Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000985886
Ethics application status
Approved
Date submitted
7/09/2012
Date registered
13/09/2012
Date last updated
8/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
A randomised controlled trial to evaluate whether a proven internet-delivered Cognitive Behavioural Therapy (CBT) treatment program for insomnia can improve the outcomes of standard treatment of depression in men.
Secondary ID [1] 281212 0
Nil
Universal Trial Number (UTN)
U1111-1133-7321
Trial acronym
SOMNA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 287127 0
Anxiety 287182 0
Insomnia 287183 0
Condition category
Condition code
Mental Health 287453 287453 0 0
Depression
Mental Health 287454 287454 0 0
Anxiety
Mental Health 287455 287455 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 285446 0
Treatment: Other
Intervention code [2] 285680 0
Behaviour
Comparator / control treatment
Participants assigned to the adjunctive control treatment will interact with the specially designed internet-based attention-control program comprising credible, but ineffective, sleep health information. Participants in this treatment arm will be free to use the program at their discretion over the nine week period.

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.
Control group
Active

Outcomes
Primary outcome [1] 287718 0
The change in the severity of self reported depressive symptoms, as measured using the Centre for Epidemiological Studies Depression scale (CES-D) between baseline and week 12.
Timepoint [1] 287718 0
Timepoints where assessments will be made will be at baseline, weeks 4, 8 and 12.
Primary outcome [2] 287798 0
The change in the severity of clinician rated depressive symtpoms as measured using the Hamilton Rating Depression Scale (HAM-D) between baseline and week 12.
Timepoint [2] 287798 0
Timepoints where assessment will be made will be at baseline and week 12.
Secondary outcome [1] 298814 0
The change in the severity of anxiety symptoms, as measured using the anxiety scale of the State Trait Personallity Inventory between baseline and week 12.
Timepoint [1] 298814 0
Timepoints where assessment will be made will be at baseline, week 12.
Secondary outcome [2] 298815 0
A change in the severity of insomnia symptoms, as measured using the Insomnia Severity Index rating scale between baseline and week 12.
Timepoint [2] 298815 0
Timepoints where assessment will be made will be at baseline, weeks 4, 8 and 12.

Eligibility
Key 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).
Minimum age
50 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The trial will recruit men aged 50+ with current clinically significant depressive and insomnia symptoms from the BMRI Clinical Centre, local secondary and primary care providers, and potentially high yield community advertising (for example, Centrelink) and local newspapers. Participants will be automatically randomised upon completion of the online consent, eligibility screening, and baseline assessment phase. Allocation concealment will be achieved using a customised randomisation schedule. The fully itemised procedure allows for full replication and can accommodate stratification and specification of block sizes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised at the time of baseline assessment using a randomly generated number sequence allocated by a blinded researcher not involved in trial data gathering, assessments or treatment. Randomisation will be undertaken using permuted blocks and stratified by depressive symptom severity with strata defined by HAM-D scores of < 17 or >= 17.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The intervention is internet based.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/02/2013
Actual
20/03/2013
Date of last participant enrolment
Anticipated
5/12/2014
Actual
5/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
87
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285842 0
Charities/Societies/Foundations
Name [1] 285842 0
beyondblue: the national depression and anxiety initiative
Country [1] 285842 0
Australia
Funding source category [2] 285843 0
Charities/Societies/Foundations
Name [2] 285843 0
The Movember Foundation
Country [2] 285843 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Brain and Mind Research Institute
100 Mallet St
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 284810 0
None
Name [1] 284810 0
Address [1] 284810 0
Country [1] 284810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287863 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 287863 0
Ethics committee country [1] 287863 0
Australia
Date submitted for ethics approval [1] 287863 0
14/05/2012
Approval date [1] 287863 0
27/06/2012
Ethics approval number [1] 287863 0
06-2012/14938

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34553 0
Prof Nicholas Glozier
Address 34553 0
Brain and Mind Research Institute 100 Mallett St Camperdown NSW 2050
Country 34553 0
Australia
Phone 34553 0
+61 2 9351 0536
Fax 34553 0
Email 34553 0
[email protected]
Contact person for public queries
Name 17800 0
Amelia English
Address 17800 0
Brain and Mind Research Institute
100 Mallett St
Camperdown NSW 2050
Country 17800 0
Australia
Phone 17800 0
+61291144213
Fax 17800 0
Email 17800 0
[email protected]
Contact person for scientific queries
Name 8728 0
Professor Nicholas Glozier
Address 8728 0
Brain and Mind Research Institute
100 Mallett St
Camperdown NSW 2050
Country 8728 0
Australia
Phone 8728 0
+61 2 9351 0536
Fax 8728 0
Email 8728 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe 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.2015https://dx.doi.org/10.1186/s12888-015-0397-x
EmbaseAdjunctive Internet-delivered cognitive behavioural therapy for insomnia in men with depression: A randomised controlled trial.2019https://dx.doi.org/10.1177/0004867418797432
N.B. These documents automatically identified may not have been verified by the study sponsor.