatment interview, weekly written messages, respectively) in DPSC for problematic alcohol use are investigated. Optimization criteria will be applied to the results regarding how effective the intervention is at reducing alcohol consumption measured by the number of standard drinks per week together with the clinician time spent on guidance.

Discussion

This study will investigate the added benefit of different forms of guidance to DPSC for problematic alcohol use. These added effects will be compared to the added cost of guidance, according to pre-defined optimization criteria.

Trial registration

Clinicaltrials.gov: NCT05649982. Registered on 06 December 2022. Prospectively registered.
Literature
1.
go back to reference Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, et al. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013;382(9904):1575–86.CrossRefPubMed Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, et al. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013;382(9904):1575–86.CrossRefPubMed
2.
go back to reference Mekonen T, Chan GCK, Connor J, Hall W, Hides L, Leung J. Treatment rates for alcohol use disorders: a systematic review and meta-analysis. Addiction. 2021;116(10):2617–34.CrossRefPubMed Mekonen T, Chan GCK, Connor J, Hall W, Hides L, Leung J. Treatment rates for alcohol use disorders: a systematic review and meta-analysis. Addiction. 2021;116(10):2617–34.CrossRefPubMed
3.
go back to reference Garnett CV, Crane D, Brown J, Kaner EFS, Beyer FR, Muirhead CR, et al. Behavior change techniques used in digital behavior change interventions to reduce excessive alcohol consumption: a meta-regression. Ann Behav Med. 2018;52(6):530–43.CrossRefPubMedPubMedCentral Garnett CV, Crane D, Brown J, Kaner EFS, Beyer FR, Muirhead CR, et al. Behavior change techniques used in digital behavior change interventions to reduce excessive alcohol consumption: a meta-regression. Ann Behav Med. 2018;52(6):530–43.CrossRefPubMedPubMedCentral
4.
go back to reference Riper H, Hoogendoorn A, Cuijpers P, Karyotaki E, Boumparis N, Mira A, et al. Effectiveness and treatment moderators of internet interventions for adult problem drinking: an individual patient data meta-analysis of 19 randomised controlled trials. Degenhardt L, editor. PLoS Med. 2018;15(12):e1002714.CrossRefPubMedPubMedCentral Riper H, Hoogendoorn A, Cuijpers P, Karyotaki E, Boumparis N, Mira A, et al. Effectiveness and treatment moderators of internet interventions for adult problem drinking: an individual patient data meta-analysis of 19 randomised controlled trials. Degenhardt L, editor. PLoS Med. 2018;15(12):e1002714.CrossRefPubMedPubMedCentral
5.
go back to reference Sundström C, Eék N, Kraepelien M, Fahlke C, Gajecki M, Jakobson M, et al. High- versus low-intensity internet interventions for alcohol use disorders: results of a three-armed randomized controlled superiority trial. Addiction. 2020;115(5):863–74.CrossRefPubMedPubMedCentral Sundström C, Eék N, Kraepelien M, Fahlke C, Gajecki M, Jakobson M, et al. High- versus low-intensity internet interventions for alcohol use disorders: results of a three-armed randomized controlled superiority trial. Addiction. 2020;115(5):863–74.CrossRefPubMedPubMedCentral
6.
go back to reference Blankers M, Koeter MWJ, Schippers GM. Internet therapy versus internet self-help versus no treatment for problematic alcohol use: A randomized controlled trial. J Consult Clin Psychol. 2011;79(3):330–41.CrossRefPubMed Blankers M, Koeter MWJ, Schippers GM. Internet therapy versus internet self-help versus no treatment for problematic alcohol use: A randomized controlled trial. J Consult Clin Psychol. 2011;79(3):330–41.CrossRefPubMed
7.
go back to reference Bischof G, Grothues JM, Reinhardt S, Meyer C, John U, Rumpf HJ. Evaluation of a telephone-based stepped care intervention for alcohol-related disorders: a randomized controlled trial. Drug Alcohol Depend. 2008;93(3):244–51.CrossRefPubMed Bischof G, Grothues JM, Reinhardt S, Meyer C, John U, Rumpf HJ. Evaluation of a telephone-based stepped care intervention for alcohol-related disorders: a randomized controlled trial. Drug Alcohol Depend. 2008;93(3):244–51.CrossRefPubMed
8.
go back to reference Araki I, Hashimoto H, Kono K, Matsuki H, Yano E. Controlled trial of worksite health education through face-to-face counseling vs. e-mail on drinking behavior modification. Jrnl of Occup. Health. 2006;48(4):239–45. Araki I, Hashimoto H, Kono K, Matsuki H, Yano E. Controlled trial of worksite health education through face-to-face counseling vs. e-mail on drinking behavior modification. Jrnl of Occup. Health. 2006;48(4):239–45.
9.
go back to reference Johansson M, Berman AH, Sinadinovic K, Lindner P, Hermansson U, Andréasson S. Effects of Internet-based cognitive behavioral therapy for harmful alcohol use and alcohol dependence as self-help or with therapist guidance: three-armed randomized trial. J Med Internet Res. 2021;23(11):e29666.CrossRefPubMedPubMedCentral Johansson M, Berman AH, Sinadinovic K, Lindner P, Hermansson U, Andréasson S. Effects of Internet-based cognitive behavioral therapy for harmful alcohol use and alcohol dependence as self-help or with therapist guidance: three-armed randomized trial. J Med Internet Res. 2021;23(11):e29666.CrossRefPubMedPubMedCentral
10.
go back to reference Sundström C, Schell C, Wardell JD, Godinho A, Cunningham JA. Can brief email guidance enhance the effects of an Internet intervention for people with problematic alcohol use? A randomized controlled trial. Subst Use Misuse. 2020;55(12):2011–9.CrossRefPubMed Sundström C, Schell C, Wardell JD, Godinho A, Cunningham JA. Can brief email guidance enhance the effects of an Internet intervention for people with problematic alcohol use? A randomized controlled trial. Subst Use Misuse. 2020;55(12):2011–9.CrossRefPubMed
11.
go back to reference Sundström C, Peynenburg V, Chadwick C, Thiessen D, Wilhems A, Nugent M, et al. Optimizing Internet-delivered cognitive behaviour therapy for alcohol misuse—a randomized factorial trial examining effects of a pre-treatment assessment interview and guidance. Addict Sci Clin Pract. 2022;17(1):37.CrossRefPubMedPubMedCentral Sundström C, Peynenburg V, Chadwick C, Thiessen D, Wilhems A, Nugent M, et al. Optimizing Internet-delivered cognitive behaviour therapy for alcohol misuse—a randomized factorial trial examining effects of a pre-treatment assessment interview and guidance. Addict Sci Clin Pract. 2022;17(1):37.CrossRefPubMedPubMedCentral
12.
go back to reference Johansson M, Sinadinovic K, Gajecki M, Lindner P, Berman AH, Hermansson U, et al. Internet-based therapy versus face-to-face therapy for alcohol use disorder, a randomized controlled non-inferiority trial. Addiction. 2020;13:15270. Johansson M, Sinadinovic K, Gajecki M, Lindner P, Berman AH, Hermansson U, et al. Internet-based therapy versus face-to-face therapy for alcohol use disorder, a randomized controlled non-inferiority trial. Addiction. 2020;13:15270.
13.
go back to reference Kraepelien M, Sundström C, Johansson M, Ivanova E. Digital psychological self-care for problematic alcohol use: feasibility of a new clinical concept. BJPsych open. 2023;9(3):e91.CrossRefPubMedPubMedCentral Kraepelien M, Sundström C, Johansson M, Ivanova E. Digital psychological self-care for problematic alcohol use: feasibility of a new clinical concept. BJPsych open. 2023;9(3):e91.CrossRefPubMedPubMedCentral
14.
go back to reference Titov N, Dear BF, Staples LG, Terides MD, Karin E, Sheehan J, et al. Disorder-specific versus transdiagnostic and clinician-guided versus self-guided treatment for major depressive disorder and comorbid anxiety disorders: a randomized controlled trial. J Anxiety Disord. 2015;35:88–102.CrossRefPubMed Titov N, Dear BF, Staples LG, Terides MD, Karin E, Sheehan J, et al. Disorder-specific versus transdiagnostic and clinician-guided versus self-guided treatment for major depressive disorder and comorbid anxiety disorders: a randomized controlled trial. J Anxiety Disord. 2015;35:88–102.CrossRefPubMed
15.
go back to reference Titov N, Dear BF, Johnston L, Lorian C, Zou J, Wootton B, et al. Improving adherence and clinical outcomes in self-guided internet treatment for anxiety and depression: randomised controlled trial. Andersson G, editor. PLoS One. 2013;8(7):e62873.ADSCrossRefPubMedPubMedCentral Titov N, Dear BF, Johnston L, Lorian C, Zou J, Wootton B, et al. Improving adherence and clinical outcomes in self-guided internet treatment for anxiety and depression: randomised controlled trial. Andersson G, editor. PLoS One. 2013;8(7):e62873.ADSCrossRefPubMedPubMedCentral
16.
go back to reference Kraepelien M, Hentati A, Kern D, Sundström C, Jernelöv S, Lindefors N. Transforming guided internet interventions into simplified and self-guided digital tools – experiences from three recent projects. Internet Interv. 2023;34:100693.CrossRefPubMedPubMedCentral Kraepelien M, Hentati A, Kern D, Sundström C, Jernelöv S, Lindefors N. Transforming guided internet interventions into simplified and self-guided digital tools – experiences from three recent projects. Internet Interv. 2023;34:100693.CrossRefPubMedPubMedCentral
17.
go back to reference Collins LM. Optimization of behavioral, biobehavioral, and biomedical interventions: the Multiphase Optimization Strategy (MOST) [Internet]. Cham: Springer International Publishing; 2018 [cited 2022 Jun 9]. (Statistics for Social and Behavioral Sciences). 10.1007/978-3-319-72206-1 Collins LM. Optimization of behavioral, biobehavioral, and biomedical interventions: the Multiphase Optimization Strategy (MOST) [Internet]. Cham: Springer International Publishing; 2018 [cited 2022 Jun 9]. (Statistics for Social and Behavioral Sciences). 10.1007/978-3-319-72206-1
18.
go back to reference Baker TB, Smith SS, Bolt DM, Loh WY, Mermelstein R, Fiore MC, et al. Implementing clinical research using factorial designs: a primer. Behav Ther. 2017;48(4):567–80.CrossRefPubMedPubMedCentral Baker TB, Smith SS, Bolt DM, Loh WY, Mermelstein R, Fiore MC, et al. Implementing clinical research using factorial designs: a primer. Behav Ther. 2017;48(4):567–80.CrossRefPubMedPubMedCentral
19.
go back to reference Saunders JB, Aasland OG, Babor TF, De La Fuente JR, Grant M. 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(6):791–804.CrossRefPubMed Saunders JB, Aasland OG, Babor TF, De La Fuente JR, Grant M. 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(6):791–804.CrossRefPubMed
20.
go back to reference Forsell E, Jernelöv S, Blom K, Kraepelien M, Svanborg C, Andersson G, et al. Proof of concept for an adaptive treatment strategy to prevent failures in Internet-delivered CBT: a single-blind randomized clinical trial with insomnia patients. Am J Psychiatry. 2019;176(4):315–23.CrossRefPubMed Forsell E, Jernelöv S, Blom K, Kraepelien M, Svanborg C, Andersson G, et al. Proof of concept for an adaptive treatment strategy to prevent failures in Internet-delivered CBT: a single-blind randomized clinical trial with insomnia patients. Am J Psychiatry. 2019;176(4):315–23.CrossRefPubMed
21.
go back to reference Svanborg P, Asberg M. A new self-rating scale for depression and anxiety states based on the Comprehensive Psychopathological Rating Scale. Acta Psychiatr Scand. 1994;89(1):21–8.CrossRefPubMed Svanborg P, Asberg M. A new self-rating scale for depression and anxiety states based on the Comprehensive Psychopathological Rating Scale. Acta Psychiatr Scand. 1994;89(1):21–8.CrossRefPubMed
22.
go back to reference American Psychiatric Association, American Psychiatric Association, editors. Diagnostic and statistical manual of mental disorders: DSM-5. 5th ed. Washington, D.C: American Psychiatric Association; 2013. p. 947.CrossRef American Psychiatric Association, American Psychiatric Association, editors. Diagnostic and statistical manual of mental disorders: DSM-5. 5th ed. Washington, D.C: American Psychiatric Association; 2013. p. 947.CrossRef
23.
go back to reference Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31(2):73–86.CrossRefPubMed Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31(2):73–86.CrossRefPubMed
24.
go back to reference Lindner P, Frykheden O, Forsström D, Andersson E, Ljótsson B, Hedman E, et al. The Brunnsviken Brief Quality of Life Scale (BBQ): development and psychometric evaluation. Cogn Behav Ther. 2016;45(3):182–95.CrossRefPubMedPubMedCentral Lindner P, Frykheden O, Forsström D, Andersson E, Ljótsson B, Hedman E, et al. The Brunnsviken Brief Quality of Life Scale (BBQ): development and psychometric evaluation. Cogn Behav Ther. 2016;45(3):182–95.CrossRefPubMedPubMedCentral
25.
go back to reference Flannery BA, Volpicelli JR, Pettinati HM. Psychometric properties of the Penn Alcohol Craving Scale. Alcohol Clin Exp Res. 1999;23(8):1289–95.CrossRefPubMed Flannery BA, Volpicelli JR, Pettinati HM. Psychometric properties of the Penn Alcohol Craving Scale. Alcohol Clin Exp Res. 1999;23(8):1289–95.CrossRefPubMed
27.
go back to reference Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092.CrossRefPubMed Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092.CrossRefPubMed
28.
go back to reference Heather N, Hönekopp J. A revised edition of the Readiness to Change Questionnaire [Treatment Version]. Addict Res Theory. 2008;16(5):421–33.CrossRef Heather N, Hönekopp J. A revised edition of the Readiness to Change Questionnaire [Treatment Version]. Addict Res Theory. 2008;16(5):421–33.CrossRef
29.
go back to reference Collins LM, Huang L, Dziak J. MOST: Multiphase Optimization Strategy_. R package version 0.1.0; 2017. Collins LM, Huang L, Dziak J. MOST: Multiphase Optimization Strategy_. R package version 0.1.0; 2017.
30.
go back to reference Bur OT, Krieger T, Moritz S, Klein JP, Berger T. Optimizing the context of support of web-based self-help in individuals with mild to moderate depressive symptoms: a randomized full factorial trial. Behav Res Ther. 2022;152:104070.CrossRefPubMed Bur OT, Krieger T, Moritz S, Klein JP, Berger T. Optimizing the context of support of web-based self-help in individuals with mild to moderate depressive symptoms: a randomized full factorial trial. Behav Res Ther. 2022;152:104070.CrossRefPubMed
31.
go back to reference Hedman E, Ljótsson B, Blom K, El Alaoui S, Kraepelien M, Rück C, et al. Telephone versus internet administration of self-report measures of social anxiety, depressive symptoms, and insomnia: psychometric evaluation of a method to reduce the impact of missing data. J Med Internet Res. 2013;15(10):e229.CrossRefPubMedPubMedCentral Hedman E, Ljótsson B, Blom K, El Alaoui S, Kraepelien M, Rück C, et al. Telephone versus internet administration of self-report measures of social anxiety, depressive symptoms, and insomnia: psychometric evaluation of a method to reduce the impact of missing data. J Med Internet Res. 2013;15(10):e229.CrossRefPubMedPubMedCentral
Metadata
Title
Investigating the added effects of guidance in digital psychological self-care for alcohol problems (ALVA)—protocol for a randomized factorial optimization trial
Authors
Christopher Sundström
Ekaterina Ivanova
Philip Lindner
Magnus Johansson
Martin Kraepelien
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-07981-6

Other articles of this Issue 1/2024

Trials 1/2024 Go to the issue