Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06767137

Comparative Efficacy of BRT and CBT-I for Insomnia

Led by Christoph Nissen · Updated on 2025-02-17

160

Participants Needed

2

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comparative Efficacy of BRT and CBT-I for Insomnia

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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 planned alteration during the trial period (stable medication except BZD or BZDRA does not lead 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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Universität Bern, Psychotherapeutische Praxisstelle

Bern, Canton of Bern, Switzerland, 3012

Actively Recruiting

2

Service des specialités psychiatriques, Hôpitaux universitaires de Genève

Geneva, Canton of Geneva, Switzerland, 1201

Actively Recruiting

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Research Team

E

Elisabeth Hertenstein, PD, PhD

CONTACT

M

Marie Angelillo, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Comparative Efficacy of BRT and CBT-I for Insomnia | DecenTrialz