Seeing the Light: Early Intervention in People at Risk for Bipolar Disorder
A legfontosabb adatok
- Ki végzi
- Geestelijke Gezondheidszorg Eindhoven (GGzE)
- Hol
- Hollandia1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 50 fő, tervezett
- Kezdés
- 2024. aug. 20.
- Várható befejezés
- 2027. nov. 9.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy
- Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy
- Psycho-education + Imagery focused Cognitive Therapy
- A regiszteradat frissítve
- 2026. november 12.
Ki vehet részt
- Életkor
- 16 év – 35 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 10 feltétel megnézéseKevesebb
Ki vehet részt
- Must be bound to start the early intervention treatment being evaluated at GGzE
- 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
Ki nem vehet részt
- Previously received BLT (less than 3 weeks prior to study entry
- Learningdifficulties,organicbraindiseaseorsevereneurologicalimpairment
- Current severe substance or alcohol misuse (clinicians' assessment)
- In case of BLT: eye problems contraindicating BLT and/or being unable to visit the GGzE
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 16 és 35 év között vagy?
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
This intervention study is part of a larger research project in The Netherlands, GGzE Eindhoven. Researchers have started mapping the current use of psychological therapy, bright light therapy and lifestyle interventions in individuals presenting with mood symptoms that might be risk factors for future development of Bipolar Disorders. Based on the outcomes of this scoping review, a unique intervention program as described above will be formed.
A vizsgálat csoportja
- Psycho-education and Imagery Focused Cognitive Therapy (in addition to Bright Light Therapy)Egyéb csoport
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.
Kezelés: Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy, Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy és Psycho-education + Imagery focused Cognitive Therapy
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- 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
- Illeszkedési kérdések
- Forrás: NCT06282250: ki vehet részt
- Publikációk
- A regiszteradat frissítve
- 2026. november 12.