A study on the effectiveness and efficiency of the NiceDay Smartphone Application in psychiatric patients with unipolar depression

*Behavioral activation is an evidence-based effective treatment for unipolar
depression. The patient is motivated to reach daily goals such as eat- sleep
and social rhythms, adequate amounts of physical exercize, outdoor activities
and emotional awareness. The effect of behavioral activation is comparable to
that of Cognitive Bahavioral therapy (CBT), which is still the psychotherapy of
preference for the treatment of unipolar depression. Behavioral activation,
however, is much easier to perform and less costly than CBT.

Until now, patients were motivated to reach their activation goals by medical
personell within an office building, or even behind a desk. NiceDay is a
Smartphone application that allows for the automization and intensification of
behavioral activation. By using mobile communication technology, it is possible
to relay the effects of behavioral activation directly to the patiënt, at the
precise time and location that is most relevant to the problem at hand (this is
called *direct feedback*). Direct feedback shortens the delay between the
expression of certain (healthy) behavior and the (positive) reinforcement of
that behavior. This reduces stimulus contingency and clarifies the
relationships between certain types of behavior and the consequences of that
behavior. Because of this, we expect NiceDay activation to show a greater
efficiency and efficacy than behavioral activation as usual.

NiceDay is unique in the sense that it uses the > 30 sensors that are part of
every Smartphone to determine to what extent the user has reached his or her
goals. This reduces the necessity of user input to a great extent, which makes
NiceDay very user friendly. In that sense, NiceDay can be called the "Holter
ECG of psychiatry", which attempts to identify problems of a patient's daily
rhythm. Additionally, NiceDay is much like a pacemaker that corrects daily
rhythms as soon as they appear to run out of control. NiceDay is therefore both
a diagnostic and a therapeutic agent that enables patients to go anywhere they
want and still carry their own professional coach with them.

To examine whether indeed behavioral activation using the NiceDay smartphone
app is more efficient and more effective in treating patients with unipolar
depression than treatment as usual (TAU).

A prospective cohortstudy with a randomised, controlled (TAU) involving a 4
months' activation period (NiceDay activation <=> TAU) and a follow-up period
of 8 months (the total daration of this study is therefore 1 year). Considering
the nature of the intervention (Smartphone App) and the control condition
(TAU), this study cannot be carried out in a (double)blinded fashion. This
study will be conducted at various settings within PsyQ and does not involve a
multicenter trial.

NiceDay behavioral activation versus behavioral activation as usual, cross
over.

Apart from behavioral activation, patients receive standard treatment for
unipolar depression. This consists of a combination of pharmacotherapie
(provided by a psychiatrist) plus cognitive behavioral therapy (CBT) (provided
by a psychologist with adequate CBT training).

Within the total timespan of this study (1 year), patients are asked to spend a
total of 12-18 hours of time performing study-related procedures. The total
number of visits to the outpatient clinic will be the same as that of treatment
as usual (once every 2 weeks) up to a maximum of 12 visits, including
follow-up. Patients are required to fill out a questionaire of 30 minutes at
each visit. Risks for enrolled patiënts are considered minimal. The use of the
Smartphone app is expected to convey minimal risk. No biomaterials will be
sampled in these patients. There will be no physical examination. Chances of
physical, physiological or psychological injury are considered minimal.