Comparative Efficacy of BRT and CBT-I for Insomnia

Last updated: February 13, 2025
Sponsor: Christoph Nissen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Anxiety Disorders

Treatment

Bedtime restriction (BRT)

Cognitive behavioral therapy for insomnia (CBT-I)

Clinical Study ID

NCT06767137
2024-01324
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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) tounderstand all study-related information.

Exclusion

Exclusion Criteria:

  • Unstable, progressive, or degenerative medical condition

  • Acute pain or poorly managed chronic pain

  • Suicidality

  • Uncontrolled psychiatric condition requiring treatment outside of study

  • Alcohol or drug abuse or dependency

  • 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)

  • Evidence of intellectual disability

  • Regular intake of benzodiazepines (BZD) or benzodiazepine receptor agonists (BZDRA)

  • Alteration of medication within 4 weeks prior to study treatment or plannedalteration during the trial period (stable medication except BZD or BZDRA does notlead to exclusion)

  • 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

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Bedtime restriction (BRT)
Phase:
Study Start date:
March 10, 2025
Estimated Completion Date:
November 01, 2027

Connect with a study center

  • Universität Bern, Psychotherapeutische Praxisstelle

    Bern, 3012
    Switzerland

    Active - Recruiting

  • Service des specialités psychiatriques, Hôpitaux universitaires de Genève

    Geneva, 1201
    Switzerland

    Active - Recruiting

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