CBT + Trazodone for Insomnia
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Milton S. Hershey Medical Center
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot use medications for sleep more than twice a week, systemic corticosteroids, opiates, or any medications that don't mix well with trazodone. You must also continue your anti-hypertensive medication if you're on it.
What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) combined with Trazodone for treating insomnia?
Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for treating insomnia and is considered the first-line treatment. Additionally, combining CBT-I with Trazodone, a medication often used to help with sleep, can improve treatment outcomes for primary insomnia.
12345Is the combination of CBT-I and Trazodone safe for treating insomnia?
Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally considered safe and is recommended as a first-line treatment for chronic insomnia due to its lack of adverse effects. Trazodone, often used alongside CBT-I, is a sedative antidepressant that is commonly prescribed for insomnia and is generally well-tolerated, though it may have some side effects like drowsiness or dizziness.
24678How is the treatment of CBT + Trazodone for insomnia different from other treatments?
CBT + Trazodone for insomnia is unique because it combines cognitive behavioral therapy (a structured program to change sleep habits) with trazodone, a medication often used to enhance the effects of therapy. This combination aims to improve sleep by addressing both behavioral and chemical aspects of insomnia, which may be more effective than using either approach alone.
12459Eligibility Criteria
This trial is for adults with chronic insomnia, particularly those who sleep less than normal (ISS) or have a normal sleep duration (INS), and also have high blood pressure. Participants should not be currently using other treatments for insomnia.Inclusion Criteria
I am 18 years old or older.
Exclusion Criteria
I am under 18 years old.
I have never been diagnosed with a psychotic or bipolar disorder.
I have been diagnosed with narcolepsy or hypersomnia.
I have not had a fall causing hospitalization or serious injury in the last year.
I've been hospitalized or visited the ER twice in the last year for a chronic condition.
I am currently receiving chemotherapy or radiation for my cancer.
I have been diagnosed with sleep apnea or leg movement disorder.
I am currently using a PAP machine for my sleep.
I do not have chronic insomnia.
I have never been diagnosed with or treated for chronic kidney failure, liver problems, or chronic heart failure.
I agree to only use the insomnia treatments provided in this study.
I use sleep medication more than twice a week.
I am currently taking steroids or opiate painkillers.
I am not taking any medications that can't be used with trazodone.
Participant Groups
The study tests Cognitive Behavioral Therapy for Insomnia (CBT-I), which is a non-drug treatment focusing on changing sleep habits, versus Trazodone, a low-dose medication that helps with sleep without forming habits. The effectiveness of these treatments will be compared.
2Treatment groups
Active Control
Placebo Group
Group I: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with TrazodoneActive Control2 Interventions
Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.
Group II: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placeboPlacebo Group2 Interventions
Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
National Jewish HealthDenver, CO
Penn State UniversityHershey, PA
University of PittsburghPittsburgh, PA
Université LavalQuebec, Canada
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Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]To test the efficacy of cogntive-behavioral therapy for insomnia (CBT-I) as a supplement treatment for psychiatric outpatients. Comorbid insomnia is prevalent among individuals with varied psychiatric disorders and evidence indicates that CBT-I may be effective for reducing insomnia and other psychiatric symptoms.
Trazodone improves the results of cognitive behaviour therapy of primary insomnia in non-depressed patients. [2018]Cognitive behaviour therapy (CBT) of primary insomnia is frequently combined with various pharmacological treatments, including sedative antidepressants. The present study was undertaken to evaluate the clinical efficacy of CBT, singly and combined with trazodone pharmacotherapy, for primary insomnia.
We know CBT-I works, now what? [2022]Cognitive behavioral therapy for insomnia (CBT-I) has been shown to be efficacious and now is considered the first-line treatment for insomnia for both uncomplicated insomnia and insomnia that occurs comorbidly with other chronic disorders (comorbid insomnia). The purposes of this review are to provide a comprehensive summary of the efficacy data (for example, efficacy overall and by clinical and demographic considerations and by CBT-I formulation) and to discuss the future of CBT-I (for example, what next steps should be taken in terms of research, dissemination, implementation, and practice).
[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019]Cognitive-behavioral therapy for insomnia (CBT-I) is the treatment of choice for chronic insomnia. Together with advantages it has such limitations like shortage of trained staff and low response rate. That is why the alternative methods of CBT-I induce high interest: bibliotherapy, phone psychotherapy, brief behavioral therapy and online-CBT-I. Hypnotics administration is recommended as adjuvant to extent the CBT-I effect. It may also be used as monotherapy when CBT-I is unavailable.
Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. [2019]Cognitive-behavioral therapy for insomnia (CBT-I) has emerged as the first-line treatment for chronic insomnia but remains massively underused relative to the prevalence of insomnia disorder. This article focuses on 3 key issues in the delivery of CBT-I in the real world. First, where and how should CBT-I be delivered and who should deliver it? Second, who is an appropriate candidate for CBT-I? Third, how do you measure quality care with CBT-I? These issues give rise to targets for future research aimed at improving the implementation science of CBT-I in the real world.
Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]Cognitive behavioral therapy for insomnia (CBT-I) is the most prominent nonpharmacologic treatment for insomnia disorders. Although meta-analyses have examined primary insomnia, less is known about the comparative efficacy of CBT-I on comorbid insomnia.
Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]Because psychological approaches are likely to produce sustained benefits without the risk for tolerance or adverse effects associated with pharmacologic approaches, cognitive behavioral therapy for insomnia (CBT-i) is now commonly recommended as first-line treatment for chronic insomnia.
Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]Insomnia is a pervasive problem for many patients suffering from medical and psychiatric conditions. Even when the comorbid disorders are successfully treated, insomnia often fails to remit. In addition to compromising quality of life, untreated insomnia may also aggravate and complicate recovery from the comorbid disease. Cognitive behavior therapy for insomnia (CBT-I) has an established efficacy for primary insomnia, but less is known about its efficacy for insomnia occurring in the context of medical and psychiatric conditions. The purpose of this article is to present a rationale for using CBT-I in medical and psychiatric disorders, review the extant outcome literature, highlight considerations for adapting CBT-I procedures in specific populations, and suggest directions for future research. Outcome studies were identified for CBT-I in mixed medical and psychiatric conditions, cancer, chronic pain, HIV, depression, posttraumatic stress disorder, and alcoholism. Other disorders discussed include: bipolar disorder, eating disorders, generalized anxiety, and obsessive compulsive disorder. The available data demonstrate moderate to large treatment effects (Cohen's d, range=0.35-2.2) and indicate that CBT-I is a promising treatment for individuals with medical and psychiatric comorbidity. Although the literature reviewed here is limited by a paucity of randomized, controlled studies, the available data suggest that by improving sleep, CBT-I might also indirectly improve medical and psychological endpoints. This review underscores the need for future research to test the efficacy of adaptations of CBT-I to disease specific conditions and symptoms.
Cognitive Behavioral Therapy for Insomnia in Patients with Medical and Psychiatric Comorbidities. [2019]"Insomnia is highly comorbid with other mental health and medical conditions and adversely affects quality of life and daytime functioning. Cognitive behavioral therapy for insomnia (CBT-I) is a safe and efficacious treatment for insomnia in the context of various comorbid conditions. In this article, the authors outline considerations for delivering CBT-I in patients with the most common co-occurring medical and mental health conditions, review the evidence for CBT-I in these populations as well as special considerations for its application, and highlight future areas for research in the area of CBT-I for comorbid medical and psychiatric conditions."