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The Sleep Or Mood Novel Adjunctive therapy (SOMNA) trial: a study protocol for a randomised controlled trial evaluating an internet-delivered cognitive behavioural therapy program for insomnia on outcomes of standard treatment for depression in men.

Cockayne NL, Christensen HM, Griffiths KM, Naismith SL, Hickie IB, Thorndike FP, Ritterband LM, Glozier NS - BMC Psychiatry (2015)

Bottom Line: Insomnia is a significant risk factor for depression onset, can result in more disabling depressive illness, and is a common residual symptom following treatment cessation that can increase the risk of relapse.The study will be conducted in urban New South Wales, Australia, where 80 participants from primary and secondary care and direct from the local community will be recruited.The primary outcome is change in the severity of depressive symptoms from baseline to week 12.

View Article: PubMed Central - PubMed

Affiliation: Healthy Brain Ageing Program, Brain and Mind Research Institute, University of Sydney, 94 Mallett Street, Camperdown, NSW, 2050, Australia. nicole.cockayne@sydney.edu.au.

ABSTRACT

Background: Insomnia is a significant risk factor for depression onset, can result in more disabling depressive illness, and is a common residual symptom following treatment cessation that can increase the risk of relapse. Internet-based cognitive behavioural therapy for insomnia has demonstrated efficacy and acceptability to men who are less likely than women to seek help in standard care. We aim to evaluate whether internet delivered cognitive behavioural therapy for insomnia as an adjunct to a standard depression therapeutic plan can lead to improved mood outcomes.

Methods/design: Male participants aged 50 years or more, meeting Diagnostic and Statistical Manual of Mental Disorders criteria for current Major Depressive Episode and/or Dysthymia and self-reported insomnia symptoms, will be screened to participate in a single-centre double-blind randomised controlled trial with two parallel groups involving adjunctive internet-delivered cognitive behavioural therapy for insomnia and an internet-based control program. The trial will consist of a nine-week insomnia intervention period with a six-month follow-up period. During the insomnia intervention period participants will have their depression management coordinated by a psychiatrist using standard guideline-based depression treatments. The study will be conducted in urban New South Wales, Australia, where 80 participants from primary and secondary care and direct from the local community will be recruited. The primary outcome is change in the severity of depressive symptoms from baseline to week 12.

Discussion: This study will provide evidence on whether a widely accessible, evidence-based, internet-delivered cognitive behavioural therapy for insomnia intervention can lead to greater improvements than standard treatment for depression alone, in a group who traditionally do not readily access psychotherapy. The study is designed to establish effect size, feasibility and processes associated with implementing e-health solutions alongside standard clinical care, to warrant undertaking a larger more definitive clinical trial.

Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12612000985886 .

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Related in: MedlinePlus

Proposed flow of participants.
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Fig1: Proposed flow of participants.

Mentions: The study is a single-centre double-blind randomised controlled trial (RCT) with two parallel groups involving an internet-delivered CBTi intervention and an insomnia education control condition. The trial consists of a nine-week insomnia intervention period and six-month follow-up period. The intervention will be delivered as an adjunct to standard guideline-based treatment for depression. As such, during the intervention period, participants in both arms will have their depression assessed, and the treatment managed, by a psychiatrist in accordance with clinical practice guidelines [23,24]. At trial entry, and after randomisation, participants will complete baseline clinical, sleep and self-report measures over two-weeks. They will then commence their internet-delivered CBTi program / web-based insomnia education (control) and continue with it over the subsequent nine-weeks. Participants will be contacted by telephone at Week 4 and Week 8 for trial monitoring purposes. At Week 12, they will commence the post-intervention assessment and will repeat the clinical, sleep and self-report measures collected at baseline. Throughout this period they will have face-to-face sessions with the psychiatrist, their General Practitioner (GP) and other health professionals, as clinically required, to manage their depression. Six months after completion of the post-intervention assessment, participants will complete the self-report, psychological and sleep measures. As such there will be three principal occasions of measurement over the full study period: baseline, post-intervention, and 6-months post-intervention, and the primary endpoint will be a reduction in depressive symptoms at post-intervention (week 12). The total trial period will be nine months. The trial has been registered on the Australian and New Zealand Clinical Trial Registry (ACTRN12612000985886). The trial design is shown graphically in FigureĀ 1.Figure 1


The Sleep Or Mood Novel Adjunctive therapy (SOMNA) trial: a study protocol for a randomised controlled trial evaluating an internet-delivered cognitive behavioural therapy program for insomnia on outcomes of standard treatment for depression in men.

Cockayne NL, Christensen HM, Griffiths KM, Naismith SL, Hickie IB, Thorndike FP, Ritterband LM, Glozier NS - BMC Psychiatry (2015)

Proposed flow of participants.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4321324&req=5

Fig1: Proposed flow of participants.
Mentions: The study is a single-centre double-blind randomised controlled trial (RCT) with two parallel groups involving an internet-delivered CBTi intervention and an insomnia education control condition. The trial consists of a nine-week insomnia intervention period and six-month follow-up period. The intervention will be delivered as an adjunct to standard guideline-based treatment for depression. As such, during the intervention period, participants in both arms will have their depression assessed, and the treatment managed, by a psychiatrist in accordance with clinical practice guidelines [23,24]. At trial entry, and after randomisation, participants will complete baseline clinical, sleep and self-report measures over two-weeks. They will then commence their internet-delivered CBTi program / web-based insomnia education (control) and continue with it over the subsequent nine-weeks. Participants will be contacted by telephone at Week 4 and Week 8 for trial monitoring purposes. At Week 12, they will commence the post-intervention assessment and will repeat the clinical, sleep and self-report measures collected at baseline. Throughout this period they will have face-to-face sessions with the psychiatrist, their General Practitioner (GP) and other health professionals, as clinically required, to manage their depression. Six months after completion of the post-intervention assessment, participants will complete the self-report, psychological and sleep measures. As such there will be three principal occasions of measurement over the full study period: baseline, post-intervention, and 6-months post-intervention, and the primary endpoint will be a reduction in depressive symptoms at post-intervention (week 12). The total trial period will be nine months. The trial has been registered on the Australian and New Zealand Clinical Trial Registry (ACTRN12612000985886). The trial design is shown graphically in FigureĀ 1.Figure 1

Bottom Line: Insomnia is a significant risk factor for depression onset, can result in more disabling depressive illness, and is a common residual symptom following treatment cessation that can increase the risk of relapse.The study will be conducted in urban New South Wales, Australia, where 80 participants from primary and secondary care and direct from the local community will be recruited.The primary outcome is change in the severity of depressive symptoms from baseline to week 12.

View Article: PubMed Central - PubMed

Affiliation: Healthy Brain Ageing Program, Brain and Mind Research Institute, University of Sydney, 94 Mallett Street, Camperdown, NSW, 2050, Australia. nicole.cockayne@sydney.edu.au.

ABSTRACT

Background: Insomnia is a significant risk factor for depression onset, can result in more disabling depressive illness, and is a common residual symptom following treatment cessation that can increase the risk of relapse. Internet-based cognitive behavioural therapy for insomnia has demonstrated efficacy and acceptability to men who are less likely than women to seek help in standard care. We aim to evaluate whether internet delivered cognitive behavioural therapy for insomnia as an adjunct to a standard depression therapeutic plan can lead to improved mood outcomes.

Methods/design: Male participants aged 50 years or more, meeting Diagnostic and Statistical Manual of Mental Disorders criteria for current Major Depressive Episode and/or Dysthymia and self-reported insomnia symptoms, will be screened to participate in a single-centre double-blind randomised controlled trial with two parallel groups involving adjunctive internet-delivered cognitive behavioural therapy for insomnia and an internet-based control program. The trial will consist of a nine-week insomnia intervention period with a six-month follow-up period. During the insomnia intervention period participants will have their depression management coordinated by a psychiatrist using standard guideline-based depression treatments. The study will be conducted in urban New South Wales, Australia, where 80 participants from primary and secondary care and direct from the local community will be recruited. The primary outcome is change in the severity of depressive symptoms from baseline to week 12.

Discussion: This study will provide evidence on whether a widely accessible, evidence-based, internet-delivered cognitive behavioural therapy for insomnia intervention can lead to greater improvements than standard treatment for depression alone, in a group who traditionally do not readily access psychotherapy. The study is designed to establish effect size, feasibility and processes associated with implementing e-health solutions alongside standard clinical care, to warrant undertaking a larger more definitive clinical trial.

Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12612000985886 .

Show MeSH
Related in: MedlinePlus