First web-based Dual Disorder Treatment Trial among Problematic Alcohol Users with Moderate Depression Symptoms

Web-based self-help programs that reduce problematic substance use are able to
reach *hidden* consumer groups in the general population who often fear
stigmatization. These programs are characterized by their low treatment
threshold, non-restrictive setting for intervention and remarkably positive
cost-benefit relation, which is of interest for both low-income and high-income
industrialized countries suffering from exorbitant health costs.

There is substantial co-occurrence of mental disorders and substance use
disorders. Prevalence of dual disorders, the condition of suffering from a
mental illness and a co-morbid substance abuse problem, is probably highest in
the general population for individuals with depression disorders and
problematic alcohol use. Co-morbidity of alcohol misuse and abuse is two to
three times higher for those who suffer from depression disorders compared to
the general population.

Internet-based self-help programs to reduce subclinical alcohol use disorders
or ameliorate moderate to mild depression symptoms have been reported to be
effective in meta-analyses. A cost-effective intervention that is able to reach
at-risk individuals in early stages of potentially more pronounced alcohol use
and depression disorders is of great importance from a public health point of
view.

Therefore we aim to develop the first web-based dual disorder self-help
intervention for harmful or hazardous alcohol users with mild to moderate
co-occurring depression symptoms and to test this intervention*s effectiveness
in a randomized controlled trial.

The objective will be to test the effectiveness of a web-based intervention
aiming to reduce alcohol consumption and depression symptoms combined, a
web-based self-help intervention focusing on problematic alcohol use only, and
a waiting list control condition in hazardous and harmful alcohol users with
co-morbid mild to moderate depression symptoms.

This study will be a three-arm randomized controlled trial that will test the
effectiveness of two web-based 6 weeks self-help interventions for reducing or
enabling the abstention from alcohol use in problematic users with depressive
symptoms. One intervention will focus on alcohol only while the other will
focus on alcohol and depression treatment combined. Total sample size is aimed
at 252 participants from the Netherlands (756 participants in total, from the
three participatingcountries). Follow-Ups will be assessed 3 and 6 month after
the individual*s self chosen starting point.

The study will comprise 3 arms:
1) Experimental Intervention 1: Web-based self-help program focused on alcohol
and depression
2) Experimental Intervention 2: Web-based self-help program focused on alcohol
3) Control Condition: Waiting list

Once participants have completed their baseline assessment, they will be
randomized by a computer program in a 1:1:1 ratio to 1 of 3 parallel groups.

We will test the following detailed study hypotheses with respect to the
reduction of the quantity of weekly standard drinks and depression symptoms
between the baseline and the 3 and 6 months follow-up:

1. Tailored self-help for the reduction of alcohol use and depression symptoms
(study arm 1) is more effective than the waiting list control condition (study
arm 3) in reducing alcohol use and depression symptoms.
2. Tailored self-help for the reduction of alcohol use (study arm 2) is more
effective than the waiting list control condition (study arm 3) in reducing
alcohol use but not depression symptoms.
3. Tailored self-help for the reduction of alcohol use and depression symptoms
(study arm 1) is more effective than self-help for the reduction of alcohol use
only (study arm 2) in the reduction of depression symptoms but not in the
reduction of alcohol use.

Data will be analysed according to the intention-to-treat principle (ITT). For
the ITT analyses, we will apply the multiple imputations procedure (MICE) of
STATA, which imputes missing data using all available baseline variables
(socio-demographic, health- and alcohol-related variables).

Baseline measurements will be compared using t- and Chi-squared tests.
Differences between primary and secondary outcome variables between baseline
and the follow-up will be tested using generalized estimating equation (GEE)
models.

All data inputs from participants is entered and accessed via 128bit encrypted
and password protected SSL-Connections over a website.

The web-based self-help intervention will consist of a diary and several
(currently 8) modules based on the principles of motivational interviewing,
self-control practices, and methods of cognitive behavioural therapy.

Participants can study all modules at their own pace and in their own order,
though a specific order will be advised.

In intervention 1 the diary will asses alcohol consumption, mood and positive
activities. The modules will focus on alcohol reduction and depression
treatment combined.

In intervention 2 the diary will assess alcohol consumption only. The modules
will focus on alcohol reduction only * though the length will approximately be
the same as in intervention 1.

The control condition is a waitinglist. After 6 months their study phase is
finished and they will be given the opportunity to start the self-help
programme of experimental condition 1.

Potential risks are expected to be minimal as no drugs or medical devices are
used. What we expect are withdrawal symptoms, like craving or depressive
resentments. These issues will be adressed in the psychoeducative modules which
are part of the 6 week selfhelp-intervention. At all time an *instant help*-
webpage is available with instructions what to do if the situation gets
unbearable. These instructions contain psychoeducative selfhelp instructions as
well as phone numbers to health care takers from the public sector.

The benefits of the intervention reach from a better understanding of one*s
addictive behaviour, through having some psychological tools to handle craving
and prevent relapses up to being released from alcohol dependency and/or
amelioration of depressive symptoms.