Testing Cognitive Behavioral Treatment for with Trazodone against a placebo for insomnia
Official title: Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial
Interventions
Cognitive Behavioral Treatment for Insomnia (CBT-I)
Subjects will receive therapy for 8 weeks
Trazodone
Non-remitting subjects will receive Trazodone (dosage) for 8 weeks
Placebo
Non-remitting subjects will receive placebo for 8 weeks
Canadian Sites (1)
Université Laval
Québec, Quebec, Canada
Eligibility Criteria
See who this study is looking for27 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age 18 or older
- +Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian siteTrial siteA hospital or clinic where a study is actually run.Read more →.
- +Meets criteria for chronic insomnia
- +Body Mass Index (BMI) 18.5 kg/m2 and higher
Exclusion
- −Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian siteTrial siteA hospital or clinic where a study is actually run.Read more →.
- −Unwilling to share email address/cell phone number to accept survey links.
- −Life time diagnosis of psychotic or bipolar disorder
- −Started new or changed treatment for sleep apnea in the past three months
- −Does not meet criteria for chronic insomnia
- −Meets criteria for narcolepsy or hypersomnia disorder
- −Meets criteria for circadian rhythm disorder (including night shift work)
- −Unstable medical conditions that would make participation unsafe or unfeasible
- −Falls resulting in hospitalization, significant injury or fracture within past 12 months
- −2 hospitalizations or emergency room visits within past 12 months for chronic conditions
- −Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure
- −Does not agree to refrain from other treatments for insomnia beyond what is offered in this study
- −BMI less than 18.5
- −Substance abuse or dependence in the past 12 months
- −Current use of prescription or over the counter medications taken for sleep greater than 2 times per week
- −Current use of systemic corticosteroids or opiate medications
- −Current use of medications contraindicated with trazodone
- −Sleep apnea or periodic leg movement disorder as determined by sleep study
- −Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg
- −EKG corrected QT interval greater than or equal to 500 ms
- −Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth controlControl groupThe group a new treatment is measured against.Read more → for the length of the study
- −History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.
- −Active chemotherapy or radiation therapy for cancer
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Early Phase 1Early Phase 1A very small, very early study of how the body handles a treatment.Read more → — the earliest human testing, in a very small group, to observe how the body handles it.
What is being given or done in this study: Cognitive Behavioral Treatment for Insomnia (CBT-I), Trazodone, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 600 people.
The study is currently expected to finish around May 2028.
The main measurement is taken over: 9 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I) — measured over 9 weeks.
Remission of insomnia symptoms following trazodone/placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → RandomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → Controlled Trial (RCT) — measured over 9 weeks.
Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment — measured over 35 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06281756 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Cognitive Behavioral Treatment for Insomnia (CBT-I)Behavioural
Subjects will receive therapy for 8 weeks
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About TrazodoneDrug
Non-remitting subjects will receive Trazodone (dosage) for 8 weeks
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboOther
Non-remitting subjects will receive placebo for 8 weeks
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 9 weeks.
The study as a whole is currently expected to finish around 2028-05-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 600 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Québec, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.