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

Recruiting

Conditions: Insomnia disorder in combination with (symptoms of) anxiety (GAD, SAD, PD, PTSD) or borderline personality disorder.

Registration Number: NL-OMON21458

Lead Sponsor: Stichting Vrije Universiteit Medisch Centrum, Afdeling Psychiatrie

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.
? For patients recruited through SGGZ at GGZ Ingeest: meeting the criteria for an anxiety
disorder according to the M.I.N.I. International Neuropsychiatric Interview or the criteria
for borderline personality disorder according to the SCID-5-P structured clinical interview
for DSM-5 personality disorders (section BPD).
? 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 (BPDC)
indicated by a score =14.

Exclusion Criteria

The main exclusion criteria are based on the probable inability to comply with i-Sleep instructions and the assessments, as we expect to occur in people currently diagnosed with bipolar disorder or psychotic disorder (single question), or misusing alcohol or drugs (scores of = 12 on the AUDIT (Saunders et al., 1993) and DUDIT (Kraanen, 2008 ) questionnaires). We aim to include both males and females. Additionally, people that have undergone CBT treatment for insomnia in the past three months will be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome of the RCT is insomnia severity, as measured with the Insomnia Severity Index (ISI). For the study with subject with borderline personality disorder (BPD), the amount of BPD symptoms is the primary outcome measure, this is measured with the Borderline Personality Disorder Severity Index (BPDSI).

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes address three domains: sleep, mental health, and daytime functioning and well-being. They include I) other indicators of sleep and overnight alleviation of distress assessed from a sleep diary kept online for a week and from headband EEG assessed at home for four nights within that week (unless participants decide not to take part in the EEG assessments); II) the severity of mental health complaints characterizing different diagnostic dimensions, as well as well-being and daytime functioning including health behaviours and use of care, all assessed by online survey or clinical interview at T0, T1 (2 months) and T2 (8 months). For the study with subjects with BPD, insomnia severity, as measured with the ISI is an additional secondary outcome.