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Trial registered on ANZCTR


Registration number
ACTRN12616001398493
Ethics application status
Approved
Date submitted
5/10/2016
Date registered
10/10/2016
Date last updated
22/04/2020
Date data sharing statement initially provided
19/08/2019
Date results information initially provided
19/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The MIRROR2 pilot study: prevention of Major depressIon among older people living in Regional and RemOte aReas of Western Australia
Scientific title
Randomised controlled trial to determine if a behavioural activation intervention reduces the onset of a Major Depressive Episode in older people with subsyndromal depression living in remote and regional Western Australia.
Secondary ID [1] 286840 0
nil
Universal Trial Number (UTN)
Trial acronym
MIRROR2
Linked study record
ACTRN12616001412426

Health condition
Health condition(s) or problem(s) studied:
Depression 295226 0
Condition category
Condition code
Mental Health 295476 295476 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-help behavioural activation (BA) remotely supported by telephone vs usual care.

Participants randomised to BA will be mailed a specifically-designed self help workbook titled "Helping you to maintain a positive mood in older age". The workbook is based on clear principles of an evidence supported psychological treatment for depression in later life. It outlines relevant information about depression and offers guidance on how to identify depressive symptoms and take action to improve mental wellbeing. In particular, the booklet outlines how to monitor activities, keep a balance between activities and recognise the connection between activity and mood.

To offer support to participants and optimise adherence to the intervention, a behavioural activation therapist will telephone participants on 3 occasions throughout the course of the 8 week program (first call within 2 weeks of randomisation than at week 4 and week 8) with a 4 week interval period between each call. The approximate duration of these telephone sessions will be 20-30 minutes and participants will be asked to complete activities from the workbook during the 4 week interval periods. The BA therapist will encourage participants to complete all relevant activities and participants can spend as much time as they wish completing each relevant stage through the work book.
Intervention code [1] 292002 0
Prevention
Intervention code [2] 296080 0
Behaviour
Comparator / control treatment
Standard Medical Care - Usual care received from the participants General Practitioner and any other care the participant may be receiving from other services.

Control participants will receive a copy of the Behavioural Activation self-help booklet at the end of the study. This will be once the final participant recruited into the study has returned their 52 week follow up health & lifestyle questionnaire which assesses the severity of depressive and anxiety symptoms as measured by the Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001) and the brief measure for assessing Generalized Anxiety Disorder (GAD-7) (Spitzer et al., 2006).
Control group
Active

Outcomes
Primary outcome [1] 295205 0
Onset of a Major Depressive Episode as assessed by Module A (Mood episodes) of the Structured Clinical Interviews for DSM Disorders - 1, Research Version. (SCID - 1).
Timepoint [1] 295205 0
26 weeks post randomisation
Secondary outcome [1] 315044 0
Severity of depressive symptoms, as measured by the Patient Health Questionnaire (PHQ–9).
Timepoint [1] 315044 0
12, 26 and 52 weeks post randomisation
Secondary outcome [2] 328242 0
Severity of anxiety symptoms, as per the brief measure for assessing Generalized Anxiety Disorder (GAD-7).
Timepoint [2] 328242 0
12, 26 and 52 weeks
Secondary outcome [3] 328243 0
Health-related quality of life as measured by the health-related quality of life (SF-12 short form health survey).
Timepoint [3] 328243 0
12, 26 and 52 weeks

Eligibility
Key inclusion criteria
- Aged 65 years or over
- Screens positive on at least one of two questions known as
the "Whooley" depression screening questions: low mood and decreased interest or enjoyment in usual activities.
- Resides in inner (RA2) or outer regional (RA3) or remote (RA4) Western Australia according to the Australian Standard Geographic Classification - Remoteness Areas (ASGC-RA) Classification 2011
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Active suicidal plan
- Current or past history of psychosis
- Sensory impairment that interferes with effective communication over the phone or with reading font size 14
- Clinically significant cognitive impairment as evidenced by a score less than 27 on the Telephone Interview for Cognitive Status(TICSm)(Knopman et al, 2010)
- Plans to move residence during the follow up period
- Presence of a Major Depressive episode as assessed by administration of the SCID - 1

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)
20,000 randomly selected men and women from the Western Australian electoral roll aged 65 years or over residing in regional and remote Western Australia will be posted a project information sheet, consent form, health screening questionnaire and replied paid envelope.

Respondents who return their questionnaires and respond in the affirmative to one of two of the “Whooley” questions contained within the screening questionnaire will be contacted by study staff to confirm eligibility, answer any questions and complete assessment for the presence of a Major Depressive episode utilising the SCID- I. The TICSm will also be administered to ascertain evidence of cognitive impairment.

Participants who meet study entry criteria including the presence of subsyndromal depression (as evidenced by their affirmative answer to one of the Whooley questions and because they do not fulfill criteria for the diagnosis of a Major Depressive episode according to the SCID 1), will be randomly assigned to one of two groups:

Standard Medical Care or Standard Medical Care and Behavioural Activation Intervention

Due to the nature of the study, participants in the intervention group and the behaviour therapist facilitating their efforts will not be blinded to group allocation. Research staff assessing end points (SCID-1) will be blinded and will not have access to information detailing the participant's group status.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation will occur according to a list of random numbers generated by computer. The list will be generated and centrally maintained by the University of Western Australia's Centre for Software Practice, which will have no direct contact with participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will follow CONSORT guidelines. We will use standard descriptive statistics to compare basic sociodemographic and clinical data across treatment arms. We will examine the proportion of participants in each study group who converted to a Major Depressive Episode over the 52 week follow up period with analysis of contingency tables and logistic regression. We will use imputation methods (ICE) to examine the primary outcome on an intention-to-treat basis. Multilevel mixed models will be employed to investigate changes in PHQ-9, GAD-7 and SF-12 scores over 52 weeks.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/02/2016
Date of last participant enrolment
Anticipated
31/10/2018
Actual
1/11/2018
Date of last data collection
Anticipated
31/10/2019
Actual
17/12/2019
Sample size
Target
300
Accrual to date
Final
309
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4983 0
Royal Perth Hospital - Perth

Funding & Sponsors
Funding source category [1] 291387 0
University
Name [1] 291387 0
The University of Western Australia - School of Medicine - Division Psychiatry
Country [1] 291387 0
Australia
Primary sponsor type
University
Name
UWA Medical School - Division Psychiatry
Address
WA Centre for Health & Ageing
6th Floor MRF Building
50 Rear Murray Street
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 290065 0
Other
Name [1] 290065 0
The Western Australia Centre for Health & Ageing
Address [1] 290065 0
WA Centre for Health & Ageing
6th Floor MRF Building
50 Rear Murray Street
Perth WA 6000
Country [1] 290065 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292943 0
Department of Health HREC
Ethics committee address [1] 292943 0
DOHWA HREC
Level 1 C Block
189 Royal Street
East Perth WA 6004
Ethics committee country [1] 292943 0
Australia
Date submitted for ethics approval [1] 292943 0
09/09/2015
Approval date [1] 292943 0
26/10/2015
Ethics approval number [1] 292943 0
2015/48
Ethics committee name [2] 296088 0
The University of Western Australia HREC
Ethics committee address [2] 296088 0
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Perth, Australia
Ethics committee country [2] 296088 0
Australia
Date submitted for ethics approval [2] 296088 0
22/05/2015
Approval date [2] 296088 0
04/08/2015
Ethics approval number [2] 296088 0
RA/4/1/7592

Summary
Brief summary
Symptoms of low mood and depression are common in later life and can include; feeling sad, empty or down, loss of interest or pleasure, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, poor concentration and thoughts about death. There is now evidence that depression is 23% more frequent among people living in regional Australia than in the city, possibly because of difficulty accessing relevant health services.

When feeling low, a person’s motivation to do things can decrease. Some may find that they give up hobbies or activities previously enjoyed, and over time might end up doing very little. This can lead to a further decline in mood and start a vicious cycle that can be difficult to break. One of the ways of overcoming depression and low mood is by changing behaviour, such as gradually increasing activity levels. The results of several studies show that the more activities people engage in the better they feel. Behavioural Activation (BA) interventions encourage participants to meaningfully increase their engagement in activities with the aim of improving mood and sense of achievement.

The current pilot study is seeking to test out (pilot) whether a supported self-help behavioural activation intervention designed for older Western Australians living in regional and remote areas is effective at: preventing the onset of depression among those with some depressive symptoms. The results will be used to improve the program and make it ready for a full clinical trial so that definitive evidence of the effectiveness of the intervention can be obtained.

Specific aim of definitive trial:
To determine the effect of a BA intervention on the 1 year incidence rate of Major Depression in older adults with subsyndromal depression living in regional Western Australia.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57750 0
Prof Osvaldo P Almeida
Address 57750 0
WA Centre for Health & Ageing
Level 6, MRF Building
50 Rear Murray Street
Perth WA 6000
Country 57750 0
Australia
Phone 57750 0
+61 (8) 9224 2855
Fax 57750 0
+61 (8) 9224 8009
Email 57750 0
[email protected]
Contact person for public queries
Name 57751 0
Prof Osvaldo Almeida
Address 57751 0
WA Centre for Health & Ageing
Level 6, MRF Building
50 Rear Murray Street
Perth WA 6000
Country 57751 0
Australia
Phone 57751 0
+61 (8) 9224 2855
Fax 57751 0
+61 (8) 9224 8009
Email 57751 0
[email protected]
Contact person for scientific queries
Name 57752 0
Prof Osvaldo P Almeida
Address 57752 0
WA Centre for Health & Ageing
Level 6, MRF Building
50 Rear Murray Street
Perth WA 6000
Country 57752 0
Australia
Phone 57752 0
+61 (8) 9224 2855
Fax 57752 0
+61 (8) 9224 8009
Email 57752 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
No data can be shared with out consent from individual participants in the study and also due to confidentiality and security reasons.


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
EmbasePreventing depression among older people living in rural areas: A randomised controlled trial of behavioural activation in collaborative care.2021https://dx.doi.org/10.1002/gps.5449
N.B. These documents automatically identified may not have been verified by the study sponsor.