A real-time and real-world intervention focusing on stress and reward

Despite attempts to prevent or delay transition to chronic psychosis with
antipsychotic medication or traditional cognitive behavioural therapy (CBT),
individuals with an at-risk mental state (ARMS) or a first episode psychosis
(FEP) present with poor functioning and high levels of general psychopathology,
even in the absence of transition. Acceptance and commitment therapy (ACT; a
next generation CBT) is aimed at changing the relationship between the
individual and his complaints through detachment and acceptance. Clinical
improvement is achieved as a result of reduced distress and impairment, rather
than the other way around. As such, ACT could be a particularly interesting
candidate treatment for this vulnerable group. A promising new intervention
method includes integration of the treatment in the daily-lives of the
individuals using mobile technology, which could substantially increase the
treatment effects.

The current project aims to investigate the efficacy of a new form of treatment
that integrates ACT in the daily-lives of ARMS individuals using a small
digital device (PsyMate®). We hypothesise the ARMS and FEP individuals who
receive the experimental treatment to improve on measures of clinical and
general functioning, stress-reactivity, and reward-experience compared to
individuals who receive a control treatment.

A multi-centre randomised controlled trial (RCT) with three arms i) daily-life
ACT and treatment as usual, ii) cognitive behavioral therapy as usual, and iii)
treatment as usual, with measurements at pre-intervention, post-intervention,
and follow-up at six, 12, and 24 months post-intervention.

Participants in the daily-life ACT group will receive one psychoeducation
session and seven ACT sessions, embedded in a nine-week period during which
they are trained to apply the skills learned during the sessions to their daily
lives with help of a PsyMate®. Participants. All groups will receive TAU from
the clinic or institution they are admitted to.

There are no health-risks associated with participation. The total time
investment for participation during the intervention period depends on group
relatedness.

There will be five moments of assessment of our main study parameters each
using interviews and questionnaires and six-day ESM periods. These measurements
will be equal for all groups and require a time investment of approximately 28
hours in total, divided over a period of two years. Given that all participants
are expected to benefit from participation, the burden should be considered
acceptable.

Those participants who were randomised in the Daily-life ACT group receive an
additional 8 therapeutic sessions of 45 minutes to 1 hour and are expected to
practice ACT exercises daily under the guidance of the PsyMate.