None listed
Conditions
Brief summary
Insomnia and Depression share many common features such as low energy, fatigue, poor concentration and sleep difficulties. Insomnia is not just a symptom of depression however, and this is why insomnia symptoms remain nearly 50% of the time through antidepressant treatment. The objective of the current research is therefore to treat the sleep disturbances in individuals with depression and insomnia (whose symptoms have not remitted through at least 6-weeks of antidepressant treatment) with 4 sessions of CBT-I. The aims are to improve the participant's quality of sleep and reduce both their insomnia and depression severity. Our primary hypotheses are that participants receiving CBT-I will have significantly improved sleep quality and significantly reduced insomnia and depression severity compared to an information only control (IOC) group after the 8 weeks of treatment and at the 3-month follow-up session.
Interventions
Cognitive behavioural therapy for insomnia(CBT-I): 4 one-on-one face-to-face sessions of CBT-I are conducted with a psychologist across 8 weeks of treatment (one 50 minute session every two weeks). Session one consists of sleep education and sleep hygiene recommendations as well as an introduction to relaxation techniques. Session two focuses on the importance of sleep scheduling and discusses the rationale and instructions for both stimulus control and sleep restriction. It also introduces prog
Cognitive behavioural therapy for insomnia(CBT-I): 4 one-on-one face-to-face sessions of CBT-I are conducted with a psychologist across 8 weeks of treatment (one 50 minute session every two weeks). Session one consists of sleep education and sleep hygiene recommendations as well as an introduction to relaxation techniques. Session two focuses on the importance of sleep scheduling and discusses the rationale and instructions for both stimulus control and sleep restriction. It also introduces progressive muscle relaxation. Session three looks to adjust the sleep schedule, overcome adherence issues and focuses on cognitive restructuring around unhelpful beliefs and attitudes about sleep. It also has an imagery relaxation exercise. The fourth and last session Assesses gains made across the treatment, looks at maintenance strategies and relapse prevention, and concludes with a mindfulness relaxation exercise. A 3 month-follow up is then conducted to monitor changes over time.
Sponsors
Associate Professor Shantha Rajaratnam
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Individuals with Major Depressive Disorder and chronic insomnia who have been prescribed with and have adhered to standard antidepressant (SSRI) treatment for at least 6 weeks.
Exclusion criteria
Participants must not take any medication for insomnia in the 14 days prior to the screening visit and are requested to not undertake any other ongoing types of treatment (including over-the-counter medications or herbs) or therapy (including alternative therapy) of claimed efficacy for depression or insomnia at any point in the study. Participants will be excluded if they have had electro-convulsive therapy (ECT) in the prior year and if they exhibit any current active suicidal potential or psychotic features. Diagnosis of seasonal affective disorder or major depressive disorder (MDD) with a seasonal pattern will be exclusionary. Participants must not have any other co-morbid psychiatric conditions, or any conditions incompatible with standard antidepressants (SSRIs). Participants will be excluded if they have a current diagnosis of any other primary sleep disorder or any uncontrolled medical conditions. Participants with inadequate English language fluency will also be excluded from the study.
Outcome results
None listed