Internet-based emotion-regulation training in adolescents with depressive and anxiety disorders: a pilot randomized controlled trial of its feasibility and acceptability.

Anxiety and depressive disorders are common in children and adolescents
(Merikangas, Nakamura, & Kessler, 2009; Patel, Flisher, Hetrick, & McGorry,
2007). Among youths aged younger than 18 years, global prevalence rates are
estimated at 6.5% for anxiety disorders and 2.6% for depressive disorders
(Polanczyk, Salum, Sugaya, Caye, & Rohde, 2015). Prevalence of mental disorders
further increases during the transition from childhood to adolescence (see
Costello, Copeland, & Angold, 2011, for a review), with prevalence rates
estimated at 10.7% for anxiety disorders and 6.1% for depressive disorders in
adolescents aged between 12 and 19 years (Costello et al., 2011). During
adolescence, many mental disorders manifest for the first time (Lee et al.
2014; Patel et al., 2007). Sub threshold symptoms of anxiety and depression are
prevalent in adolescents as well: in a large European sample of adolescents
aged 14-16 years from 11 countries, 32% were sub threshold-anxious and 29.2%
were sub threshold depressed - with a higher prevalence for each additional
year (Balász et al., 2013). Both full-blown and subthreshold depressive and
anxiety disorders are more prevalent in girls than in boys (Hyde, Mezulis, &
Abrahamson, 2008; Balasz et al., 2013; Costello et al., 2003). The increased
prevalence in girls appears to develop after the age of 14 (Wade, Cairney, &
Prevalin, 2002).

Anxiety and depressive disorders negatively impact adolescents* social
functioning and educational achievements (Essau, Conradt, & Petermann, 2000;
Fletcher, 2010), employment rates (Jaycox et al., 2009; Keenan-Miller, Hammen,
& Brennan, 2007), nicotine dependence (McKenzie, Olsson, Jorm, Romaniuk, &
Patton, 2010) and general health (Keenan-Miller et al., 2007). In addition,
childhood anxiety and depressive disorders predict a range of mental health
problems in adulthood, including anxiety, depression, bipolar disorders, and
substance-use (Copeland, Shanaham, Costello, & Angold, 2009; Fergusson &
Woodward, 2002; Ferdinand, Blüm, & Verhulst, 2001; Merikangas et al., 2010;
Wolitzky-Taylor et al., 2014). Moreover, these disorders are associated with an
increased risk of suicide (Hawton, Saunders, & O'Connor, 2012): the second most
prevalent cause of death in adolescents (Patton et al., 2009). Given the high
prevalence and detrimental effects of anxiety and depressive disorders in
adolescents, it is of utmost importance to gain insight into potential
mechanisms underlying these disorders in this vulnerable group. Therefore, this
proposed study aims to examine the acceptability and feasibility of an add-on
emotion regulation training. Second, this study aims to provide a first
estimate of the potential effectiveness of adding an internet-based emotion
regulation training to regular treatment in a randomized controlled trial.

Adolescence is a critical phase for the development of mental disorders (Lee et
al., 2014); in general, the important developmental period of adolescence is
characterized by large endocrinological and socio-emotional changes that
coincide with more frequent experiences of negative emotions (Spear, 2000;
Zeman, Cassano, Perry-Parrish, & Stegall, 2006). Compared to early childhood,
adolescence comes with increasingly intense and instable emotions and stress
(Dahl, 2001; Ahmed, Bittencourt-Hewitt, & Sebastian, 2015). Therefore,
adolescence is an essential phase in the development of adaptive emotion
regulation skills - increasingly without the aid of parents - and adolescents
are at risk for dysfunctional emotion regulation (Zeman et al., 2006; Ahmed et
al., 2015; Steinberg & Avenevoli, 2000). Emotion regulation refers to *the
processes responsible for monitoring, evaluating, and modifying emotional
reactions, especially their intensive and temporal features, to accomplish
one*s goals* (Thompson, 1994, pp. 27-28). Emotion regulation difficulties
particularly appear to develop at the age of 12-15, and are an important
precursor of subsequent development of mental health problems (Cracco,
Goossens, & Braet, 2017). Research suggests that the characteristics and impact
of emotion regulation differs between adolescent boys and girls (Nolen
Hoeksema, 2012; Stikkelbroek, Bodden, Kleinjan, Reijnders, & van Baar, 2016).

Primary Objective:
- To examine the acceptability and feasibility of an add-on internet-based ERT
training and the trial design in adolescent patients (aged 13-18) with
depressive or anxiety disorders, their parents, and their therapists as
preparation of a future, definitive trial. Therefore, we will:

1. Assess the acceptability and feasibility of the add-on ERT-intervention, in
terms of both quantitative and qualitative evaluation by patients and their
therapists (using questionnaires and focus groups).
2. Assess the preferences of adolescent patients with depressive and anxiety
disorders regarding add-on e-health interventions (using questionnaires and
focus groups).
3. Determine study recruitment, refusal and retention rates (i.e., how many
eligible respondents consent to participate in the study, how many parents
consent with the participation of their child and themselves, what are
follow-up rates of patients and parents at the 3 month and 6 month follow-up
assessments, and what are reasons not to participate with the study or not to
complete one or more assessments?).
4. Determine treatment adherence and drop-out rates (i.e., how many treatment
sessions will participants allocated to ERT complete, and how many participants
will drop-out of treatment?).
5. Examine whether the eligibility criterium regarding age (13-18 years) is too
broad or too narrow in terms of both recruitment rates and acceptability of the
intervention
6. Assess the acceptability and feasibility of the outcome measures as methods
to measure efficacy of the interventions within a future, definitive trial in
both participants and their parents.
7. Assess the feasibility for therapists to guide participants through the
add-on ERT intervention, and to determine which problems they may experience in
the procedures for delivering the intervention (i.e., time-management, giving
feedback on pre-agreed moments, motivate participants)

Secondary Objective:
- To provide a first estimate of the potential effectiveness of CBT + ERT in
reducing emotion regulation difficulties, depressive symptoms, anxiety
symptoms, and internalizing symptoms against CBT alone in adolescent patients
(aged 13-18) with depressive or anxiety disorders, including completion rates,
missing data, estimates, variances and 95% confidence intervals for both
between-group and within-group (i.e., pre-post) differences.

A 2-arm randomized controlled trial with a parallel group design, comparing
effects of CBT + ERT vs. CBT in adolescents with depressive and anxiety
disorders. Follow-up assessments will take place at 3 and 6 months after the
baseline assessment.

Randomization will be carried out after completion of the baseline assessment.
Randomization of participants will be performed by an independent datamanager
of the Arkin Research Department, who is not involved in the research project,
nor involved in providing any kind of mental health care. Randomization will
take place at an individual level, stratified by primary disorder (anxiety
disorder or depression) using a computer-generated block randomization
schedule. To ensure that an equal number of patients will be allocated to CBT
and CBT + ERT, the allocation ratio will be 1:1. To prevent selection bias,
researchers will be blind to block size and order, and will not have access to
the randomization schedule. Due to the nature of treatments, blinding of
participants, parents, and therapists to treatment condition is not applicable.
Since all other measures concern web-based questionnaires that are filled out
by the participants themselves, double data entry procedures are not
applicable.

ERT consists of 6 online sessions of 25 minutes. These will be combined with 2
face-to-face sessions, resulting in a so-called blended treatment. The study
will make use of the online Therapieland platform: a e-mental health platform
for youths that meets all technical demands and guidelines with regard to
privacy and data security, such as EN 7510. The ERT program includes various
(interactive) methods such as videos with psycho-education, exercises, chat
functions, and a library with relevant YouTube videos. Patients will be guided
by a trained clinical or health youth psychologist. After each online session,
these psychologists will provide feedback and guidance using secured email
within the online platform. One face-to-face session will be scheduled at the
start of ERT, in order to make patients acquainted with their psychologist, and
vice versa, and to determine treatment goals. A second face-to-face session
will be scheduled halfway to monitor the patient's progress. Based on the
patient's preference, the 6 sessions of ERT can be completed on a weekly or
biweekly schedule; hence, ERT will be completed in 6 to 12 weeks. The content
of the program is based on existing face-to-face ER interventions for children
and adolescents (Southam-Gerow, 2014). The intervention comprises three core
elements of ER: 1) emotional awareness, 2) emotional comprehension, and 3)
emotion regulation. With emotional awareness, adolescents will learn to
identify emotions in themselves and others, and how emotions can be expressed
in adaptive and maladaptive ways (including facial expressions, body language,
and communication techniques). Additionally, they will learn to focus on their
emotions, and to evaluate their characteristics and intensity. Emotional
comprehension intends to increase the adolescents' knowledge about their own
emotions and the situations that cause them. Also, patients will learn which
helpful and unhelpful behavioral tendencies are triggered by their emotions,
and how they can cope with these tendencies. Emotion regulation focusses on
gaining control of difficult emotions, expressing emotions in helpful ways, and
learning behavioral strategies that help coping with emotions. Patients will
learn various skills to manage and regulate emotions (e.g., by discussing/
writing about them, taking time-outs, relaxation, and movement).

Burden:
Subjects will have to invest time when participating in this study. Subjects in
the experimental condition will need too invest more time than subjects in the
control condition. On the other hand, they will participate in an extra
intervention of which we assume that it improves emotion regulation skills and
reduces anxiety and depression symptoms.
Participants in both conditions will complete questionnaires at baseline, 3
months, and 6 months after randomization.

Risks:
There are no anticipated risks involved in participating in this research.
Patients in both the control and experimental condition receive
treatment-as-usual.