Investigating non-inferiority and additional benefits of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial

Phase 3

Recruiting

• Conditions: DSM-5: insomnia disorder; F51.0; Nonorganic insomnia

• Registration Number: DRKS00028153
• Lead Sponsor: niversitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 422

Inclusion Criteria

1. insomnia disorder according to DSM-5
2. age = 18 years
3. internet access and possession of a computer
4. residence within 1 hour travel distance of a study centre
5. command of the German language
6. informed written consent

Exclusion Criteria

1. any history of additional sleep disorder
2. severe or unstable medical or psychiatric diseases that that require immediate treatment, that have an impact on outcome variables or that may be negatively influenced by sleep restriction
3. imminent suicide risk
4. pregnancy
5. current psychotherapeutic treatment, or presence on a waiting list for such treatment
6. Participation in another clinical trial up to 30 days prior to the start of and during participation in this trial

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI) after intervention (10 weeks after randomization)