G47.0
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Difficulty falling asleep or staying asleep, with at least moderate severity (> 10 points on the ISI) - Very good knowledge of German (spoken and written)
Exclusion criteria
Exclusion criteria: - Psychotic/bipolar disorder - IQ < 85 (estimated) - Acute suicidal tendencies/substance dependence - Severe physical illnesses that impair learning ability (e.g., neurological disorders, traumatic brain injury, degenerative neurological disease) - Organic cause of sleep disorder (e.g., sleep apnea syndrome, restless leg syndrome) - External cause of sleep disorder (e.g., pregnancy, nighttime breastfeeding, co-sleeping with infant/toddler, shift work with night shifts, regular intercontinental flights) - Use of medications that affect sleep structure (e.g., benzodiazepines/opiates); medication for sleep disorders must be discontinued before participating in the study or switched to an antidepressant in a sleep-inducing dosage. The medication must be maintained at a stable dosage throughout the study period. - During study participation: no PME/relaxation group, no intensive individual psychotherapy, no other group therapy, no communication of sleep topics in supportive contact, no therapy apps for sleep disorders or similar.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the severity of sleep disturbance, assessed by the Insomnia Severity Index (ISI) at the follow-up assessment (3 months after the end of treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include objective sleep quality (polysomnography assessed using home sleep tests (SOMNOmedics©)), sleep-related metacognitions (assessed using the Metacognitions Questionnaire - Insomnia (MCQ-I)), sleep-related cognitions (assessed using the Dysfunctional Beliefs and Attitudes About Sleep Scale-16 (DBAS-16)), chronotype and social jet lag (assessed using the Chronotype Questionnaire (D-MEQ) and the Munich ChronoType Questionnaire (MCTQ)), self-related learning (assessed using the Learning of Own Performance Task (LOOP)), quality of life (assessed using the World Health Organization-Five Well-Being Index (WHO-5)), psychosocial functioning (measured using the Work and Adjustment Scale (WSAS)), and other questionnaires. Data collection takes place at baseline, post-treatment, follow-up (3 months after the end of treatment), and at the beginning of each group therapy session (only ISI, MCQ-I, DBAS-16). | — |
Countries
Germany
Contacts
Zentrum für Psychiatrie und Psychotherapie, Lübeck; Universität zu Lübeck