Early intervention program for individuals at risk of bipolar disorder
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
This study is testing a new early intervention program that combines education, light therapy, and therapy techniques to help people at risk of bipolar disorder improve their mood, anxiety, and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 16 Years to 35 Years |
| Sex | All |
| Sponsor | Geestelijke Gezondheidszorg Eindhoven (GGzE) Academic / other |
| Locations | 1 site (Eindhoven, Noord-Brabant) |
| Trial ID | NCT06282250 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility, acceptability, and effectiveness of a new early intervention program for individuals at risk of developing bipolar disorder. The program combines psycho-education, light therapy, and Imagery focused Cognitive Therapy (ImCT) to address subclinical mood swings, anxiety symptoms, and lifestyle factors. The aim is to improve mood symptoms, anxiety, sleep quality, and overall lifestyle variables while also validating a new instrument for early detection of at-risk individuals. The study seeks to limit the transition to severe mental illness by providing timely interventions.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16-35 who are at risk for severe mental illness and can provide informed consent.
Not a fit: Patients with learning difficulties, severe neurological impairments, or those who have recently received light therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the risk of developing bipolar disorder in at-risk individuals.
How similar studies have performed: Other studies have shown success with early intervention programs for psychotic spectrum disorders, suggesting potential for similar outcomes in bipolar disorder.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Learningdifficulties,organicbraindiseaseorsevereneurologicalimpairment. * Previously received BLT (less than 3 weeks prior to study entry * Current severe substance or alcohol misuse (clinicians' assessment) * In case of BLT: eye problems contraindicating BLT and/or being unable to visit the GGzE
Where this trial is running
Eindhoven, Noord-Brabant
- Geestelijke Gezondheidszorg Eindhoven (GGzE) — Eindhoven, Noord-Brabant, Netherlands (Recruiting)
Study contacts
- Principal investigator: Inge Bongers, Prof. Dr. — GGzE, Tilburg University
- Study coordinator: Else Treffers, MSc
- Email: else.treffers@ggze.nl
- Phone: +31622559192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.