F51.0 G47.0
Conditions
Interventions
Group 1: Intervention group 1 (IG1):
Participants in IG1 are treated according to the stepped care model, i.e. patients are given access to steps 1 to 3 according to their needs.
In step 2 (internet-
Sponsors
Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Nonorganic insomnia (ICD-10: F51.0) or disorders of initiating and maintaining sleep (insomnias) (ICD-10: G47.0)
Exclusion criteria
Exclusion criteria: Untreated sleep apnea (ICD-10: G47.3); untreated restless legs syndrome / periodic limb movements in sleep (ICD-10: G25.8); untreated hyperthyroidism; currently ongoing psychotherapy for insomnia; conditions that can get worse by (i)CBT-I (bipolar disorder, ICD-10: F31.x; epilepsy and recurrent seizures, ICD-10: G40.x); diseases or circumstances that threaten the reliable use of internet and mobile-based treatment (e.g. organic, including symptomatic, mental disorders, ICD-10: F00-F09; mental and behavioral disorders due to psychoactive substance use, ICD-10: F10-F19; schizophrenia, schizotypal and delusional disorders, ICD-10: F20-F29), acute suicidal tendency. The examination of the inclusion and exclusion criteria is carried out exclusively by the general practitioner responsible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of insomnia measured by the Insomnia Severity Index (ISI) 6 months after completion of the baseline survey (T3) | — |
Secondary
| Measure | Time frame |
|---|---|
| The psychometric and health economic data are collected online in a self-report at 4 measurement points (T0: baseline; T1: after 4 weeks; T2: after 12 weeks; T3: after 6 months, in each case after completion of the baseline survey). Additional measurement dates are planned, subject to follow-up financing. Sleep-related parameters: - Reliable Change Index for the Primary Outcome - Severity of insomnia (Insomnia Severity Index, ISI) - Sleep quality (Pittsburgh Sleep Quality Index, PSQI) - Sleep-related Arousal (Pre-Sleep Arousal Scale, PSAS) - Dysfunctional Assumptions (Dysfunctional Beliefs and Attitudes About Sleep Scale, DBAS-10) - Sleep Hygiene (Sleep Hygiene Index, SHI) Health-related parameters: - Quality of Life (Assessment of Quality of Life, AQOL-8D) - Depressive symptom severity (Quick Inventory of Depressive Symptomatology, QIDS-SR16) - Incidence of clinical depression (QIDS-SR16 >= 13) in a subsample without clinical depression at T0 - Anxiety (Generalized Anxiety Disorder-7, GAD-7) - physical symptoms (Somatic Symptom Scale-8, SSS-8) - Fatigue (Letter Fatigue Inventory, BFI) - Stress (Perceived Stress Scale, PSS) - Emotion Regulation (Cognitive Emotion Regulation Questionnaire - short, CERQ-18) - direct and indirect medical and non-medical costs (German version of the TiC-P, an established self-reporting tool for recording direct and indirect costs) Intervention-related parameters: - patient satisfaction with internet- and mobile-based CBT-I (Client Satisfaction Questionnaire, adapted for internet-based interventions, CSQ-I) - Adverse Events: Reliable deterioration - Adverse Events: Side effects of internet and mobile-based CBT-I (Negative Effects Questionnaire, NEQ; other items) - therapeutic alliance with the internet and mobile-based CBT-I (Working Alliance Inventory for guided internet interventions, WAI-I) - technological alliance with the internet and mobile-based CBT-I (Technical Alliance Inventory, TAI) - reaso | — |
Countries
Germany
Contacts
Public ContactKai Spiegelhalder
Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed