Comparing two talking and sleep-habit treatments for adults with insomnia
Tests whether bedtime restriction works as well as cognitive behavioral therapy in insomnia.
Key facts
- Who runs it
- Christoph Nissen
- Where
- Switzerland2 sites in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Comparative Efficacy of BRT and CBT-I for Insomnia
- Status
- Recruiting
- People taking part
- 160 people, planned
- Started
- 10 Mar 2025
- Expected to end
- 1 Nov 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- Cognitive behavioral therapy for insomnia (CBT-I)
- Bedtime restriction (BRT)
- Record updated
- 17 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with insomnia disorder. It compares two talk-and-habit therapies for sleep: Bedtime Restriction Therapy (BRT) and CBT-I.
- Age
- 18 to 80 years
- Sex
- All sexes
- Disease stage
- Insomnia disorder as defined by DSM-5 criteria.
- Earlier treatment
- People who regularly take benzodiazepines (BZD) or benzodiazepine receptor agonists (BZDRA) cannot join. Medicines must not have changed in the 4 weeks before the study, and no changes may be planned during it. No other current psychotherapy for insomnia.
Main reasons for not taking part
- Unstable, worsening or degenerative illness, or acute or poorly controlled chronic pain
- Suicidal thoughts, or uncontrolled mental illness needing treatment outside the study
- Psychosis, bipolar disorder, autism, borderline or antisocial personality disorder, or intellectual disability
- Other sleep disorders, such as sleep apnea or restless legs
- Alcohol or drug abuse, known pregnancy or breastfeeding, or not fluent enough in German or French
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Must meet DSM-5 criteria for insomnia disorder
- Adults aged 18 to 80 years
- Capable of giving written informed consent
- Sufficient fluency in the study site's language (i.e., German or French) to understand all study-related information
Who cannot take part
- Alcohol or drug abuse or dependency
- Alteration of medication within 4 weeks prior to study treatment or planned alteration during the trial period (stable medication except BZD or BZDRA does not lead to exclusion)
- Unstable, progressive, or degenerative medical condition
- Uncontrolled psychiatric condition requiring treatment outside of study
- Diagnosis of psychosis, bipolar disorder, autism, borderline personality disorder, or antisocial personality disorder
- Clinical evidence of sleep disorders other than insomnia (e.g., sleep apnea, restless legs, periodic limb movements in sleep, parasomnia)
- Acute pain or poorly managed chronic pain
- Suicidality
- Evidence of intellectual disability
- Regular intake of benzodiazepines (BZD) or benzodiazepine receptor agonists (BZDRA)
- Current other psychotherapy for insomnia
- Known pregnancy or breastfeeding
- Inability to comply with study procedure
- Insufficient fluency in German or French to complete the study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This study evaluates two behavioral treatments for patients with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Both therapies aim to improve the clinical symptomatology of insomnia by teaching participants techniques to better manage their sleep schedule and habits. BRT is a simpler and shorter therapy focused on aligning the time spent in bed with reported sleep time. CBT-I includes additional components such as relaxation techniques and cognitive exercises. The study will compare these treatments to see if BRT is as effective as CBT-I in improving the clinical symptomatology of insomnia.
The 2 groups in the trial
- Cognitive behavioral therapy for insomnia (CBT-I)Treatment being tested
- Bedtime restriction (BRT)Treatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial
- Plain-language title
- Comparing two talking and sleep-habit treatments for adults with insomniaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06767137, who can take part
- Record updated
- 17 February 2025