Effects of digital cognitive-behavioral psychotherapy for insomnia (dCBT-I) KVT-I on depressio

Not Applicable

• Conditions: F32.0; F33.0; F32.1; F33.1; F32.2; F33.2; F32.8; F33.8; F32.9; F33.9

• Registration Number: DRKS00030919
• Lead Sponsor: Heinrich-Heine-Universität Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Study Completion: 2023-05-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

Current depression (diagnostic interview & Beck Depression Inventory [BDI] > 8).
- Self-reported sleep difficulties (diagnostic interview & ISI > 10)
- Confident use of the smartphone/tablet/computer
- Stable Internet access

Exclusion Criteria

- Bipolar disorder
- Epilepsy
- Pregnancy
- Presence of another sleep disorder (diagnostic interview)
- 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
Depression severity, post-treatment (12 weeks post-randomization) as measured with the Patient Health Questionnaire (PHQ-9).

Secondary Outcome Measures

Name	Time	Method
- Insomnia severity (ISI; 12 & 24 weeks post-randomization)<br>- Daytime sleepiness (ESS; 12 & 24 weeks post-randomization)<br>- Fatigue (FSS; 12 & 24 weeks post-randomization)<br>- Quality of life (WHQOL_BREF; 12 & 24 weeks post-randomization)<br>- Emotional state (PANAS; 12 & 24 weeks post-randomization)<br>- Sleep continuity (sleep diary; continuously for 12 weeks)<br>- Self-efficacy (PCS; 12 & 24 weeks post-randomization)<br>- Emotion regulation (RSQ; 12 & 24 weeks post-randomization)