Better nights, better days? The role of sleep in (dis)stress, anxiety and emotion regulatio

Recruiting

Conditions: insomnie
insomnia
sleep problems
10037173

Registration Number: NL-OMON52321

Lead Sponsor: GGZ Buitenamstel (Amsterdam)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 576

Inclusion Criteria

18 years or older
Insomnia Severity Index score >=10
Self-considered capability of completing online questionnaires and diaries in
Dutch.
Clinically relevant mental health complaints according to the Rapid Measurement
Toolkit 20-item (RMT-20) questionnaire cut-offs in at least one of its
dimensions of PTSD (>=8), Social Anxiety Disorder (>=12), Panic disorder (>=9) or
Generalized Anxiety Disorder (>=11), or according to the Ultrashort BPD
Checklist (BPD-C) indicated by a score >=14. Patients recruited through GGZ are
required to be diagnosed with an anxiety disorder according to the MINI or BPD
diagnosis (or other personality disorder with at least 4 BPD traits of which at
least one of the following traits: *affective instability*, *impulsivity*,
*parasuicidal behavior*, *anger attacks*, according to the SCID-5-P.

Exclusion Criteria

The main exclusion criteria are based on the probable inability to comply with
ICBTI instructions and the assessments, as we expect to occur in people
currently diagnosed with bipolar disorder, psychotic disorder, and alcohol or
substance dependency. Potential participants that underwent CBT-I treatment in
the last 3 months will be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of the RCT is the insomnia severity. Insomnia Severity is<br /><br>measured with the Insomnia Severity Index (ISI). For the study with subjects<br /><br>with borderline personality disorder, the amount of BPD symptoms is the primary<br /><br>outcome measure, this is measured with the Borderline Personality Disorder<br /><br>Severity Index (BPDSI).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes address three domains: sleep, mental health, and daytime<br /><br>functioning and well-being. They include I) other indicators of sleep and<br /><br>overnight alleviation of distress assessed from a sleep diary kept online for a<br /><br>week and from headband EEG assessed at home for four nights within that week<br /><br>(unless participant decides not to take part in the EEG assessments); II) the<br /><br>severity of mental health complaints characterizing different diagnostic<br /><br>dimensions, as well as well-being and daytime functioning including health<br /><br>behaviors and use of care, all assessed by online surveys at T0, T1 (2 months)<br /><br>and T2 (8 months). For the study with subjects with borderline personality<br /><br>disorder an additional clinical interview is done at T0, T1 (2 months) and T2<br /><br>(8 months). Qualitative assessment of experiences with the intervention in a<br /><br>sub-sample of participants (process evaluation interviews) </p><br>