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 severe mental illness

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 severe mental illness - Early intervention in people at risk for severe mental illness

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53231

Enrollment

Registered

2023-09-21

Start date

2024-08-20

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mood swings prodromal symptoms of SMI

Interventions

In this protocol, a personalized early intervention program (lifestyle psycho-education and ImCT

lifestyle psycho-education and ImCT + bright light therapy

lifestyle psycho-education and ImCT + blue-light blocking glasses) will be assessed. During the course of the study, all patients keep receiving their regular consultation with their healthcare prof

Eligibility

Age

16 Years to 64 Years

Inclusion criteria

Inclusion criteria: Must be bound to start the early intervention program being evaluated Aged 16-35, or > 35 by indication of the patients* treating clinician 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

Exclusion criteria: Any current or previous neurological disorder or organic brain disease. IQ < 70 estimated by clinician. Current severe substance or alcohol misuse impacting treatment (clinicians assessment).

Design outcomes

Primary

Measure	Time frame
Changes in the level of mood and anxiety symptoms, as well as circadian rhythm and activity levels measured at multiple time points, will give insight into potential effectivity and support the importance of future randomized controlled trials (RCT). Also, experience sample monitoring (ESM), adverse (side) effects, drop-out rates and qualitative review of therapy will provide feasibility and acceptability outcomes.	—

Measure

Time frame

Changes in the level of mood and anxiety symptoms, as well as circadian rhythm and activity levels measured at multiple time points, will give insight into potential effectivity and support the importance of future randomized controlled trials (RCT). Also, experience sample monitoring (ESM), adverse (side) effects, drop-out rates and qualitative review of therapy will provide feasibility and acceptability outcomes.

—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)