The aim of the study is to reduce depression symptoms and alcohol intake simultaneously in a population of young adults with a depressive disorder and problematic alcohol use. For this study online CBT/MI based alcohol reduction self-help add-on…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
problematisch alcoholgebruik
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary research outcome is a treatment response variable: alcohol and
depression related measures that are combined into a composite score which
indicates if the intervention has been succesfull or not.
The treatment response is successful when all three criteria below are met:
1) men drink less than 21 glasses and women less than 14 glasses of alcohol per
week in the week prior to measurement;
2) 0 days of 4 or more glasses of alcohol for women or 5 or more glasses of
alcohol for men in the last seven days;
3) a CES-D (depression) score of <16 or a reduction of 40% in comparison with
the CES-D score measured at baseline.
Secondary outcome
There are three secondairy outcome measures in this study:
1) Alcohol use
2) Depression symptoms
3) Quality of live
Furthermore, an economic evaluation will be performed alongside the RCT, to
test for cost-effectiveness of the intervention compared to care as usual.
Background summary
Problematic alcohol use often co-occurs with major depressive disorder (MDD),
both in treatment populations (Schuckit, 2006) as well as in the general
population (Boschloo et al 2011). MDD treatment populations have up to 40%
life-time probability of developing problematic alcohol use (Cranford et al
2011). The co-occurrence of problematic alcohol use and MDD results in even
greater disease burden and higher societal costs than the separate disorders
(Gadermann et al 2012; Riper et al 2014).
Various studies have shown that often MDD tends to occur prior to alcohol use
disorder (Briere et al 2014; Boschloo et al 2011; Kuo et al 2006). Briere et al
(2014) found MDD in early adulthood to predict alcohol problems in adulthood.
Furthermore, comorbidity more than doubled the risk of alcohol problem
severity. Also consistent with previous studies it was found that comorbidity
is associated with poorer functioning and life satisfaction than pure MDD
/problematic alcohol use (Briere et al 2014). Whether and how treatment should
be modified in cases of successive comorbidity is an understudied area that
requires further attention. Intervening in MDD early adulthood may help to
prevent subsequent alcohol use disorder (Briere et al 2014).
A recent review on alcohol use and depression among adolescents and young
adults also concludes that there is evidence supporting the association between
MDD and problem drinking, such that mood problems contribute to the onset of
alcohol problems, and that this association is bi-directional. To date,
findings suggest the critical need to reduce any alcohol use at a young age and
to address both depression and problematic alcohol use to prevent the
occurrence of comorbid disorders (Pedrelli et al 2016).
Combined treatment of comorbid alcohol problems and MDD could hence be vitally
important from a clinical and a public health viewpoint (Riper et al 2014),
especially for adolescents and young adults. Combined treatment has never been
common clinical practice as the comorbid disorder was either not recognized or
was not treated, assuming that it would resolve once the primary disorder was
treated effectively (Pettinati et al 2013).
Today, a growing number of combined treatments for comorbid problematic alcohol
use and MDD are available; these include psychotherapeutic treatments either as
an adjunct to treatment as usual (TAU) or as an alternative to it. Based on a
recent systematic review, there is some evidence that these combined
interventions can be effective for adults (Riper et al 2014). This review
concludes that combined cognitive-behavioural therapy (CBT) and motivational
interviewing (MI) for (sub-) clinical depression and problematic drinking has a
clinically significant effect in treatment outcomes (g=.17 for alcohol; g=.27
for depression) compared with treatment as usual. In this review, digital
interventions showed a higher effect size for depression than face-to-face
interventions (g=.73 vs. g=.23, P=.03).
For problem drinking, there is no evidence that digital interventions have an
effect size that differs from face-to-face interventions. For patients with
both MDD and problematic alcohol use patterns, combined treatment can reduce
symptoms, increase life satisfaction and quality of life, and may increase
patients* treatment satisfaction to a greater extent than single
disorder-focussed treatment (see Riper et al 2014). Thus, combined treatments
may also be more cost-effective than single disorder-focussed treatment (Schaub
et al 2016).
However, evidence on the effectiveness, and the availability of combined
depression and alcohol interventions tailored at young people is currently
insufficient.
Study objective
The aim of the study is to reduce depression symptoms and alcohol intake
simultaneously in a population of young adults with a depressive disorder and
problematic alcohol use. For this study online CBT/MI based alcohol reduction
self-help add-on modules tailored for young people in depression therapy will
be developed. In a multicentre randomized clinical trial effectiveness of
treatment as usual + internet-based alcohol reduction self-help add-on modules
on alcohol and depression outcomes against treatment as usual (TAU) will be
evaluated. In addition, an economic evaluation will be performed alongside the
RCT.
Study design
Multicenter, single blind, 2-arm randomized controlled trial.
Intervention
The online selfhelp consists of six online alcohol reduction 'add-on' modules
and will be based on existing (guided) selfhelp for alcohol use reduction from
Arkin/Jellinek. The alcohol modules will be based on cognitive behavior therapy
and motivational interviewing en will be tailered to young adults in depression
treatment (including students). Although the modules will mainly be selfhelp, a
light level of support will be available (e.g. personal feedback on assignments
by a coach (no care related taks)). Each module will consist of assignments and
psycho-education. Each module will take about 45 minutes to complete. De
following theme's will be included:
module 1: (dis)advantages of alcohol use and (dis)advantages of changing
alcohol drinking behavior and motivation for change
module 2: self-control measures
module 3: setting drinking goals
module 4: making an emergency plan when someone drank more than was allowed
according to their drinking goals
module 5: handling cravings, alcohol refusal skills
module 6: aftercare module (without support) continuing registration of alcohol
use and reference to support/selfhelp groups
Study burden and risks
Expectation of burden:
All participants will be asked to fill out one online baseline questionniare
and three follow-up online questionnaires. Filling out the questionnaire will
take about 45 minutes per questionniare.
Participants who are included in the intervention group will be asked to follow
the online selfhelp alcohol reduction modules. The six online alcohol modules
consist of pscyho-education and assignments according to specific alcohol
related themes. It will take about 45 minutes to complete the module and its
assignments.
Expecation of associated risks:
The expected risk concerning participation in this study are expected to be
negligible. Possible risk for paticipants that follow the online alcohol
modules could entail mild withdrawal symptoms such as craving. Furthermore, all
participants are asked to fill out the follow-up questionnaires
and/registration of alcohol intake. Therefore, they might could be more aware
of negative feelings concerning alcohol intake or if they relapsed.
Participants that follow the online alcohol modules will receive tips about how
to handle cravings and how to deal with situations in which they drink more
alcohol than they should.
Klaprozenweg 111
Amsterdam 1033 NN
NL
Klaprozenweg 111
Amsterdam 1033 NN
NL
Listed location countries
Age
Inclusion criteria
Depressive disorder as a diagnosis
Age 18-35
AUDIT score of *8 for men and *5 for women
Moderately proficient in Dutch
Willing to provide contact details including (mobile)phone
Healthcare insurance coverage
Computer/tablet at home and willingness to use this for research purposes
Informed consent regarding the study provided by the patient
Exclusion criteria
Acute psychosis
Alcohol dependence (DSM-4) or severe alcohol use disorder (DSM-5) as primary
diagnosis
Dementia
Waitlisted for in-patient mental health care
Pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL66899.100.18 |