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

• Conditions: mood swings; prodromal symptoms of SMI; 10037176

• Registration Number: NL-OMON53231
• Lead Sponsor: GGZ Eindhoven (Eindhoven)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>