Research projects

A randomised controlled trial of the efficacy of adjunctive internet- based CBTi in treating depression and anxiety in older men

Movember Foundation logo

Proudly supported by The Movember Foundation.

Principal researcher

Associate Professor Nick Glozier1
Professor Helen Christensen2
Professor Kathleen Griffiths3
Associate Professor Sharon Naismith4

Institution

1 Central Clinical School & Brain & Mind Research Institute
2 Black Dog Institute
3 Australian National University
4 University of Sydney

Funding

$391,364 – This project is funded through donation from the Movember Foundation

Award type

National Priority Driven Research Program

Project completion year

2015

Project brief

Men with symptoms of depression and anxiety, particularly in the oldest and youngest age groups, seek help far less than women for a given threshold or condition. Depression can be treated in this age group, with similar effects seen from medication and psychotherapy interventions, and recent studies have demonstrated that collaborative approaches can be more successful. Multimodal approaches selecting participants likely to do less well with standard interventions can be an important element, particularly if accessible and compatible.

Insomnia symptoms are commonly recognised and a major source of help-seeking in primary care with less of a gender difference.  Insomnia is seen as a less stigmatising disorder than depression. Recently, an accessible internet-based intervention for insomnia has been shown to work effectively in both genders and lead to a significant reduction in depressive and anxious symptoms compared to wait list controls.

This project will test this intervention in a pilot randomised controlled trial (RCT) evaluating adjunctive insomnia treatment in older men with depression and insomnia symptoms. 

It is a pilot randomised controlled trial of 80 men aged 50+ who will be recruited from the Brain & Mind Research Institute (BMRI) clinics, primary care, and male focussed community settings and invited to undertake internet-based screening. Those reporting distressing levels of depression and insomnia symptoms will be invited to a clinical assessment and information session, and informed consent will be gained. The blinded clinician will use beyondblue guideline approaches to managing the depressive anxious symptoms in collaboration with the GP and/or referral on for psychotherapy.

Participants will be randomised to a nine-week, internet -based CBTi program treating insomnia (SHUTi) or a nine-week, known credible but ineffective health promotion control program (Healthwatch). Sleep, mental health, cognitive function and usage parameters will be assessed at baseline, post intervention and six months either within the program or by blinded researchers. A focus will be on the requirements for support during this intervention, process and adherence evaluation of the intervention.

Anticipated practical outcomes, community benefits

The outcomes of this trial will be readily applicable for translation into health care and include:

  • the demonstration of the effect (or not) of a scalable adjunctive insomnia based intervention for older men with depression and insomnia problems
  • the evaluation of the impact of this adjunctive treatment upon anxiety, sleep parameters, cognition and disability.
  • identification of processes and or specific target groups that may require refining of the program.
  • adherence and persistence issues with the program with respect to the target group.
  • identification of any harmful effects of such an adjunct.

By utilising the beyondblue guidelines for all participants within the control group, the impact of treatment of older men under these guidelines will also be evaluated.

Finally, the study provides the required information to determine whether and how to conduct a definitive RCT. Many interventions, particularly if they have minimal likelihood of harm, were often adopted prior to definitive RCTs, e.g. certain alcohol reduction and out benefit/harm approach will inform this recommendation.

Stay in touch with us

Sign up below for regular emails filled with information, advice and support for you or your loved ones.


All done! You should’ve received a confirmation email, so please check when you’re finished here and click the link in the email. If you can’t see it, we might be in your junk mail.

Subscribe failed. Please try later or contact us.