StayFine: a personalized monitoring and intervention app to prevent relapse of anxiety and mood disorders in youth and young adults

Anxiety and depressive disorders are the most common mental health disorders
and are associated with large impairment in current and lifelong functioning
and increased suicide risk, even more so in youth. Many youths and young adults
with anxiety or depressive disorders continue to experience new episodes into
adulthood, resulting in high personal and societal costs both in adolescence
and adulthood. As an estimate, 60% of adolescents relapse within three years
after an episode of an anxiety or depressive disorder. If this relapse can be
prevented, the chronic course of these disorders into later adolescence and
adulthood may be broken. However, relapse prevention is hardly studied in
youths internationally, and, to date, there is no intervention available for
adolescents in the Netherlands. It is hypothesized that less youth will relapse
over the course of three years after using a guided app-based modular
intervention (monitoring + intervention) over the course of three years, as
compared to youths that only monitor their symptoms with the app.

To prevent or postpone relapse of anxiety and depression in youth and young
adults, with StayFine; a guided app-based modular intervention. Secondary
objectives are to explore the effect on other relevant outcomes and to study
potential moderators of treatment outcome. Additionally, potential
pretreatment daily affect, fluctuations of affect, and inertia of affect will
be explored and the acceptability of the intervention including monitoring will
be established.

A randomized controlled trial comparing the guided app-based modular StayFine
intervention (monitoring + intervention) to monitoring only.

The guided app-based modular StayFine intervention consists of eight modules,
of which three are mandatory and three others are assigned based on a
personalization procedure. The intervention is based on the well-established
Preventive Cognitive Therapy (PCT) for relapse prevention for adults and
adapted and supplemented for anxiety in adolescents. The PCT modules consist of
psycho education, cognitive restructuring, positive affect and a relapse
prevention plan. The following modules were added to PCT; behavioral
activation, exposure, wellness and sleep. An app-buddy can be included to
provide support. In both conditions adolescents monitor their symptoms five
times in three years and feedback and treatment advice is given in case of
relapse. In the control condition only monitoring takes place.

There are minimal risks associated with this trial, the only conceivable but
negligible risk is violation of privacy as patient data are transmitted over
the internet. However, the assessments will be made as secure as possible and
meet the quality criteria of the Dutch norm NEN7510.
There is some degree of burden because monitoring at baseline and follow up
takes up some time. Participants will receive reminders through email or the
app to adhere to the monitoring. Also the participants that choose to use the
wearable, will wear the wearable that looks like a watch. We expect this to be
a small burden, especially if participants also wear a watch on the other arm;
however the other study procedures are low-threshold because they can be done
via the participant's phone or computer. Also, the expected therapeutic effect,
to prevent relapse, is considered as a possible benefit for the participant in
both the monitoring and intervention condition. Therefore, we think the small
burden and minimal risk are justified in this study.