Psychiatric assessment Revisited: Social, Psychophysiological and Environmental Characterization of a Transdiagnostic cohort (PRoSPECTs) feasibility study

Unlike most branches of medicine, psychiatric diagnoses are based on
characteristic clusters of mostly subjectively experienced signs and symptoms
that are not necessarily connected to a specific etiology and / or
pathophysiology. Relatedly, most diagnostic classifications limitedly predict
treatment response and outcome. Given the enormous burden associated with
mental disorders and overall modest effects of treatment, other ways to improve
treatment outcome are needed. We propose to take a *pragmatic*, yet
evidence-based approach to improve clinical decision making, by developing and
applying precision medicine. Adhering to new and relevant insights into the
developmental, dimensional, dynamic and complex nature of mental disorders, we
propose that the inclusion of markers of underlying biological, psychological
and social processes, as well as clinical and treatment characteristics are
important to improve tailored treatment and prediction of outcomes. In order to
maximize the (ecological) validity of the assessments, methodological
innovation to address individual change and context is needed. Finally, given
that many diagnostic categories share substantial overlap in symptom
presentation, pathophysiology, risk factors and response to treatment,
transdiagnostic prognostic assessments are needed to uncover new and relevant
subgroups. In order to examine whether a novel, transdiagnostic standardized
assessment of the above-mentioned domains is helpful to identify clinically
relevant subgroups and develop a framework for precision psychiatry in academic
mental healthcare, a developmental research approach needs to be taken. This
means starting out with feasibility studies for the assessments, then starting
up a clinical cohort study to link these pre-treatment factors to treatment
outcomes and develop and validate prognostic models based within the mental
health care setting. Finally, these models, if promising, can be transformed
into easy-to-use decision tools, which will be evaluated and compared against
regular diagnostic classifications to determine whether clinical utility can be
increased. We aim to pursue all these steps with the Psychiatric assessment
Revisited: Social, Psychophysiological and Environmental Characterization of a
Transdiagnostic cohort (PRoSPECTs) study, within the University Center of
Psychiatry (UCP).

The objective of the current study is to assess feasibility and acceptance of
the pre-treatment assessments (PRoSPECTs feasibility study).

This study consists of two subsequent phases, in which a heterogeneous patient
group of the UCP will be administered the pre-treatment assessments. Phase 1,
which is mainly focused on acceptance of patients, entails qualitative
interviews with patients about the assessment. Phase 2, entails, next to
qualitative assessments of acceptance, quantitative assessments of feasibility.

The health risks attached to participation will be negligible. In terms of
risk, venipuncture, which is part of the assessments, is associated with
negligible and known risks (e.g. skin irritation and bruising), with negligible
to mild burden. Other assessments, such as a short physical assessment, can
make participants feel uncomfortable. This constitutes a negligible to mild
burden. The assessments cost time. Patients will be assessed and interviewed at
baseline and two weeks thereafter, with a total assessment time at the UCP of
about 3 hours. In addition, patients will fill out questionnaires at home,
which takes about 30 minutes. Finally, during two weeks, patients will fill out
several questions on their smartphone five times a day (3 minutes per
assessment) and wear an actigraphy device around their wrist. Benefits might
include an increased insight in their own momentary affect patterns as personal
feedback on the daily life assessments is part of the study. As severe mental
health problems may interfere with decision-making, concentration, attention
and energy, we will take this into account by taking at least 20 minutes to
welcome the participants with a beverage and provide answers to any of their
questions or concerns about the study. In addition, more cognitively demanding
tasks will be alternated with more easy ones, and brief breaks will be
inserted. Participants can object to any or part of the assessments during
study participation.