Health TrialsbyHealthPanel

Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

ConditionsInsomniaInsomnia ChronicInsomnia, PrimaryBlood PressureBlood Pressure, High
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 site.

Meets criteria for chronic insomnia

Body Mass Index (BMI) 18.5 kg/m2 and higher

Disqualifiers

Age < 18

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 site.

Unwilling to share email address/cell phone number to accept survey links.

Life time diagnosis of psychotic or bipolar disorder

Trial design

Design model

Sequential

Treatments tested in this trial

  • Cognitive Behavioral Treatment for Insomnia (CBT-I)

    Behavioral

    Subjects will receive therapy for 8 weeks

  • Trazodone

    Drug

    Non-remitting subjects will receive Trazodone (dosage) for 8 weeks

  • Placebo

    Other intervention

    Non-remitting subjects will receive placebo for 8 weeks

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placeboPlacebo comparator 2 interventions
Group B: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with TrazodoneActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)

Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe

Time frame
9 weeks
2

Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)

Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe

Time frame
9 weeks
3

Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment

Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe

Time frame
35 weeks

Secondary outcomes

1

Insomnia Severity Index (ISI) Score following CBT-I

0-28, with 0 being mild and 28 being severe

Time frame
9 weeks
2

Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)

Polysomnography (PSG) Sleep efficiency measured as a percentage of time asleep during sleep study

Time frame
9 weeks
3

Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)

Actigraphy Sleep efficiency measured as estimated sleep time at home (2 week period)

Time frame
9 weeks
4

Evening Cortisol levels following CBT-I

Cortisol levels measured in saliva collected following CBT-I

Time frame
9 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Milton S. Hershey Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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