An explorative and experimental study to assess the feasibility, acceptability, and effectiveness of early intervention with light, lifestyle and ImCT therapy in individuals at risk for severe mental illness

Severe mental illnesses (SMI) distinguished as bipolar disorder and psychotic
spectrum disorders, substantially impair patients' engagement in functional and
occupational activities and severely limit social and societal functioning (GGZ
Standaarden, 2022; NIH, 2022; NIMH, 2018). Based on the Dutch definition of SMI
1.7% of the national population suffers from an SMI (GGZ Standaarden, 2022).
Despite this, time between first symptoms and accurate SMI diagnosis, can add
up to more than 9.5 years in the case of bipolar disorders. For the psychotic
spectrum, an early detection and intervention program (UHR) carried out by
special EDI-Teams already exists, and has been found effective in limiting the
transition to SMI with fifty percent. For bipolar disorders, no such program
exists. This raises the question whether prodromal and subclinical symptoms of
this disorder can be detected earlier and if transition into SMI can be
limited. In light of current studies into the at-risk mental state, and the
current development towards a possible transdiagnostic model for early
detection and intervention of SMI (CHARMS-categories; (Liu et al., 2022)), the
current study aims to contribute to limiting the transition into bipolar
disorder. As a disturbance in circadian rhythm, as well as mood and anxiety
symptoms are risk indicators for SMI in general and bipolar in specific, the
current study evaluates an early intervention program for individuals at risk
for developing an SMI, with a focus on bipolar symptomatology.

In the current study, the feasibility, acceptability and effectivity of a new
add-on early intervention program for individuals at risk for the development
of bipolar disorder is evaluated. This intervention program entails
psycho-education, light and lifestyle therapy in combination with Imagery
focused Cognitive Therapy (ImCT). The program aims to contribute to early
intervention by focusing on subclinical mood swings, anxiety symptoms,
circadian rhythm and lifestyle factors such as activity level. We hypothesize a
relationship between this early intervention and a significant improvement in
mood symptoms, anxiety, subjective and objective sleep factors and lifestyle
variables. Also, the feasibility, acceptability and associations with clinical
improvement of symptoms will be studied.

The present research proposal concerns an experimental design with staggered
baseline, and follow-up. Also, we aim to explore the working mechanisms of
early intervention in this form by daily measurements of symptoms.

In this protocol, a personalized early intervention program (lifestyle
psycho-education and ImCT; lifestyle psycho-education and ImCT + bright light
therapy; lifestyle psycho-education and ImCT + blue-light blocking glasses)
will be assessed. During the course of the study, all patients keep receiving
their regular consultation with their healthcare professional (to advise,
monitor, and if necessary, adjust medication and treatment plan). All
intervention elements are currently care as ususal (CAU) in patients with a
bipolar disorder diagnosis and will now be studied in a population at risk for
this diagnosis.

Risks for patients in this study are minimal, since all intervention elements
are supported by evidence-based guidelines and are CAU within GGzE. Similar
interventions have been successfully tested and applied in feasibility trials
for patients groups with a diversity of diagnoses. The results of these studies
suggest that these interventions are well tolerated and received. Additionally,
studies have shown that regular mood monitoring can be a contributing factor to
mood stability (Miklowitz et al., 2012; van der Watt et al., 2020). All
patients, being individuals at risk for SMI, have regular appointments with
their healthcare professional to monitor medication use, mental and daily
functioning. Also, people at risk for SMI with suicidal related thoughts are
not more likely to act on these thoughts while participating in this study
since the urge to act on suicidal thought does not increase after talking about
these thoughts. Since people at risk for SMI might not yet have a diagnosis and
treatment plan, the intervention offered might burden them in terms of
commitment and travel time. However, expectation is that patients found to be
at risk for SMI will already be following treatment or will be on the waiting
list for treatment. The extra burden for patients at risk for SMI is the daily
self-monitoring (ESM), that require them to complete a questionnaire (5-10 min)
at three at equidistant time points, as well as carrying a movement monitoring
device for multiple days and completing questionnaires at baseline, end of
treatment and follow-up (30 minutes). Finally, patients will be asked to
participate in one extra appointment at the end of the treatment program, for a
single qualitative review about the intervention.