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

NCT ID: NCT06282250

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2025-12-31

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.

Detailed 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."

Conditions

Bipolar Disorder; Mood Swing; Prodromal Symptoms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Psycho-education and Imagery Focused Cognitive Therapy (in addition to Bright Light Therapy)

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.

Group Type: OTHER

Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Week 1: Psycho Education, 1 session.

Week 2-7: ImCT will follow, 6 sessions.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Psycho-education + Imagery focused Cognitive Therapy

Week 1: Psycho Education, 1 session.

Week 2-7: ImCT will follow, 6 sessions.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geestelijke Gezondheidszorg Eindhoven (GGzE)

OTHER

Sponsor Role: lead

Responsible Party

Else Treffers

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inge Bongers, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

GGzE, Tilburg University

Locations

Geestelijke Gezondheidszorg Eindhoven (GGzE)

Eindhoven, North Brabant, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Else Treffers, MSc

Role: CONTACT

else.treffers@ggze.nl

+31622559192

Liselore Snaphaan, PhD

Role: CONTACT

liselore.snaphaan@ggze.nl

Facility Contacts

Else Treffers, MSc

Role: primary

else.treffers@ggze.nl

+31622559192

Other Identifiers

in progress

Identifier Type: -

Identifier Source: org_study_id