insomnie insomnia sleep problems
Conditions
Interventions
ICBTI is a guided, internet-based cognitive behavioural therapy program for
insomnia, and consists of five online sessions:
1. Psycho-education
2. Sleep restriction
3. Rumination and relaxation te
Sponsors
GGZ Buitenamstel (Amsterdam)
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the RCT is the insomnia severity. Insomnia Severity is measured with the Insomnia Severity Index (ISI). For the study with subjects with borderline personality disorder, the amount of BPD symptoms is the primary outcome measure, this is measured with the Borderline Personality Disorder Severity Index (BPDSI). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 participant decides 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 behaviors and use of care, all assessed by online surveys at T0, T1 (2 months) and T2 (8 months). For the study with subjects with borderline personality disorder an additional clinical interview is done at T0, T1 (2 months) and T2 (8 months). Qualitative assessment of experiences with the intervention in a sub-sample of participants (process evaluation interviews) | — |
Countries
Netherlands
Outcome results
None listed