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 Bipolar Disorder

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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. Additionally, in a separate validation study, data will be collected to validate a new instrument for the early detection of those at risk for bipolar disorders. The Semistructured Interview of At Risk Bipolar States (SIBARS) (Fusar-Poli et al., 2022) will be translated and validated in a Dutch sample, in cooperation with its creators, Prof. Dr. P. Fusar-Poli and colleagues.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 35
Healthy Volunteers: f
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• Must be bound to start the early intervention treatment being evaluated

• Aged 16-35, or \> 35 by indication of the patients' treating clinician

• Found to be at risk for SMI, as determined by the Early Detection and Intervention Team of GGzE

• Sufficient knowledge of Dutch or English language

• Ability to give informed consent

• Willing to complete daily monitoring throughout the duration of the study

Locations
Other Locations
Netherlands
Geestelijke Gezondheidszorg Eindhoven (GGzE)
RECRUITING
Eindhoven
Contact Information
Primary
Else Treffers, MSc
else.treffers@ggze.nl
+31622559192
Backup
Liselore Snaphaan, PhD
liselore.snaphaan@ggze.nl
Time Frame
Start Date: 2024-05
Estimated Completion Date: 2025-12
Participants
Target number of participants: 50
Treatments
Other: Psycho-education and Imagery Focused Cognitive Therapy (in addition to Bright Light Therapy)
Treatment will be personalized in accordance to one of three options:~1\. In case of depressive symptoms.~Bright Light Therapy (BLT) will be administered for 30 minutes on five consecutive days (duration: 1-3 weeks).~1 PE session focused on lifestyle and physical activity will take place. 6 sessions of ImCT will take place. This includes in-depth identification of images, constructing a micro-formulation along the lines of regular Cognitive Behavioural Therapy.~2\. In case of hyperactivity symptoms.~The same PE and ImCT will be administered. The exception is that in this case, BLT is replaced by wearing blue-light blocking glasses for 1-3 weeks, 1 hour prior to bedtime.~3\. In case of at risk mental state, but no clear depressive or hyperactive symptoms.~The same PE and ImCT will be administered. There will be no light intervention.
Related Therapeutic Areas
Sponsors
Leads: Geestelijke Gezondheidszorg Eindhoven (GGzE)

This content was sourced from clinicaltrials.gov