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PRO*SOMNIO: Effectiveness of CBT and MCT in the treatment of sleep disorders – a randomized controlled trial

PRO*SOMNIO: Effectiveness of CBT and MCT in the treatment of sleep disorders – a randomized controlled trial - PRO*SOMNIO

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038161
Enrollment
180
Registered
2026-01-06
Start date
2026-01-16
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

G47.0

Interventions

Group 1: Cognitive behavioral therapy for sleep disorders (CBT-I): Weekly group therapy sessions over a period of six weeks. Group 2: Metacognitive therapy adapted to sleep disorders (MCT-I): Weekly g

Sponsors

Zentrum für Integrative Psychiatrie und Psychotherapie Lübeck, Universität zu Lübeck
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

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

MeasureTime 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

MeasureTime 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

Public ContactAnja Schaich

Zentrum für Psychiatrie und Psychotherapie, Lübeck; Universität zu Lübeck

anja.schaich@uksh.de+49 459 50098757

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026