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MELODY Trial - Adjunctive MELatOnin or digital cognitive behavioural therapy for insomnia to restore sleep and circadian rhythms and to improve major Depression in Young adults: A randomised, placebo-controlled, double-blinded trial

The MELODY trial is a randomised clinical trial investigating the use of melatonin, placebo or an online digital cognitive-behavioural therapy program for insomnia (dCBT-I) over a 12-week intervention period.

Participants will complete questionnaires and assessments at enrolment, baseline, Weeks 4, 8, 12 and at follow-up (26 weeks) to track any changes to their mental health or sleep, in addition to fortnightly safety checks.

Participants will be reimbursed $150 in total for full participation and given a summary of their sleep information at follow-up.Ìý

Willing and eligible participants may also take part in overnight sleep studies before and after intervention (total of 2 nights in lab, 4 nights at home) for an additional $200 reimbursement for full participation. These participants will also be given more detailed reports into their sleep.

Eligibility

The study is open to people aged 18-30 with a diagnosed mood disorder (Anxiety, Depression, Bipolar-2 etc.), with some form of disturbed sleep (including insomnia, hypersomnia and delayed, irregular or fragmented sleep).

Exclusion criteria include diagnoses of bipolar 2 or psychosis, sleep apnoea, and other various medical conditions, current use of melatonin, warfarin or modafinil, and regular night shift work. A more detailed list of exclusion criteria will be discussed with participants during screening and enrolment.

How to participate

If you are interested in assisting with this important and exciting area of research, please go to to complete pre-screening and learn more about the MELODY trial.

If you have any questions, feel free to email melody.trial@sydney.edu.au or call 02 9351 9889.Ìý

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Ethics committee approval number:ÌýX23-0450 (Please note RESTORE is the previous name of this study)Ìý