Investigating the effects of digital cognitive behavioral psychotherapy of insomnia (dCBT-I) on sleep in insomnia

Not Applicable

• Conditions: F51.0; G47.0; Nonorganic insomnia; Disorders of initiating and maintaining sleep [insomnias]

• Registration Number: DRKS00030897
• Lead Sponsor: Heinrich-Heine-Universität Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Study Completion: 2023-07-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Confident use of the smartphone/tablet/computer
- Stable Internet access

Exclusion Criteria

- Bipolar disorder
- Epilepsy
- Pregnancy
- Shift work
- Presence of another sleep disorder (diagnostic interview)
- Parallel psychotherapy for the treatment of sleep disorders
- Regular drug and alcohol use (> 3 glasses of alcohol per day, more than 21 days), marijuana use (> 1x per week; self-report)
- Acute suicidality (suicide item > 1 in the Beck Depression Inventory BDI & suicidality according to questioning in a telephone interview)
- Psychosis

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia severity, post-treatment (8 & 16 weeks post-randomization) as measured with the Insomnia Severity Index (ISI)

Secondary Outcome Measures

Name	Time	Method
- Sleep continuity (as measured with a sleep diary and actigraphy; continuously for 8 weeks during the intervention)<br>- Dysfunctional beliefs about sleep (DBAS; 8 & 16 weeks post-randomization)<br>- Pre-Sleep Arousal (PSAS; 8 & 16 weeks post-randomization)<br>- Daytime well-being (WHO-5; 8 & 16 weeks post-randomization)<br>- Quality of life (WHQOL_BREF; 8 & 16 weeks post-randomization)<br>- Symptoms of anxiety and depression (HADS; 8 & 16 weeks post-randomization)