RecruitingEARLY_PHASE1INTERVENTIONAL

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

This research is investigating two common ways to treat insomnia: a talking therapy called Cognitive Behavioral Therapy for Insomnia (CBT-I) and a low dose of a medication called trazodone. The study wants to understand if these treatments work differently for people who get very little sleep due to insomnia compared to those who get a normal amount of sleep but still struggle with insomnia. Researchers are also looking at how these treatments might affect blood pressure. The goal is to provide doctors with better guidelines so they can choose the most effective treatment for each person with insomnia, potentially reducing related health problems.

At a glance

Status

Recruiting

Phase

EARLY_PHASE1

Sponsor

Milton S. Hershey Medical Center

Enrolment target

600

Start

20 Mar 2024

Estimated completion

31 May 2028

Insomnia Insomnia Chronic Insomnia, Primary Blood Pressure Blood Pressure, High

What is this study about?

If you have trouble sleeping, you're not alone. This study is all about helping people with insomnia. Researchers know that not everyone with insomnia is the same – some people hardly get any sleep (`short sleep duration`), while others might get enough sleep hours but still feel tired and have difficulty sleeping (`normal sleep duration`). These different groups might react differently to treatments.

This study is comparing two well-known approaches to managing insomnia. One is Cognitive Behavioral Therapy for Insomnia, often called CBT-I for short. This is a type of talking therapy that helps you change thoughts and behaviours that keep you from sleeping well. The other treatment being looked at is a medication called trazodone, used at a low dose. Trazodone is a commonly prescribed medicine that doesn't usually cause dependency, unlike some other sleep aids.

The main aim is to see if one of these treatments works better for a particular type of insomnia, or if they both work well for everyone. They're also checking to see how these treatments might affect your blood pressure. The hope is that the results will help doctors make better decisions about which treatment to suggest to their patients, leading to more effective relief from insomnia and potentially helping with other health issues like high blood pressure.

Key takeaways

This study compares two insomnia treatments: CBT-I (talking therapy) and low-dose trazodone (medication).
It aims to find out which treatment works best for different types of insomnia and effects on blood pressure.
Participation involves assessments, potential therapy or medication/placebo, and monitoring.
You must be 18+, have chronic insomnia, and a BMI of 18.5 or higher.
You cannot participate if you have certain severe health conditions, are pregnant/breastfeeding, or are taking other sleep medications.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be 18 years old or older and be able to speak and understand English. You must have long-term insomnia and your body mass index (BMI) needs to be 18.5 or higher. The study is open to both men and women.

There are some reasons why you might not be able to join. For example, if you're under 18, have certain serious mental health conditions like a history of psychosis or bipolar disorder, or have severe untreated sleep apnea, this study might not be suitable. Also, if you've recently changed sleep apnea treatment or have certain serious ongoing health issues like kidney, liver, or heart failure, or are currently receiving chemotherapy or radiation, you wouldn't be able to participate. Pregnancy or breastfeeding would also exclude you, as would not being willing to use contraception if you could become pregnant.

Finally, if you've had substance abuse in the last year, are taking other prescription or over-the-counter sleep medications more than twice a week, or using certain long-term medications like corticosteroids or strong pain relievers (opioids), you wouldn't be eligible. You also can't be getting other insomnia treatments while taking part in this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have ongoing problems with insomnia?
Is your Body Mass Index (BMI) 18.5 or higher?
Are you able to comfortably read and understand English?
Do you *not* have a history of serious mental health conditions like psychosis or bipolar disorder?
Are you *not* currently pregnant or breastfeeding, and willing to use contraception if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the full details would be explained to you. It would involve several visits and assessments to monitor your sleep and blood pressure. You would either receive Cognitive Behavioral Therapy for Insomnia (CBT-I), which is a type of talking therapy, or a low dose of the medication called trazodone, or a placebo (a dummy pill with no active ingredient). The researchers would monitor how these treatments affect your sleep patterns and your blood pressure over a period of time. You would have regular check-ups and might need to fill out questionnaires about your sleep and well-being. The total length of your participation in the study would be clearly explained to you.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of joining this study is that you might receive a treatment that could improve your sleep and potentially help with your blood pressure. You would also be contributing valuable information that could help others with insomnia in the future. As for risks, you might experience side effects from the medication (trazodone) or find the talking therapy challenging. You might also be in the placebo group, meaning you wouldn’t get active treatment, and your symptoms might not improve. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

National Jewish Health
Verified postcode
Denver, United States· Recruiting
Penn State University
Verified postcode
Hershey, United States· Recruiting
University of Pittsburgh
Verified postcode
Pittsburgh, United States· Recruiting
Université Laval
Verified postcode
Québec, Canada· Recruiting

Common questions

What is CBT-I?

CBT-I stands for Cognitive Behavioral Therapy for Insomnia. It's a type of talking therapy that helps you change thoughts and habits that can make it hard to sleep.

What is trazodone?

Trazodone is a medication that doctors sometimes prescribe for sleep. In this study, it's used at a low dose and is not considered habit-forming.

What is a placebo?

A placebo is a 'dummy' pill that looks like the real medication but has no active ingredients. It helps researchers see if a medicine really works, or if people feel better just because they think they're getting treatment.

Will I know which treatment I am getting?

Usually in studies like this, participants are 'blinded,' meaning you won't know if you're getting the active medication or the placebo until after the study is over. This helps make the study results more reliable.

Can I continue my regular sleep medication if I join?

No, if you join this study, you would need to agree to not use any other treatments for insomnia beyond what the study provides.

How to find out more

Carrie Criley

ccriley@pennstatehealth.psu.edu 717-531-4123 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.