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The Effect of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Neurobiological Mechanisms of Insomnia

The Effect of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Neurobiological Mechanisms of Insomnia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00018839
Enrollment
20
Registered
2019-09-18
Start date
2021-12-05
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

Interventions

Group 1: Patients with insomnia will be treated with CBT-I and will undergo MRI measurement before and after treatment.

Sponsors

Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: - written informed consent - meeting research diagnostic criteria for insomnia disorder according to DSM 5 - Age between 18 and 65 years

Exclusion criteria

Exclusion criteria: - unstable, progressive or degenerative medical condition - acute pain or poorly managed chronic pain, if causally linked to insomnia - suicidality - uncontrolled psychiatric condition requiring immediate treatment outside of study - abuse or dependency of alcohol, medication or any illegal substance within the past year - vidence of sleep disorders except insomnia disorder (i.e., AHI>15, PLMS index with arousal > 5) - evidence of intellectual disability - intake of sleep medication 2 weeks prior to and during the study treatment until the last therapy session - other psychotherapy within the last 3 years - history of brain damage - MRI contraindications - pregnancy and lactation period - insufficient fluency in German to complete the protocol

Design outcomes

Primary

MeasureTime frame
Measurement of BOLD-signal and GABA levels in brain regions using fMRI and MRS before and after treatment

Secondary

MeasureTime frame
Questionnaires before and after treatment with outcome parameters regarding subjective sleep efficacy, sleep behavior, sleep effort, sleep-related quality of life, psychological flexibility and use of emotion regulation strategies

Countries

Germany

Contacts

Public ContactKai Spiegelhalder

Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie

Kai.Spiegelhalder@uniklinik-freiburg.de0761/27065890

Outcome results

None listed

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