CBT + Trazodone for Insomnia

Recruiting at 3 trial locations

Overseen By Carrie Criley

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Milton S. Hershey Medical Center

Must be taking: Antihypertensives

Must not be taking: Corticosteroids, Opiates, others

Disqualifiers: Psychotic, Bipolar, Narcolepsy, others

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. ^{1 2 3 4 5}

Is 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. ^{2 4 6 7 8}

How 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. ^{1 2 4 5 9}

Research Team

Alexandros Vgontzas, MD

Principal Investigator

Professor, Psychiatry

Eligibility 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

Body Mass Index (BMI) 18.5-<40 kg/m2

I can read and communicate effectively in English or French (in Canada).

I have been diagnosed with chronic insomnia.

Exclusion Criteria

I am not willing to share my contact details for surveys.

Unstable medical conditions that would make participation unsafe or unfeasible

I am under 18 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Behavioral Therapy for Insomnia (CBT-I) for 8 weeks. Non-remitting subjects then receive either trazodone or placebo for an additional 8 weeks.

16 weeks

Follow-up

Participants are monitored for remission of insomnia symptoms and other secondary outcomes such as cortisol levels and blood pressure.

35 weeks

Treatment Details

Interventions

• Cognitive Behavioral Treatment for Insomnia (CBT-I) (Behavioural Intervention)
• Placebo (Other)
• Trazodone (Other)

Trial Overview 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.

Participant Groups

Group I: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone Active Control 2 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 placebo Placebo Group 2 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.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Cognitive-behavioral therapy for insomnia (CBT-I) showed positive effects on sleep quality and depressive symptoms in a study of 30 psychiatric outpatients, with 38% achieving normal sleep after treatment.

While CBT-I led to significant improvements within the treatment group over 4 and 8 weeks, there were no significant differences when compared to the control group, suggesting that while beneficial, the effects may not be strong enough to outperform standard care alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. Wagley, JN., Rybarczyk, B., Nay, WT., et al.[2022]

Cognitive Behaviour Therapy (CBT) alone and in combination with trazodone is effective for treating chronic primary insomnia, as shown in a study of 20 outpatients over 8 weeks, with significant improvements in sleep latency, efficiency, and total sleep time.

The combination of CBT and trazodone notably increased slow wave sleep duration compared to CBT alone, suggesting that trazodone enhances sleep quality independently of its antidepressant effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trazodone improves the results of cognitive behaviour therapy of primary insomnia in non-depressed patients. Zavesicka, L., Brunovsky, M., Horacek, J., et al.[2018]

Cognitive behavioral therapy for insomnia (CBT-I) is recognized as the first-line treatment for both uncomplicated insomnia and insomnia associated with other chronic disorders, demonstrating its broad efficacy.

This review aims to summarize efficacy data across various clinical and demographic factors and to outline future research and implementation strategies for CBT-I, highlighting its importance in treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? Muench, A., Vargas, I., Grandner, MA., et al.[2022]

Cognitive-behavioral therapy for insomnia (CBT-I) is the preferred treatment for chronic insomnia, but it faces challenges such as a lack of trained therapists and a low response rate among patients.

Alternative methods to CBT-I, including bibliotherapy, phone psychotherapy, brief behavioral therapy, and online CBT-I, are gaining interest, and hypnotics can be used alongside CBT-I to enhance its effectiveness or as a standalone treatment when CBT-I is not accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. Pchelina, PV., Poluektov, MG.[2019]

Cognitive-behavioral therapy for insomnia (CBT-I) is recognized as the best treatment for chronic insomnia, yet it is significantly underutilized despite the high number of people affected by insomnia disorder.

The article highlights the need for further research on how to effectively deliver CBT-I, identify suitable candidates for the therapy, and measure the quality of care provided, which are essential for improving its real-world application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. Buenaver, LF., Townsend, D., Ong, JC.[2019]

Cognitive behavioral therapy for insomnia (CBT-I) significantly improves insomnia symptoms, with 36% of patients achieving remission compared to only 16.9% in control groups, indicating its efficacy for those with comorbid conditions.

CBT-I shows medium to large effect sizes for various sleep parameters, such as sleep efficiency and sleep onset latency, and has a small positive effect on comorbid symptoms, particularly benefiting patients with psychiatric conditions more than those with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. Wu, JQ., Appleman, ER., Salazar, RD., et al.[2022]

Cognitive Behavioral Therapy for insomnia (CBT-i) is an effective first-line treatment for chronic insomnia, showing significant improvements in sleep onset latency (SOL) by about 19 minutes and wake after sleep onset (WASO) by about 26 minutes based on a review of 20 studies involving 1162 participants.

The benefits of CBT-i, which includes techniques like cognitive therapy and sleep hygiene, appear to be sustained over time, and importantly, no adverse effects were reported, making it a safe alternative to pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Trauer, JM., Qian, MY., Doyle, JS., et al.[2022]

Cognitive behavior therapy for insomnia (CBT-I) shows moderate to large treatment effects (Cohen's d range of 0.35-2.2) for patients with insomnia related to various medical and psychiatric conditions, indicating its efficacy beyond primary insomnia.

Improving sleep through CBT-I may also lead to better outcomes in managing comorbid medical and psychological conditions, highlighting the need for further research on adapting CBT-I for specific disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Smith, MT., Huang, MI., Manber, R.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective treatment for insomnia, even in patients with various co-occurring mental health and medical conditions.

The article reviews the evidence supporting the use of CBT-I in these populations and discusses important considerations for its application, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in Patients with Medical and Psychiatric Comorbidities. Raglan, GB., Swanson, LM., Arnedt, JT.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]

2. Sweden pubmed.ncbi.nlm.nih.gov

Trazodone improves the results of cognitive behaviour therapy of primary insomnia in non-depressed patients. [2018]

3. England pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? [2022]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in Patients with Medical and Psychiatric Comorbidities. [2019]