Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000825651
Ethics application status
Approved
Date submitted
23/07/2014
Date registered
4/08/2014
Date last updated
22/10/2021
Date data sharing statement initially provided
22/10/2021
Date results provided
22/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Online Prevention Treatment Involving Medically Ill Seniors without Depression
Scientific title
In Older Adults with Multimorbidity, Does Internet-Delivered Cognitive Behaviour Therapy, Compared to No Treatment, Prevent Depression?
Secondary ID [1] 284567 0
Nil
Universal Trial Number (UTN)
U1111-1156-6080
Trial acronym
OPTIMISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 291841 0
Condition category
Condition code
Mental Health 292205 292205 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an 8 week internet-delivered cognitive behaviour therapy (i-cbt) program. The i-cbt has been developed as a treatment for depression and anxiety in older adults. The therapy involves 5 lessons released sequentially over 8 weeks. The therapy is clinician supported through brief contact via telephone or email each week (approximately 10 minutes). In addition to the core lessons there are homework activities and supplementary resources. Reminder emails to indicate the release of lessons are part of the protocol. Engagement in the program is monitored through clinician contact, tracking of lesson completion, observation of downloads of resources and observation of participant time spent online. The approximate time required to complete each lesson is 60 minutes. It is expected that participants will spend some additional time during the week engaging in the program through reading the lesson summaries, completing homework, practicing the skills and reading the supplementary resources.
Intervention code [1] 289339 0
Prevention
Intervention code [2] 289926 0
Behaviour
Comparator / control treatment
The control group receives no treatment.
Control group
Active

Outcomes
Primary outcome [1] 292074 0
Depression diagnostic status as measured by the Primary Care Evaluation of Mental Disorders – Mood Module (PRIME-MD)
Timepoint [1] 292074 0
Pre-treatment, 24 month post treatment and at any time within the 24 month post-treatment period that a participant's GDS score indicates depression is likely i.e. score is equal to or greater than 5.
Primary outcome [2] 292075 0
Severity of depression as measured by the Geriatric Depression Scale – Short Form (GDS-SF)
Timepoint [2] 292075 0
Pre-treatment, post-treatment, 6 months post treatment, 12 months post treatment and 24 months post treatment
Primary outcome [3] 292076 0
Severity of depression as measured by the Patient Health Questionnaire – 9 item
Timepoint [3] 292076 0
Pre-treatment, post-treatment, 6 months post treatment, 12 months post treatment and 24 months post treatment.
Secondary outcome [1] 308164 0
Severity of anxiety as measured by the Geriatric Anxiety Inventory
Timepoint [1] 308164 0
Pre-treatment, post-treatment, 6 months post treatment, 12 months post treatment and 24 months post treatment
Secondary outcome [2] 308165 0
Severity of anxiety as measured by the GAD-7
Timepoint [2] 308165 0
Pre-treatment and post-treatment
Secondary outcome [3] 308166 0
Quality of life as measured by The Satisfaction with Life Scale
Timepoint [3] 308166 0
Pre-treatment, post-treatment, 6 months post treatment, 12 months post treatment and 24 months post treatment
Secondary outcome [4] 308167 0
Disability as measured by the Sheehan Disability Scale
Timepoint [4] 308167 0
Pre-treatment, post-treatment, 6 months post treatment, 12 months post treatment and 24 months post treatment
Secondary outcome [5] 308168 0
Pain severity as measured by the Visual Analogue Scale (VAS).
Timepoint [5] 308168 0
Pre-treatment, post-treatment, 6 months post treatment, 12 months post treatment and 24 months post treatment
Secondary outcome [6] 308169 0
Health care costs as calculated from Department of Human Services records which include Medicare and Pharmaceutical Benefits Scheme costs
Timepoint [6] 308169 0
12 months post treatment and 24 months post treatment

Eligibility
Key inclusion criteria
Aged 65 years and over
2 or more chronic physical diseases
Access to a computer and the internet
Sufficient English to complete questionnaires and take part in the study
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current diagnosis of depression, bipolar or schizophrenia
Drug or alcohol dependence/abuse issue
Has received psychological therapy in the past six months

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed. Potential participants will be assessed for eligibility through a telephone interview. The researcher conducting this interview will be unaware of which group the participant will be allocated to. Eligible participants will be directed to a weblink for an online consent process. Once the online consent process has been completed a researcher will need to contact the holder of the allocation schedule to access the allocation for that participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of numbers used for allocation to groups will be generated by number randomising computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Chi-square goodness of fit tests were planned to compare the two groups on cases of depressive illness. Sample size estimate calculations indicated 197 participants would be needed to detect a significant difference.
Linear Mixed Models analyses were planned to compare the two groups on depressive symptoms over time. An estimated sample of 304 participants would be needed to detect a significant difference. The number was generated from estimates for conducting an ANCOVA.
Sample size estimate calculations were conducted using GPower software. Calculations were based on detecting small to medium effect sizes (f=0.20, Omega squared =.20, f²=0.10), a significance value of 0.05, and power of at least 0.80. A small to medium effect size was used for the calculations because although large effect sizes have been found in treatment trials using the iCBT intervention used in this trial (Titov et al., 2015), as this was a prevention study large effect sizes were unlikely given that the sample being recruited had minimal depressive symptoms at baseline. Furthermore results from a meta-analysis of psychosocial interventions for the prevention of depression in older adults (Forsman et al., 2011) found a small effect size of d= 0.17.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/08/2014
Actual
13/09/2014
Date of last participant enrolment
Anticipated
30/09/2015
Actual
30/09/2016
Date of last data collection
Anticipated
21/12/2018
Actual
4/01/2019
Sample size
Target
300
Accrual to date
Final
302
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 289201 0
University
Name [1] 289201 0
University of Sydney
Country [1] 289201 0
Australia
Primary sponsor type
Individual
Name
Professor Louise Sharpe
Address
Brennan McCallum Building A18
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 287874 0
Individual
Name [1] 287874 0
Dr Blake Dear
Address [1] 287874 0
Centre for Emotional Health
Department of Psychology, C3A 701
Macquarie University NSW 2109
Country [1] 287874 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301040 0
University of Sydney Human Ethics Committee
Ethics committee address [1] 301040 0
Ethics committee country [1] 301040 0
Australia
Date submitted for ethics approval [1] 301040 0
06/11/2013
Approval date [1] 301040 0
03/02/2014
Ethics approval number [1] 301040 0
2013/1029

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

Contacts
Principal investigator
Name 48214 0
Prof Louise Sharpe
Address 48214 0
Brennan McCallum Building A18
The University of Sydney
NSW 2006
Australia
Country 48214 0
Australia
Phone 48214 0
+61 2 9351 4558
Fax 48214 0
Email 48214 0
[email protected]
Contact person for public queries
Name 48215 0
Jennifer Read
Address 48215 0
Brennan McCallum Building A18
The University of Sydney
NSW 2006
Australia
Country 48215 0
Australia
Phone 48215 0
+61 2 9351 4257
Fax 48215 0
Email 48215 0
[email protected]
Contact person for scientific queries
Name 48216 0
Louise Sharpe
Address 48216 0
Brennan McCallum Building A18
The University of Sydney
NSW 2006
Australia
Country 48216 0
Australia
Phone 48216 0
+61 2 9351 4558
Fax 48216 0
Email 48216 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13721Informed consent form    366289-(Uploaded-22-08-2020-09-28-14)-Study-related document.pdf
13722Ethical approval    366289-(Uploaded-22-08-2020-09-30-32)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.