Optimizing and Innovating Blended Interventions and Aftercare for Alcohol Addiction (OptiBlend): A Randomized Controlled Trial

Traditionally, therapy for alcohol use disorder with or without substance use
disorder (A/SUD) therapy has been individual or group face-to-face (F2F)
therapy. Although these F2F programs are evidence-based, they suffer from a
number of shortcomings. Blended treatment combines the most valuable aspects of
digital and F2F treatments into one integrated protocol. Using this approach,
part of F2F treatment is replaced by digital components with digital therapist
feedback, while the F2F relationship between the therapist and patient is also
retained. F2F contact ensures that patients benefit from a supportive
therapeutic relationship, which likely increases motivation to complete
treatment. Digital elements, however, provide flexibility in time, allowing
patients to access treatment modules with most relevance to them in between F2F
sessions where therapist feedback is provided on exercises and other input
(Månsson et al., 2013). By extending access to treatment by providing online
sessions, the number of required F2F sessions can potentially be reduced, which
may result in cost-savings and reduced therapy waitlists. Mental healthcare
institutions are increasingly using blended treatment, and an evidence base has
emerged demonstrating clinical and cost-effectiveness of blended treatment for
many psychiatric disorders, but A/SUD studies addressing clinical and
cost-effectiveness of blended treatment are sparse and thus highly needed.

Cognitive behavioral therapy (CBT) is a protocolized treatment, in which
patients have F2F sessions with a psychologist. In between the sessions,
patients work on exercises in a workbook. There is a blended version of CBT, in
which patients have the F2F sessions with their therapist, and work on the
exercises in an online environment instead of in the workbook. In our study,
the online modules were updated: new modules about sleep and nutrition were
included, and the module on relapse prevention in the aftercare period was
expanded. By including an extensive interactive self-guided aftercare module,
the impact of the intervention can be extended in time, even with limited
efforts of a therapist. Incorporating transdiagnostic lifestyle modules (e.g.,
nutrition, sleeping), which would normally not be sufficiently covered in a F2F
A/SUD therapy program due to time constraints, likely improves the overall
impact of the intervention and patients* wellbeing. This new blended treatment
will be given in two forms: with 14 F2F sessions in BL1 and 8 F2F sessions in
BL2. In BL2, if more F2F sessions are deemed necessary as based on the clinical
view of the practitioner, 14 F2F sessions will be given as well. These two
forms of blended treatment will be compared to each other and with a standard
F2F CBT treatment (treatment as usual: TAU).

Primary objective: In the RCT, we expect to find at least a small to medium (d>=.
35) between-group effect between BL1 and BL2 compared to TAU. In the EMA, we
expect to find at least a medium (d>=.6) between-group effect between the
BL1/BL2 and TAU patients with regard to improvement of sleep and healthy
nutrition. Secondary objectives: 1. We expect to find that BL2 is non-inferior
to BL1, taking into account a non-inferiority margin of 10%. 2. We expect to
find that BL2 is more attractive in terms of cost-effectiveness than BL1 and
TAU, also when taking into account the health sector costs perspective and the
wider societal perspective (e.g., productivity costs).

A multicenter, 3-arm, single-blind randomized controlled trial (RCT) will be
conducted to evaluate the effects and costs of an innovated blended treatment
with (BL2) and without (BL1) intensity-personalization and F2F TAU. Assessments
will take place at baseline (before randomization), and 3 months, 6 months, 12
months, and 18 months after randomization. A cost-effectiveness evaluation will
be performed in line with suggestions by CHEERS 2022 guidelines and the Dutch
guideline for economic evaluation, e.g., in agreement with the
intention-to-treat principle, with missing data addressed using multiple
imputation. The trial will be registered in the Dutch Trial Register after the
METC approval. The duration of the study is planned for 3.5 years (24 months
inclusion period and 3, 6, 12, 18 month follow-up).

Participants will be enrolled from four participating centers in the
Netherlands. A total of 298 patients (ca. 99 per trial arm) will be included,
with 90 patients (30 per trial arm) simultaneously participating in a nested
ecological momentary assessment (EMA) study. Trial arm allocation will be
performed in a 1:1:1 ratio using a stratification procedure to minimize
inter-group imbalances in trial site. As participants are invited to the EMA
study before the randomization to the RCT, equal distributions of the EMA
participants over the three trial arms can be expected. Randomization will be
performed digitally with Castor EDC randomization software.

Treatment as usual (TAU, comparator intervention): TAU is a manual-based
cognitive behavioural therapy and motivational interviewing (CBT/MI)
intervention, consisting of up to 14 individual F2F sessions. TAU is broadly
implemented in the Netherlands. Its effectiveness is supported by a number of
RCTs and reviews cited in the multidisciplinary guideline on alcohol treatment
(Dutra et al., 2008).

Investigational treatment, innovated blended intervention modules: Both
intervention groups (BL1 and BL2) receive the blended treatment with updated
versions of the TAU materials and additional add-on modules (comparable with an
e-learning). The modules include process support by a psychologist during the
F2F sessions. The content of the modules is based on existing internet-based
(guided) self-help materials developed by Arkin/Jellinek and is based on CBT/MI
and tailored to adult patients with a diagnosis of AUD and possible other SUD
diagnoses. The blended intervention has a per-protocol duration of 3-4 months +
aftercare module (i.e., no therapist involvement).

Investigational treatment reduced F2F intensity: The first intervention group
(BL1) will receive the updated blended treatment as described above with 14 F2F
sessions. The second intervention group (BL2) will receive this same treatment
with reduced F2F intensity, meaning that they receive 8 F2Fsessions when
possible Instead of the F2F sessions, the patients in the BL2 treatment arm
will do more of their treatment modules online, with the option of discussing
the content of these modules in the more limited F2F sessions. If 8 F2F
sessions are deemed too few as based on the clinical opinion of the
practitioner, patients will receive 14 F2F sessions in BL2 Patients in BL2 will
thus either receive the short or the long version of the blended treatment.
While the long version will consist of 14 weekly face to face sessions, the
short version will consist of only 8 weekly to biweekly sessions, complemented
with 6 online feedback sessions by the practitioner in the online platform.

Burden associated with participating in the RCT and the nested EMA is expected
to be negligible because the study is mainly conducted online in parallel to
participants* F2F treatment. All participants are asked to fill out a baseline
and four follow-up questionnaires, which will not take more than 45 minutes to
complete. EMA participants are asked to additionally answer a brief
questionnaire via a smartphone application for seven consecutive days (max.
three minutes per day) at three time points during the RCT. The risk associated
with participating in the study is expected to be negligible, because the
participants get an evidence-based and widely used psychological treatment
(cognitive behavioral treatment for addiction: TAU) or one of the updated,
blended versions of this same treatment with additional content (BL1/BL2).