Seeing the Light: Early Intervention in People at Risk for 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
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2023
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 11, 2024
April 1, 2024
1.1 years
July 3, 2023
April 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change in depressive symptom scores on the IDS-SR
Significant lowering of IDS-SR questionnaire scores
at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Change in hyperactive symptom scores on the ASRM
Significant lowering of ASRM questionnaire scores
at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Change in anxiety symptom scores on the BAI
Significant lowering of BAI questionnaire scores
at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Change in sleep quality subjective rating on 11-point Likert scale
Significant improvement in subjective rating of sleep quality questionnaires
at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Change in activity levels subjective rating on 11-point Likert scale
Changes in daily and pre-post intervention self-report measurement of activity levels
at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Study Arms (1)
Psycho-education and Imagery Focused Cognitive Therapy (in addition to Bright Light Therapy)
OTHERTreatment 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.
Interventions
Week 1-3: BLT will be administered for 30 minutes on five consecutive days, starting on Monday of the work week, between 7:30 AM and 10:00. The effect of the light therapy is evaluated by means of the Self-Rated Quick Inventory of Depressive Symptoms (QIDS-SR). Further treatment strategy is determined on the basis of these results: * If the patient has achieved remission (QIDS-SR \< 6), BLT has been successful and the patient can continue with PE and IMCT. * If there is insufficient or no response (QIDS-SR of 6 or higher), BLT is extended with five more sessions the following week. * If necessary, a third week is optional. Week 2-4: Psycho Education will follow, 1 session. Week 3/4-9/10: ImCT will follow, 6 sessions.
Week 1-3: blue-light blocking glasses will be administered. Week 2-4: Psycho Education will follow, 1 session. Week 3/4-9/10: ImCT will follow, 6 sessions.
Week 1: Psycho Education, 1 session. Week 2-7: ImCT will follow, 6 sessions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Geestelijke Gezondheidszorg Eindhoven (GGzE)
Eindhoven, North Brabant, 5626ND, Netherlands
Related Publications (1)
Treffers E, Snaphaan L, van den Berg KC, Bongers IMB. A study protocol for the feasibility and acceptability of a personalized early intervention combining light therapy, lifestyle psychoeducation, and imagery-focused cognitive therapy in individuals at risk for bipolar disorder. Int J Bipolar Disord. 2026 Jan 22. doi: 10.1186/s40345-026-00410-4. Online ahead of print.
PMID: 41572055DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inge Bongers, Prof. Dr.
GGzE, Tilburg University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 3, 2023
First Posted
February 28, 2024
Study Start
May 1, 2024
Primary Completion
June 1, 2025
Study Completion
December 1, 2025
Last Updated
April 11, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After pilot, June 2025, protocol will be expanded to multi-centre level.
The raw data is generated at the research location and is not shared with other researchers working elsewhere. After publication of the results, only data without privacy sensitive information and without study specific codes (fully anonymous), that support the findings are available from GGzE upon reasonable request (both in and outside the European Union). Before sharing this anonymous data, GGzE carefully investigates this request in consideration of the Dutch AVG and UAVG (Dutch Act on Implementation of the General Data Protection Regulation).