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The MIRROR1 pilot study: treatMent of depressIon among older people living in Regional and RemOte aReas

Randomised controlled trial to determine whether a greater proportion of older people with Major Depression living in remote and regional Western Australia who receive a Behavioural Activation intervention experience remission of the Depressive Episode, compared with usual care.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001412426
Acronym
MIRROR 1
Enrollment
14
Registered
2016-10-11
Start date
2016-02-15
Completion date
2017-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 decreasing the severity of depression amongst those who are depressed. 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 if a greater proportion of older adults with Major Depression living in regional Western Australia randomly assigned to the BA intervention, compared to Standard Care, experience remission of symptoms after 12 weeks.

Interventions

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

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 well-being. 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 30 minutes and participants will be asked to complete activities from the workbook during the 4 week interval period. 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 workbook.

Sponsors

UWA Medical School - Division Psychiatry
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

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 -The presence of a Major Depressive Episode according to DSM-V (SCID 1) - Fluent in written and spoken english

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 lower than 27 on the Telephone Interview for Cognitive Status(TICSm)(Knopman et al, 2010) - Plans to move residence during the follow up period - Does not reside in inner or outer regional or remote Western Australia

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026