D(o)epression Blended as innovative e-mental health program for clinically depressed adolescents

Depressive disorders in adolescents are amongst the most prevalent disorders
with a high burden of disease and a high risk of recurrence or chronicity
(Birmaher, Brent, & AACAP Work Group on Quality Issues, 2007; Ryan, 2005).
Before adulthood, 14-25% of the adolescents has experienced an depressive
episode (Kessler & Walters, 1998). Additionally, depression shows high
comorbidity with other psychiatric diagnoses, and an elevated risk of social
problems, juridical problems, learning problems, school drop-out, decreased
academic performance, substance abuse, negative life events, physical problems,
teen pregnancies and suicide (Birmaher et al., 2007; Portzky & Van Heeringen,
2009; Ryan, 2005). Therefore, it is crucial that depressive disorders are
treated effectively in an early stage (Birmaher et al., 2007).
Cognitive Behavioral Therapy (CBT) is described as an effective intervention to
treat depression (Weisz, McCarty, & Valeri, 2006). However, a review found that
50% of the adolescents is not free of depressive symptoms after being treated
(Watanabe, Hunot, Omori, Churchill, & Furukawa, 2007). In a meta-analysis, the
effectsize of CBT was found to be moderate (d = 0.53) (Klein, Jacobs, &
Reinecke, 2007). A recent Dutch RCT investigating the effectiveness of the
D(o)epression protocol (face-to-face) has shown that CBT was moderately
effective compared to CAU (Stikkelbroek, 2016). Despite this, some adolescents
were not free of depressive symptoms at posttreatment (24%), the drop-out was
high (57%), and it was hard to motivate patients to finish the treatment.
Therefore, it seems important to develop an attractive and even more effective
treatment for adolescents. A recent meta-analysis showed that alternative
interventions (e.g. psychodynamic therapy, social skills training, supportive
counseling) are less effective than CBT, and that only IPT and Problem-solving
therapy are comparable to CBT (Barth et al., 2013). So using other treatments
does not seem to be the answer. Improving CBT does.
One improvement in CBT could be online sessions. Online intrevntions increase
motivation and treatment expectancies and decrease resistance and drop-out
because they can be tailored easily to the needs of adolescents and adjusted to
their daily lives (Gulliver, Griffiths, & Christensen, 2010). Another benefit
of online interventions is the high accessibility. Only 25% of the adolescents
who suffer from depression receives treatment, and improving access to
treatment is crucial (Makarushka, 2011). Online interventions increase
independence and self-confidence, strengthen own competences (Andrews,
Cuijpers, Craske, McEvoy, & Titov, 2010), and peer contact through online chat
improves social support (Van der Zanden, Kramer, Gerrits, & Cuijpers, 2012).
Furthermore, adolescents seem to prefer self-help, such as online
interventions (Gulliver et al., 2010).
A major benefit of online interventions for therapists is that they can easily
give feedback to their patients between face-to-face sessions. Also, less
face-to-face sessions are needed which in turn can decrease the therapist
workload of therapist and the duration of the waiting list (Andrews et al.,
2010), reducing societal cost (McCrone et al., 2004). A recent meta-analysis
and two reviews have shown that online CBT interventions are effective in
reducing depressive symptoms in adolescents (Ebert et al., 2015; Calear &
Christensen, 2010; Richardson, Stallard, & Velleman, 2010). In the Netherlands,
two online depression prevention programs for young adults (18-25) have shown
to be effective compared to a waiting list condition (Kramer, Conijn, Oijevaar,
& Riper, 2014; Van der Zanden et al., 2012). This shows that online depression
prevention programs are effective, but it is still unknown whether online
treatment programs for clinically depressed adolescents are effective. The
importance of guidance by a therapist in online interventions is shown by a
meta-analysis on computer-based psychological treatments for depression
(Richards & Richardson, 2012). In this meta-analysis, it was found that
interventions with guidance by a therapist are more effective than without
guidance. Moreover, therapeutic guidance in treatment of depression is
necessary because the suicide risk has to be monitored.
It can be concluded that blended treatment (online sessions and face-to-face
sessions) is preferred, but this type of treatment has hardly been studied in
clinically depressed adolescents (Riper, Van Ballegooijen, Kooistra, De Wit, &
Donker, 2013). Blended treatment is expected to be more effective, especially
in psychiatric care, because the benefits of face-to-face interventions are
combined with the benefits of online interventions. With this in mind, the
treatment protocol D(o)epression Blended is developed for treatment of
depressive disorders in adolescents (www.Doepressie-online.nl). D(o)epression
Blended might increase motivation, decrease resistance and reduce drop-out, and
therefore, it could be more effective than Doepression face-to-face and CAU.
D(o)epression Blended is attractive for adolescents because it can be tailored
easily to their treatment preferences and daily lives.
D(o)epression Blended is already frequently being used in treatment of
adolescents with depressive disorders, but the effectiveness has never been
studied before. Therefore, this study will examine the effectiveness and
cost-effectiveness of D(o)epression Blended and contribute to evidence-based
treatment of adolescents in psychiatric care. Besides examining the
effectiveness, several moderators (comorbidity, depression severity, age,
ethnicity, gender, family income, parental psychopathology) and mediators
(negative automatic thoughts, cognitive emotion regulation, attributional
style) will be examined to study for whom the intervention is effective and how
the intervention works.

Primary Objective:
Primary aim of this study is to evaluate the effectiveness and
cost-effectiveness of D(o)epression Blended in clinical practice in reducing
depressive symptoms and disorders in clinically depressed adolescents. The
modern and innovative D(o)epression Blended will be compared to D(o)epression
face-to-face and care as usual (CAU), of which the latter two conditions have
already been studied in an earlier RCT (NL34064.041.10).

Secondary Objective(s):
Secondary aim of this study is to examine for whom specifically D(o)epression
Blended is effective by testing moderators and individual trajectories of
change. Additionally, mediating effects will be studied. Further, drop-out will
be compared between D(o)epression Blended and D(o)epression face-to-face and
treatment us usual. Lastly, the feasibility and the expectancies adolescents
and therapists of Doepression blended will be studied.

Hypotheses:
1. D(o)epression Blended is more effective and costeffective than CAU.
2. D(o)epression Blended is equally effective as D(o)epression face-to-face.
3. D(o)epression Blended is more costeffective than D(o)epression face-to-face.
4. D(o)epression Blended will lead to a faster decrease in depressive symptoms
than D(o)epression face-to-face.
5. D(o)epression Blended will lead to less drop-out and lower costs because of
the reduction in face-to-face contacts.
6. Adolescents are more satisfied being treated with D(o)epression-blended than
with D(o)epression face-to-face.*

The presented study uses a quasi-experimental cohort design with one condition.
Additionally, data from a previous study will be used, in which an RCT was
conducted and D(o)epression face-to-face was compared to care as usual
(NL34064.041.10). Therefore, this cohort can be seen as a third additional
condition. Assessments and instruments will be identical to the previous study
comparing CBT with CAU. Participants in this study can, when necessary, be
compared to participants from the earlier executed RCT based on matching and
propensity scores (Bartak et al., 2008). Results of thisThe study will be
reported conducted according to the CONSORT Statement (Schulz, Altman, Moher, &
Consort Group, 2010).
Adolescents between 12 and 21 years old with a depressive disorder
referred for treatment and their parents will be asked to participate in this
study. Researchers will obtain informed consent before enrolling participants
in this study. All adolescents meeting the eligibility criteria and willing to
participate, will be assigned to the D(o)epression Blended intervention. Before
the start of the intervention, the baseline assessment will be executed.
Following assessments are during the intervention, after 5 weeks and after 10
weeks, post-intervention, 6-month and 12-month follow-up.

D(o)epression Blended (Stikkelbroek & Van Dijk, 2013) is a cognitive behavioral
treatment program based on the evidence-based treatment program Coping with
Depression course (Clarke, Lewinsohn, & Hops, 1990). D(o)epression Blended
consists of 4 online modules and a minimum of 5 face-to-face contacts of each
45 minutes between the adolescent and the therapist. Additionally, there is
unlimited email contact between the adolescent and therapist and there is a
weekly group chat.
During the face-to-face contacts, the new modules are introduced, the
therapeutic relationship is improved, exercises are practiced, the treatment is
tailored to the adolescent*s needs, and suicide risk is examined. Further,
there are two face-to-face contacts with parents; one after three weeks and one
after the start of the fourth module. Parents receive psycho-education,
information about cognitive behavioral therapy, and suggestions on how parents
can contribute to the treatment.
The content of D(o)epression Blended is equal to the face-to-face
intervention and consists of the following components: psycho-education,
setting realistic goals, self-monitoring, activation, improvement of social and
communication skills, relaxation skills, cognitive restructuring, role play,
problem solving skills and relapse prevention (Stikkelbroek, Bouman, &
Cuijpers, 2005). These components are divided into four online modules which
are offered sequentially and are called start, do, think and future. New
modules can only be started when the previous module is finished. The exercises
and registration of activities is completely online. The exercises are
introduced during the face-to-face contacts and are practiced online and at
home, this increases the generalizability to real life situations. The online
environment offers tremendous convenience and flexibility to which adolescents
can tailor their treatment preferences, such as pace, frequency, and location.
This means that blended treatment is vastly different from regular treatment
and allows to tailor the treatment to the preferences of each individual.

Adolescents, parents and therapists are burdened with filling out
questionnaires. In addition, a semi-structured interview (KSADS) will be
conducted with adolescents and parents The diagnostic interview and some of the
questionnaires are part of the standard procedure (diagnostic proces) of the
participating institutions. There are no risks involved in particpation in this
study.