Digital cognitive behavioral therapy for inSomNia symptOms in pRegnant womEn with psychiatric vulnerability: a prospective cohort study

Digital cognitive behavioral therapy for inSomNia symptOms in pRegnant womEn with psychiatric vulnerability: a prospective cohort study - SNORE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55999

Enrollment

Registered

2021-09-06

Start date

2022-02-13

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

difficulty sleeping insomnia

Interventions

CBT-I is a form of evidence-based psychotherapy with a focus on behaviour, thoughts, emotions and their corelation regarding sleep. The digital intervention consists of six modules with explanatory

Eligibility

Inclusion criteria

Inclusion criteria: Being 18 years of age or older Being a pregnant woman in the first trimester up to week 25 of the pregnancy Report sleeping problems with ISI score above cut-off Being able to understand and complete the self-help dCBT-I in Dutch

Exclusion criteria

Exclusion criteria: Patients who have insufficient Dutch language skills Active psychosis drug dependence or abuse Shift- work Use of sleep medication (benzodiazepines) Untreated sleep apnea

Design outcomes

Primary

Measure	Time frame
The main study parameter is the change on Insomnia Severity Index score (ISI) after the intervention.	—

Secondary

Measure	Time frame
- Objective sleep (Actiwatch) - Depression symptoms (HADS) - Anxiety symptoms (HADS) - Sleep medication use	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)