F51.0
Conditions
Interventions
Group 1: Patients with non-organic insomnia receive a CBT-I group therapy (8 sessions) and additionally in this context sleep education.
Group 2: Patients with non-organic insomnia receive a CBT-I gro
Sponsors
Universitätsklinikum Freiburg Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with insomnia who participated in our DFG-funded study "Emotional regulation in insomnia" and gave their consent to be contacted again for further studies will be contacted again. If they are interested, inclusion and exclusion criteria will be checked. If the planned target sample size won't be reached through our previous DFG-funded study, further participants will be recruited (e.g., through our sleep laboratory). Inclusion criteria: - meeting research diagnostic criteria for insomnia disorder according to DSM 5 (American Psychiatric Association 2013) - age > 18 years - written informed consent
Exclusion criteria
Exclusion criteria: - presence of any other psychiatric diagnosis or any relevant medical/neurological disorder as identified through standard clinical interview – suicidality – abuse or dependency of alcohol, medication or any illegal substance within the past year – sleep disorders except insomnia disorder – intake of sleep medication 2 weeks prior to and during the study treatment – insufficient fluency in German
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI) (Bastien et al" 2001, Sleep Med). Self report. Measured 2 weeks before therapy start, at therapy start, immediately after therapy end, 3 months after therapy end, and 6 months after therapy end. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep-related parameters: - subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI) - Consensus Sleep Diary - Sleep behaviour (Sleep Hygiene Index, SHI) - Sleep Effort (Glasgow Sleep Effort Scale, GSES) - sleep-related quality of life (Glasgow Sleep Impact Index) - dysfunctional beliefs and attitudes about sleep (DBAS-16) - Pre-Sleep Arousal Scale (PSAS) - Daytime Sleepiness (Epworth Sleepiness Scale, ESS) - Ford Insomnia Response to Stress Test (FORD) Health-related / psychological parameters: - Depression (Beck Depression Inventory, BDI) - Anxiety (State-Trait Anxiety Inventory, STAI) - Psychological flexibility (Acceptance and Action Questionnaire) - Use of emotion regulation strategies (Ecological Momentary Assessment study, EMA): Emotion Regulation Questionnaire (ERQ), Berkley Expressivity Questionnaire (BEQ), Inventory of Cognitive Affect Regulation Strategies (ICARUS), Difficulties in Emotion Regulation Scale (DERS) - perfectionism (Frost Multidimensional Perfectionism Scale, FMPS) Physiological data: - Electrocardiography and actigraphy (ECG and activity sensor, EMA-study) - Epigenetic data (optional) Intervention-related parameters: - negative effects of psychotherapy (Negative Effects Questionnaire, NEQ) - treatment adherence (Treatment Adherence Rating Scale - Therapist Report, TARS-TR) - adverse events - medication status | — |
Countries
Germany
Contacts
Public ContactAnna Johann
UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed