Efficacy of an internet-based self-help intervention to reduce co-occurring alcohol misuse and depression symptoms in adults: study protocol of a three-arm randomised controlled trial

Abstract

IntroductionIn the general population, alcohol use disorder and depression more often occur together than any other combination of a mental illness with a substance use disorder. It is important to have a cost-effective intervention that is able to reach at-risk individuals in the early stages of developing alcohol use disorders and depression disorders.Methods and analysisThis paper presents the protocol for a 3-arm multicentre randomised controlled trial (RCT) to test the efficacy and cost-effectiveness of the combined internet-based self-help intervention Take Care of You (TCOY) to reduce alcohol misuse and depression symptoms in comparison with a waiting list control group and a comparable intervention focusing on problematic alcohol use only. The active interventions consist of modules designed to reduce alcohol use, based on the principles of motivational interviewing and methods of cognitive behavioural therapy, together with additional modules in the combined study arm to reduce symptoms of depression. Data will be collected at baseline, as well as at 3 and 6 months postrandomisation. The primary outcome is the quantity of alcohol used in the past 7 days. A number of secondary outcome measures will be studied. These include the Centre of Epidemiologic Studies of Depression Scale (CES-D) and a combined measure with the criteria of values below the cut-off for severe alcohol use disorder and for CES-D. Data analysis will follow the intention-to-treat principle using (generalised) linear mixed models. In order to investigate the interventions’ cost-utility and cost-effectiveness, a full economic evaluation will be performed.Ethics and disseminationThis RCT will be executed in compliance with the Helsinki Declaration and has been approved by 2 local Ethics Committees. Results will be reported at conferences and in peer-reviewed publications. Participant-friendly summaries of trial findings will be published on the TCOY websites.Trial registration numberISRCTN10323951.

Efficacy of an Online Self-Help Treatment for Comorbid Alcohol Misuse and Emotional Problems in Young Adults: Protocol for a Randomized Controlled Trial (Preprint)

“…Standard drinks are defined as a 12oz can or bottle of beer, a 5oz glass of wine, or a 1.5oz shot of hard liquor. The TLFB has been shown to provide reliable and valid estimates of alcohol use and is widely used in basic [38] and treatment [27] studies.…”

“…Consistent with similar RCTs conducted in the field [6,27], the control group will receive links to websites that provide general psychoeducation about alcohol and mental illness. Therefore, the control group will be defined as having access to available online psychoeducational material.…”

“…This is because an online modality may be associated with reduced shame and stigma -which are known, persistent barriers to seeking treatment among substance abusers [26]. Third, online treatments offer the potential for early intervention [27,28]. Self-guided online interventions may be helpful during a period earlier in the risk pathway when young adults are experiencing moderate (but still subclinical) problems.…”

“…The current study will design and deliver an online self-help intervention for comorbid alcohol misuse and emotional problems in young adults (ages [18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35]. This intervention will contain strategies drawn from Cognitive Behavioural Therapy (CBT) and Motivational Interviewing (MI) -both evidence-based psychotherapies for alcohol misuse and depression/anxiety [11,12].…”

Feasibility and Effects of Digital Interventions to Support People in Recovery From Substance Use Disorders: Systematic Review (Preprint)

“…But rates of use of the interventions dropped very quickly; for example, from 7,3 to 1,3 log ins each week during the first 3 months in the intervention studied by Campbell [58], or to 18% after six weeks in the interventions studied by Schaub [76,77]. Two interventions had higher rates of use; one reporting a drop from 63% completing the first module to 48% completing the last module, during the three weeks intervention [73], and a second reporting that one average the participants completed 7,7 of the 8 sessions in the intervention [44].…”