SOMNA: Sleep Or Mood Novel Adjunctive therapy. The effectiveness of an adjunctive internet Cognitive Behavioural Therapy (CBT) intervention for insomnia in older men with depression.

Conditions

None listed

Brief summary

This study investigates the efficacy of an internet-based insomnia treatment program (SHUTi), compared to an internet delivered control program, as an adjunctive treatment to beyondblue guideline based treatment for reducing depressive symptom severity amongst men aged 50 and over with co-morbid depression and insomnia symptoms. Secondary aims are to determine whether adjunctive SHUTi improves insomnia and anxiety symptoms.

Charles Chan, Stacey West, Nick Glozier

Journal of Medical Internet Research2017-02-1032 citations

10.2196/jmir.5639

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.

2015-02-055 citations

10.1186/s12888-015-0397-x

Interventions

The intervention of interest for this study is the adjunctive internet based insomnia treatment program - Sleep Healthy Using the Internet (SHUTi). SHUTi is an efficacious e-health Cognitive Behavioural Therapy for Insomnia (CBTi), which consists of six modules delivered over nine weeks. These address sleep behaviours, sleep beliefs and sleep hygiene in a structured interactive format. Completion of the six modules involves up to an hour per week over nine weeks. All trial participants will a

The intervention of interest for this study is the adjunctive internet based insomnia treatment program - Sleep Healthy Using the Internet (SHUTi). SHUTi is an efficacious e-health Cognitive Behavioural Therapy for Insomnia (CBTi), which consists of six modules delivered over nine weeks. These address sleep behaviours, sleep beliefs and sleep hygiene in a structured interactive format. Completion of the six modules involves up to an hour per week over nine weeks. All trial participants will also have their depression managed over the three months of the trial by the psychiatric team using standard guideline based depression treatments.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

50 Years to 80 Years

Healthy volunteers

No

Inclusion criteria

All participants must meet the following inclusion criteria: (a) currently meet the criteria for at least minor depression (defined as screening positive (8+) on the Quick Inventory of Depression Symptomology (QIDS) and at clinical interview by having one of the two cardinal symptoms of Major Depressive Disorder (MDD) and at least two other symptoms of depression for two weeks or more (four symptoms minimum in total)); and (b) self report insomnia symptoms above the threshold (8+) Insomnia Severity Index (ISI).

Exclusion criteria

We will exclude participants if: (a) they have a history of psychosis, or hypo/manic episodes; (b) have a current substance dependence; (c) have a score of <24 on the Mini Mental State Examination; all as determined by the psychiatrist clinical interview; (d) are a rotating shift worker with overnight shifts or transmeridian travel >2 hours in the past month with inadequate time to readjust prior to trial commencement; (e) have all the criteria for Restless Legs Syndrome as defined using the RLS-12 at screening; (f) are at high risk for obstructive sleep apnea (OSA) as defined by the Berlin Questionnaire or have been treated for OSA.

Outcome results