Seeing the Light: Early Intervention in People at Risk for Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282250
• Other study ID #: in progress
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Geestelijke Gezondheidszorg Eindhoven (GGzE)
• Contact: Else Treffers, MSc
• Phone: +31622559192
• Email: else.treffers[@]ggze.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Severe mental illnesses (SMI) distinguished as bipolar disorder and psychotic spectrum disorders, substantially impair patients' engagement in functional and occupational activities and severely limit social and societal functioning (GGZ Standaarden, 2022; NIH, 2022; NIMH, 2018). Based on the Dutch definition of SMI 1.7% of the national population suffers from an SMI (GGZ Standaarden, 2022). Despite this, time between first symptoms and accurate SMI diagnosis, can add up to more than 9.5 years in the case of bipolar disorders. For the psychotic spectrum, an early detection and intervention program (UHR) carried out by special EDI-Teams already exists, and has been found effective in limiting the transition to SMI with fifty percent. For bipolar disorders, no such program exists. This raises the question whether prodromal and subclinical symptoms of this disorder can be detected earlier and if transition into SMI can be limited. In light of current studies into the at-risk mental state, and the current development towards a possible transdiagnostic model for early detection and intervention of SMI (CHARMS-categories; (Liu et al., 2022)), the current study aims to contribute to limiting the transition into bipolar disorder. As a disturbance in circadian rhythm, as well as mood and anxiety symptoms are risk indicators for SMI in general and bipolar in specific, the current study evaluates an early intervention program for individuals at risk for developing an SMI, with a focus on bipolar symptomatology.

Individuals at risk will answer questions from the SIBARS interview. As explained in a publication of Fusar-Poli et al. (2022), "The Semi-structured Interview for Bipolar At Risk States (SIBARS) included a combination of several items adapted from well-established rating scales: (CAARMS (Yung et al., 2005); Hypomania Checklist-32 (Angst et al., 2005); Altman Self-Rating Mania Scale (Altman et al., 1997); TEMPS-A questionnaire (Akiskal et al., 2005); QIDS-SR (Rush et al., 2003); Bergen Insomnia Scale (Pallesen et al., 2008); Idiopathic hypersomnia questionnaire (Vernet et al., 2010)). The SIBARS interview was developed for youths aged 15-35 and comprehended 5 domains: 1. Subtreshold Mania, 2. Depression, 3. Cyclothymic Features, 4. Genetic Risk, 5. Mood Swings. Subtreshold Mania, Depression and Mood Swings are continuous rating scales (that include a severity and frequency anchors), while Cyclothyimc Features and Genetic Risk are categorical scales (yes/no). The cut-offs allow assigning the specific subgroup of the BARS criteria: 1. Substreshold Mania, 2. Depression+Cyclothymic Features, 3. Depression+Genetic Risk, 4. Cyclothymic Features+Genetic Risk, 5.Subtreshold Mixed Episode, 6. Mood Swings."

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Mood Swing
• Prodromal Symptoms

Intervention

Behavioral:
• Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy
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.
• Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy
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.
• Psycho-education + Imagery focused Cognitive Therapy
Week 1: Psycho Education, 1 session. Week 2-7: ImCT will follow, 6 sessions.

Locations

Country	Name	City	State
Netherlands	Geestelijke Gezondheidszorg Eindhoven (GGzE)	Eindhoven	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Geestelijke Gezondheidszorg Eindhoven (GGzE)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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