Efficacy of low dose amitriptyline vs. cognitive behavioural therapy for chronic insomnia and medical comorbidity: a randomized controlled non inferiority trial.
This research is looking into how well a low dose of a medication called amitriptyline works compared to a type of talking therapy called Cognitive Behavioural Therapy (CBT). It's for adults who have ongoing trouble sleeping (insomnia) and also have other health conditions. The main goal is to find out if the medicine is just as effective as CBT at improving how severe their insomnia is after 12 weeks. Researchers will also check how well people sleep, how they feel during the day (like tiredness or mood), and any side effects. This study is in the later stages of testing (Phase III and Phase IV).
At a glance
What is this study about?
This study is called the 'Efficacy of low dose amitriptyline vs. cognitive behavioural therapy for chronic insomnia and medical comorbidity: a randomized controlled non inferiority trial.' That's a bit of a mouthful, so let's break it down.
First, 'efficacy' means how well something works. We're looking at two different approaches for people who have long-lasting trouble sleeping, known as chronic insomnia, and also have other health problems. One approach uses a very small dose of a medicine called amitriptyline, which comes as a coated pill. The other approach is Cognitive Behavioural Therapy (CBT), which is a type of talking therapy that helps you change unhelpful thoughts and behaviours related to sleep.
The researchers want to see if the low-dose amitriptyline works just as well as CBT in helping people with their insomnia. This is called a 'non-inferiority' trial, meaning they want to show the new treatment isn't significantly worse than an existing one. They will measure how much a person's sleep problems have improved after 12 weeks using a special questionnaire. They'll also look at other things like how well people sleep each night, how they feel during the day (such as tiredness or mood), and any side effects people might have. Understanding which treatment is best, or if they are equally good, can help doctors and patients make better choices for managing insomnia.
Key takeaways
- Compares a low-dose medicine (amitriptyline) with talking therapy (CBT) for long-term sleep problems.
- For adults who have ongoing insomnia and other health conditions.
- Aims to see if the medicine works just as well as CBT to improve sleep.
- Involves regular assessments and questionnaires over a 12-week period.
- You will be randomly assigned to one of the treatments, not allowed to choose.
- It's important to discuss any potential benefits or risks with your doctor.
Who may be eligible?
To be able to take part in this study, you need to be an adult, aged 18 or over. This study is open to everyone, whether you are male or female.
The most important thing is that you must have ongoing trouble sleeping, also known as chronic insomnia, and other health conditions. The researchers will need to check your medical history to make sure you fit all the specific requirements for the study.
It's important to understand that not everyone with insomnia will be suitable. Doctors involved in the study will review your situation carefully to ensure the study is right for you and you meet all the necessary criteria.
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 trouble sleeping (insomnia) for a long time?
- Do you also have other health conditions?
- Are you able to attend regular appointments and complete questionnaires?
- Are you willing to be randomly assigned to either medication or talking therapy?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit to make sure you're suitable. Once enrolled, you would be randomly assigned to either receive the low-dose amitriptyline tablets or take part in cognitive behavioural therapy (CBT) sessions. This means you wouldn't get to choose which treatment you receive; it's decided by chance, like flipping a coin.
Over 12 weeks, you would be regularly assessed to track your sleep patterns and how you're feeling. This might involve filling out questionnaires about your sleep and daytime functioning, and keeping a sleep diary. The research team would also monitor for any side effects or how well you're sticking to your treatment. After the main 12-week treatment period, there would likely be follow-up assessments to see how you're doing. The total duration of your involvement could extend beyond the 12 weeks of active treatment for follow-up.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is chronic insomnia?
Chronic insomnia means you have trouble falling or staying asleep most nights for a long time, usually three months or more.
What is cognitive behavioural therapy (CBT)?
CBT is a type of talking therapy that helps you change unhelpful thoughts and behaviours that can affect your sleep.
What is amitriptyline?
Amitriptyline is a medicine often used at low doses to help with sleep and pain. In this study, it's a very low dose.
Will I get to choose my treatment?
No, you'll be randomly assigned to either receive the medication or the talking therapy. It's like drawing lots.
How long will I be in the study?
The main part of the treatment lasts 12 weeks, but your full involvement, including follow-up, might be longer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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