EXPLANATORY STATEMENT

Project ID: 26800
Project title: Herbal Supplement Treatment for Insomnia 

Chief Investigators: Dr Melinda Jackson
School of Psychological Sciences
Phone: 99050206
Email: melinda.jackson@monash.edu

Research Assistant: Ms Flora Le
School of Psychological Sciences
Email: base.mindfulsleep@monash.edu


You are invited to take part in this study.  Please read this Explanatory Statement in full before deciding whether or not to participate in this research. If you would like further information regarding any aspect of this project, you are encouraged to contact the researchers via the phone numbers or email addresses listed above.

What are the purposes of the study?
Insomnia is one of the most prevalent sleep disorders, and 30% of people in the community experience some symptoms of insomnia at any given time. The symptoms include difficulties getting to sleep, difficulties staying asleep, or early-morning awakenings with an inability to return to sleep. Insomnia may also be associated with problems with memory and attention, and increased feelings of depression, anxiety and stress. Whilst insomnia can be treated effectively with medication and behavioural therapy, it is important to identify and evaluate alternative insomnia interventions, such as supplements, for people with insomnia.

This study aims to investigate the effectiveness of an herbal supplement for improving sleep measures and reducing insomnia symptoms in people with difficulties getting to sleep or difficulties staying asleep, compared to a placebo. The study is funded by a grant from the Department of Industry, Innovation and Science, with Melrose Health

What does the research involve?
Screening 
If we think this study is right for you, you will be invited to a 30-minute screening session via Zoom or the phone. In this session, we will introduce to the study, answer any questions you may have, and assess your eligibility. You will be asked to complete a set of online questionnaires that ask about your sleep. If you are eligible, you will be invited to progress to the next phase of our 7-week study.

Run-in Phase (2 Weeks)
In this period, we would like to learn more about your habitual sleep. You will be asked to wear an actigraphy monitor (a watch-like device that records your sleep-wake behaviours) daily and report your sleep, mood, and arousal during bedtime using a daily diary each morning. The study materials, including the actigraphy watch and sleep diary will be posted to you. The surveys will take approximately 10 to complete. At the end of this phase, you will be asked to return the study materials to us via post.

Treatment (4 Weeks)
This is a triple-blind randomised controlled research project. Sometimes we do not know which treatment is best for treating a condition. To find out we need to compare different treatments. We put people into groups and give each group a different treatment. The results are then compared to see if one is better. To try to make sure the groups are the same, each participant is allocated into a group by chance (random). You will not get to choose which group you are allocated to. Neither you, the research staff nor the outcome assessor will know which treatment you are receiving. However, in certain circumstances, the researcher can find out which treatment you are receiving.

In the treatment phase, you will be allocated into 1 of 2 groups. The treatment involves a combination of herbal products thought to help with sleep. A placebo is a medication with no active ingredients without any medical benefit. It looks like the real medication but is not.

Each group will receive either the study medication or placebo for 4 weeks. You will not get to choose which group you are allocated to. You will be asked to take the study medication every night before bed. Study medication is in the form of liquid to be taken orally. You will take 10 ml each night, about 30 minutes before bed. During the last two weeks of the treatment period, you will be asked to wear the actigraphy watch and complete sleep diaries.
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Online questionnaires
You will be asked to complete some online questionnaires throughout the study so that we can understand whether the treatment helps. The link to these questionnaires will be e-mailed to you. They will ask about your sleep, mood and arousal during bedtime.

You will complete a survey:
  • Before starting the study
  • Beginning of treatment period
  • Mid treatment period
  • At the end of treatment period

How much time will this study take across the entire 7 weeks?
  • Initial screening and baseline assessment = ~ 1.5 hours
  • Beginning of treatment assessment = ~ 1 hour
  • Mid treatment period = ~ 5 mins
  • End of treatment assessment = ~ 1 hour

Why were you chosen for this research?
You were chosen to participate because you have indicated complaints of sleep disturbance at least three nights a week, are fluent in English, and are able and willing to accept and comply with the study protocols. 

Consenting to participate in the project and withdrawing from the research
Taking part in this project is voluntary. If you do not wish to take part, you do not have to. To consent to participate, please complete and digitally sign the consent form.

You have the right to:

  • withdraw from further participation at any stage

  • request to withdraw and destroy any unprocessed data

  • seek clinical treatment for your sleep if you do not wish to participate (see contacts below).


If you decide to withdraw from the project, please notify the research team.

 

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