protocolSection identificationModule nctId: NCT06282250, orgStudyIdInfo id: in progress, briefTitle: Seeing the Light: Early Intervention in People at Risk for Bipolar Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Geestelijke Gezondheidszorg Eindhoven (GGzE), class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Bipolar Disorder, conditions: Mood Swing, conditions: Prodromal Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy, interventions name: Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy, interventions name: Psycho-education + Imagery focused Cognitive Therapy, outcomesModule primaryOutcomes measure: Change in depressive symptom scores on the IDS-SR, primaryOutcomes measure: Change in hyperactive symptom scores on the ASRM, primaryOutcomes measure: Change in anxiety symptom scores on the BAI, primaryOutcomes measure: Change in sleep quality subjective rating on 11-point Likert scale, primaryOutcomes measure: Change in activity levels subjective rating on 11-point Likert scale, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Geestelijke Gezondheidszorg Eindhoven (GGzE), status: RECRUITING, city: Eindhoven, state: Noord-Brabant, zip: 5626ND, country: Netherlands, contacts name: Else Treffers, MSc, role: CONTACT, phone: +31622559192, email: else.treffers@ggze.nl, geoPoint lat: 51.44083, lon: 5.47778, hasResults: False