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Tests treatment safety and results for Insomnia Disorders
Official title Comparative Efficacy of BRT and CBT-I for Insomnia
ClinicalTrials.gov ID: NCT06767137
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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) to understand all study-related information.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Canton of Bern, Switzerland
- Geneva, Canton of Geneva, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Canton of Bern, Switzerland; Geneva, Canton of Geneva, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.