SOMNA

Portrait photograph of an older man who looks like he has trouble sleeping

The SOMNA (Sleep Or Mood Novel Adjunctive therapy) Research Study is for men aged 50 years and over who are experiencing symptoms of depression and insomnia.

This study program will offer eligible participants free psychiatric assessment and an individual care plan, along with access to one of two internet programs which each focus on sleep problems and insomnia.

The aim of the study is to evaluate whether the internet programs are effective in improving sleep and mood problems.

If you are interested in joining the SOMNA study, please complete our interest and consent form.

Clinical Study Status

Recruiting

On this page

Study description

The aim of the study is to evaluate whether the internet programs are effective in improving sleep and mood problems.

Although we have some effective treatments for depression, sleep problems can often make treatment more difficult, and can even remain after treatment and become long lasting.

We are trying to find out whether we can provide more effective treatment for mood problems by adding an internet-based treatment for sleep problems to care provided by our psychiatrists and psychologists.

We do this by asking people to do one of two internet programs, each lasting nine weeks and both focusing on sleep problems and insomnia. We are then interested in finding out which of these two programs is more helpful to individuals with depression and sleep problems.


What does participation involve?

We invite you to participate in a 14-week treatment program assessing and treating your mood, health and memory by a team of experienced doctors, psychologists and nurses.

During this program we will be undertaking a clinical trial where we will evaluate the effectiveness of an internet based program for sleep problems.

In order to participate, you will need to:

  • Attend the Brain and Mind Research Institute, Camperdown for FREE psychiatric assessment and individualised treatment plan
  • Neuropsychological assessment
  • Engagement with one of two internet programs which each focus on sleep problems and insomnia
  • Fill out a survey before and after participation
  • Complete an online sleep diary
  • Wear an actigraphy watch for two weeks
  • Attend for assessment and treatment at least 4 times over the course of 14 weeks

The SOMNA Research Study will span a 14-week period during which time you will have your mood and sleep problems assessed and managed at our clinic at the BMRI in Camperdown, for free, with a final online follow-up assessment then conducted at six months.

There are several components to this study:

Initial Information and Eligibility Screening

1. Fill out the interest and consent form on this website, and complete the initial eligibility screening questions.

2. Our research staff will then determine if you meet initial eligibility criteria. If you meet initial eligibility criteria, we will contact you by phone to ask you a few more questions about your sleep, health, and history to confirm your eligibility.

3. During the phone interview, we will explain the study and discuss the criteria for enrollment. We will have time to answer any questions or concerns you may have during the phone call.

4. If you are eligible after the phone interview is complete, we will invite you to come into the BMRI for a comprehensive medical assessment and an assessment of your thinking and memory.

Baseline Assessments

5. When you first come to the BMRI you will be seen by a number of people:

a. A researcher who will go through the treatments and assessments with you and who you can ask more questions. You will then need to sign a consent form regarding this study.

b. A doctor for a medical assessment and with whom you discuss your personal treatment plan. The nature of the medical assessment will involve asking you some questions about your medical and mental health. The assessment will take approximately 90 minutes.

c. A psychologist will assess your ‘cognition’ (thinking and memory), including your concentration, memory and problem-solving. This assessment will take approximately 30 minutes.

6. When you come to the BMRI, we also ask that you complete an online health survey which will take approximately 60 minutes to complete. We will provide you with an ‘actigraphy’ watch which you wear on your wrist that records movement and your sleeping patterns over a two week period. During this time we will also ask you to complete an online sleep diary each day for a two week period. This is expected to take a few minutes of your time each day.

Treatment Review and Commencement of Internet Programs

7. After two weeks you will return to the clinic at the BMRI for a first review of your treatment by one of the clinicians. You will also be returning the actigraphy watch you were given two weeks beforehand, that you have been wearing.

8. You will then start the sleep treatment program over the internet, which runs for nine weeks.

9. Over these nine weeks you will have your treatment for your mood monitored by the team with appointments at the BMRI as necessary.

Follow-up Assessments

10. After 12 weeks, you will have an appointment with the doctor who will repeat some of the assessments from your first appointment and discuss appropriate next steps for your care. You will then be asked to complete another online health survey and two weeks of sleep diaries, and to wear an actigraphy watch for another two weeks. You will then return to the BMRI for one last cognitive assessment (as in your first appointment), and also to return the actigraphy watch. Reimbursement for some travel costs to and from the Brain & Mind Research Institute will be available.

11. After six months, we will ask that you complete a final online health survey and two weeks of sleep diaries so we can track your progress.


How much time will the study take?

This study will be conducted over a total of 14-weeks, with a final online follow-up assessment then conducted at six months. Within this time frame, you need to be able to come in for assessment and treatment at the BMRI at least three times.

As well as attending the Brain & Mind Research Institute, there will be three fortnight-long periods over the duration of the study whereby you will have to complete a sleep diary on a daily basis (which should take a few minutes each day).

You will also be required to complete an online health survey on three occasions which will take approximately 60 minutes to complete.

Finally the internet sleep treatment program will involve up to an hour per week over nine weeks.


Can I withdraw from the study?

Being in this study is completely voluntary - you are not under any obligation to consent and - if you do consent - you can withdraw at any time without reason, and without affecting your relationship with the University of Sydney, or your treating clinician.

We will also continue to treat you for the study period and arrange follow up care afterwards as required.


Your right to privacy

All aspects of the study are strictly confidential. The trial information you give us will be held in a secure location and only the researchers involved in this study will have access to your data. Any information that is obtained in connection with this study and that can identify you will remain confidential and will be disclosed only with your permission.

Your clinical information will be known by your treating clinicians (doctor, psychologist or nurse) as it would be in any clinic and kept confidential under standard clinical procedures and security. This may be shared with other clinicians e.g. your GP only with your consent.


Benefits of participating

You may benefit from this study as you will receive treatment for depression, as well as sleep problems that you may have.

You will be given the chance to receive standard clinical care over 14-weeks aiming to improve your depressive and sleep symptoms.

The study offers comprehensive medical and neuropsychological assessments, free of charge, which some people may consider to be beneficial.


Questions or concerns

If you would like to know more at any stage, please feel free to contact the Study Manager on +61 2 9114 4002.

For any concerns or complaints about the conduct of a research study, please contact:

The Manager
Human Ethics Administration
University of Sydney
T +61 2 8627 8176
F +61 2 8627 8177
E


Information for referrers

The SOMNA (Sleep Or Mood Novel Adjunctive therapy) Research Study is a trial evaluating whether the addition of a computerised program targeting sleep problems can improve the outcomes of depression care in men aged over 50. Within this study patients receive free, psychiatrist initiated and supervised, personalised three month treatment plans for their mood and sleep problems. It is being conducted by the Brain & Mind Research Institute, University of Sydney, based at Camperdown. This trial will commence in October 2012 and recruitment will extend over 12 months. The study is funded by beyondblue: the national depression and anxiety initiative and the Movember Foundation.


Funding source(s)


About us

The SOMNA Research Study is being conducted by a team of doctor and psychologist researchers from a variety of institutions.

The study will be led by Professor Nicholas Glozier from the University of Sydney’s Brain and Mind Research Institute, and supported by a team including:

  • Trial Manager
  • Trial Doctors
  • Trial Nurse
  • Research Assistants


Other Chief Investigators include:

Professor Nick Glozier

Professor Nick Glozier is a consultant psychiatrist and epidemiologist who conducts work on diagnosis, measurement, assessment and treatment in mental health, comorbid disorders and disability. He is interested in a range of mental health and disability issues, particularly psychosocial and work related disability research, stress, stigma and discrimination. Nick also co-ordinates the Psychological and Addiction Medicine Programme for the 3rd year Graduate Medical Program of the University of Sydney, co-ordinates two units of the Master of Science in Brain & Mind Sciences and teaches a range of medicine, pharmacy and public health courses.

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Associate Professor Sharon Naismith

Associate Professor Sharon Naismith is the Director of the Clinical Research Unit at the Brain & Mind Research Institute. She is a Clinical Neuropsychologist who also Heads the Healthy Brain Ageing Clinic. Sharon is interested in late-life neurodegenerative and neuropsychiatric disorders, particularly Parkinson's Disease, Mild Cognitive Impairment and late-life depression. Sharon’s work incorporates multiple facets of these disorders including sleep-wake disturbance, cognition, neuro-imaging and genetics. Sharon is also the Postgraduate Coordinator for the Master of Science in Brain & Mind Sciences and provides supervision to postgraduate research and clinical students.

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Professor Ian Hickie

Professor Ian Hickie AM is the Executive Director of the Brain & Mind Research Institute at the University of Sydney. He was one of the first round of National Health and Medical Research Council Australian Fellows (from 2008 until 2013), having been recognised for excellence in Australian Medical Research including the early detection and treatment of depressive disorders. From 2000–2003 Ian was the inaugural CEO of beyondblue: the national depression initiative and from 2003-2006 served as the organisation’s Clinical Advisor. In July 2008 Ian was appointed to the Federal Health Minister's new National Advisory Council on Mental Health and from 2012, he is also one of Australia's first National Mental Health Commissioners. Ian’s research, clinical and health services development work focuses on expansion of population-based mental health research and development of international mental health strategies. He has published over 320 peer-reviewed journal articles, 20 book chapters and 30 educational materials.

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Professor Helen Christensen

Professor Helen Christensen is currently Professor of Mental Health at the University of New South Wales, a National Health and Medical Research Council Senior Principal Research Fellow, a member of the Academy of Social Sciences, Australia and the President of the Australasian Society for Psychiatric Research. As Executive Director of the Black Dog Institute, Helen aims to facilitate the Institute’s goal to lower mood disorders in the community by providing the highest quality information, assessment, clinical and prevention services. Helen is recognised as an international leader in epidemiology, public mental health and e-health. She has over 300 research publications, and has produced a number of e-mental health web applications, including MoodGYM, which is used by over 450,000 individuals globally as a means of lowering depression. She has received over 8 state and national awards for her work in providing services directly to consumers through the web.

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Professor Kathleen Griffiths

Professor Kathleen Griffiths is Director of the Centre for Mental Health Research at the Australian National University. She is a Senior Fellow at the Centre for Mental Health Research and is also Director of the Depression and Anxiety Consumer Research Unit and e-hub: e-mental Health Research and Development Group. Kathy's research interests include consumer informatics, the development and evaluation of Internet psycho-educational, early intervention and preventive interventions, the evaluation of online self help communities, and the use of the Internet in reducing stigma. She also leads a number of consumer focused projects including consumer priorities for research, consumer reports of treatment effectiveness, consumer information needs and the evaluation of stigma associated with depression. Kathy has co-developed several mental health websites including BluePages,MoodGYM and e-couch, and is the author of approximately 150 books, chapters and academic articles.

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Associate Professor Lee Ritterband

Dr Lee Ritterband is an Associate Professor at the University of Virginia Health System and Director of the Behavioural Health and Technology program area. He has been a Principal or Co-Investigator on large research projects funded by the National Institute of Mental Health; the National Institute for Childhood Health and Human Development; the National Institute for Diabetes, Digestive and Kidney Diseases; the National Institute of Drug and Alcohol; the National Institute on Alcohol Abuse and Alcoholism; the American Diabetes Association; and the Virginia Department of Criminal Justice Services. In 2004, he co-founded the International Society for Research on Internet Interventions which is the leading international organisation focused on Internet intervention research. He is on the editorial board of Health Psychology, and is well published in the scientific literature.

Lee also served as Principal Investigator of the first National Institute of Mental Healthgrant on which the intervention in this new trial is based as well as a pilot trial of this intervention with cancer survivors with insomnia.Lee specialises in the development and testing of behaviourally-based treatment programs delivered via the Web.He has given numerous talks nationally and internationally on the use of the Internet in psychological research and clinical practice.

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Assistant Professor Frances Thorndike

Dr Frances Thorndike is an Assistant Professor at the University of Virginia Health System in the Behavioural Health and Technology program area. Prior to her work at the University of Virginia, Frances collaborated with Dr. Brett Litz at Boston University on the DElivery of Self-TRraining and Education for Stressful Situations or DESTRESS trial that tested an Internet intervention to service members with PTSD from the attack on the Pentagon on 9-11 or the Iraq War. At the University of Virginia, Frances has been a co-investigator on multiple National Institutes of Health-funded studies utilising technology to increase access to treatment, including the prior insomnia Internet intervention studies. She is also a Co-Investigator on an NICHD Internet intervention for pediatric encopresis. Frances has published several papers in these areas, and given talks to both national and international audiences. Frances’ research interests include the development and evaluation of Internet interventions for various medical and behavioural health problems, including insomnia, post-traumatic stress, encopresis, and diabetes. She has been conducting research in the field of Internet interventions since 2002.


Links


Information about sleep and insomnia

What is insomnia?

Insomnia relates to difficulty initating or maintaining or non restorative sleep. It encompasses four main problems:

  • Difficulities falling asleep at bed time
  • Difficulties remaining asleep
  • Waking up too early and being unable to fall back to sleep
  • Unrefreshing sleep

What are the causes of insomnia?

  • The most common causes of insomnia include:
  • Medical conditions i.e. Pain, asthma, heart and hormonal disturbances can lead to insomnia
  • Prescribed medicines, drugs and alcohol: These can all disrupt sleep patterns
  • Age: Advancing age is a risk factor for insomnia. As people get older they sleep more lightly and wake more often taking longer to get back to sleep. See information about “How to sleep well as you age
  • Poor sleep habits
  • Life stressors and anxiety can also be a trigger for sleeping difficulties
  • Environmental causes like shift work, jet lag, pets, newborns.
  • Stress and anxiety and depression
Risk factors for insomnia
Physical Psychological Environmental
Genetic predisposition Obsessional cognitive style Jet lag
Increasing age Anxiety Shift work
Female Depression Household noise
Medical conditions, ie pain, asthma, heart problems Worry about the sleep problem itself Ambient light and termperature

How common is insomnia?

Insomnia is a common complaint. While occasional insomnia can affect us all, persistent problems sleeping can seriously impact quality of life, therefore it is important to seek help from a health professional should you be worried about your sleep patterns.

The World Health Organisation states that prevalence of short-term insomnia symptoms in the general population is approximately 30% to 50%. Persistent insomnia has a prevalence of 9% to 15%, and occurs more frequently in women, older adults, and patients with chronic medical and psychiatric disorders.

What are the effects of insomnia?

Insomnia can affect all aspects of our life including mood, work performance and physical health.
Common symptoms of insomnia include: daytime drowiness, fatigue and irritability as well as difficulty concentraing during the day

In a recent scientific article, sleep medicine researchers found that sleep loss may be a independent risk factor for becoming overweight and developing type II diabetes.

Consequences of insomnia
Physical Psychological Environmental
Overweight Poorer memory and concentration Increase incidence of accidents
Increase risk of diabetes Irritability Poorer work performance
Impaired immune function Depressed mood Relationship stress

Tips and hints for dealing with insomnia

  1. Practice good "sleep hygiene": Sleep hygeine refers to behaviours that promote a good night sleep. It can help to retrain your mind and create good habits that will help you sleep.
  2. Only go to bed when you are sleepy
  3. Avoid caffeinated drinks after midday
  4. expose yourself to sunlight early in the day
  5. exercise regularly, not to close to bed time
  6. get up at the same time every day, regardless of when you went to sleep
  7. avoid excessive alcohol consumption
  8. establish a relaxing bedtime routine i.e. Warm bath, reading a book
  9. make your bedroom a no work zone, this will help your brain recognise that it’s time for sleep
  10. If you can’t fall asleep after 30 minutes, get out of bed, do something relaxing and only return to bed when sleepy
  11. Try not to obsess about not sleeping

    prepare your brain for sleep: make sure you room is dark, cool and quiet.
  12. Avoid napping

Read this Huffington post article "8 habits of extremely well-rested people"