Efficacy of digital cognitive-behavioural psychotherapy for the treatment of insomnia (dCBT-I) in comorbid chronic pain

Efficacy of digital cognitive-behavioural psychotherapy for the treatment of insomnia (dCBT-I) in comorbid chronic pain - ONSET_pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00030972

Enrollment

204

Registered

2023-01-06

Start date

2023-01-30

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F51.0 F45.41

Interventions

Group 1: Intervention group: Digital cognitive behavioural therapy for insomnia (dCBT-I). The somnio therapy programme consists of 11 modules, which vary in length (approx. 20 minutes on average, appr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis F51.0 Diagnosis F45.41

Exclusion criteria

Exclusion criteria: Excessive alcohol/drug use; suicidality; Schizophrenia/acute psychosis; Epilepsy

Design outcomes

Primary

Measure	Time frame
Insomnia: ISI Insomnia Severity Index (Pre, Post, Follow-up 6 months)	—

Secondary

Measure	Time frame
- Pain symptoms: German Pain Questionnaire (DSF), Multidimensional Pain Inventory (MPI) (baseline, 8 and 24 weeks). - Daytime sleepiness: Epworth Sleepiness Scale (ESS) (baseline, 8 and 24 weeks) - Fatigue: Fatigue Severity Scale (FSS) (baseline, 8 and 24 weeks) - Dysfunctional attitudes to sleep: Opinions About Sleep Questionnaire (DBAS) (baseline, 8 and 24 weeks) - Well-being. WHO-5 Well-Being Index (WHO-5) (baseline, 8 and 24 weeks) - Quality of life: WHO Quality of Life (WHOQOL_BREF) (baseline, 8 and 24 weeks) - Psychological Need Satisfaction: Basic Psychological Need Satisfac-tion and Frustration Scale (BPNSFS) (baseline, 8 and 24 weeks). - Dreams and nightmares: Mannheim Dream Questionnaire (MADRE), Nightmare Distress Questionnaire (NDQ) (baseline, 8 and 24 weeks) - Depression and anxiety: General Depression Scale (ADS-K); State-Trait Anxiety Inventory (STAI) (baseline, 8 and 24 weeks) - Analysis of motivational schemas: Questionnaire for Analysis of Motivational Schemas (FAMOS); Incongruence Questionnaire (K-INK) (FAMOS: Baseline K-INK: Baseline, 8 and 24 weeks)	—

Measure

Time frame

- Pain symptoms: German Pain Questionnaire (DSF), Multidimensional Pain Inventory (MPI) (baseline, 8 and 24 weeks). - Daytime sleepiness: Epworth Sleepiness Scale (ESS) (baseline, 8 and 24 weeks) - Fatigue: Fatigue Severity Scale (FSS) (baseline, 8 and 24 weeks) - Dysfunctional attitudes to sleep: Opinions About Sleep Questionnaire (DBAS) (baseline, 8 and 24 weeks) - Well-being. WHO-5 Well-Being Index (WHO-5) (baseline, 8 and 24 weeks) - Quality of life: WHO Quality of Life (WHOQOL_BREF) (baseline, 8 and 24 weeks) - Psychological Need Satisfaction: Basic Psychological Need Satisfac-tion and Frustration Scale (BPNSFS) (baseline, 8 and 24 weeks). - Dreams and nightmares: Mannheim Dream Questionnaire (MADRE), Nightmare Distress Questionnaire (NDQ) (baseline, 8 and 24 weeks) - Depression and anxiety: General Depression Scale (ADS-K); State-Trait Anxiety Inventory (STAI) (baseline, 8 and 24 weeks) - Analysis of motivational schemas: Questionnaire for Analysis of Motivational Schemas (FAMOS); Incongruence Questionnaire (K-INK) (FAMOS: Baseline K-INK: Baseline, 8 and 24 weeks)

—

Countries

Germany

Contacts

Public ContactJennifer Schuffelen

Heinrich-Heine-Universität Düsseldorf

jennifer.schuffelen@hhu.de+49 211 81-10584

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026