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Trial registered on ANZCTR


Registration number
ACTRN12612000318886
Ethics application status
Approved
Date submitted
20/03/2012
Date registered
21/03/2012
Date last updated
20/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrated depression management: A trial of a new model of care in a low vision rehabilitation setting
Scientific title
The effect of problem solving treatment for primary care compared to usual care on depressive symptoms in participants undergoing low vision rehabilitation as assessed using the Patient Health Questionnaire (9-Items)
Secondary ID [1] 280175 0
Nil
Universal Trial Number (UTN)
U1111-1129-2935
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 286108 0
Vision Impairment 286109 0
Condition category
Condition code
Mental Health 286301 286301 0 0
Depression
Eye 286302 286302 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Problem solving treatment for primary care (PST-PC) is a manual driven psychological treatment that teaches problem-solving skills. It aims to help people with vision loss find practical solutions to vision-related problems, reduce avoidance behaviours and adopt a positive problem solving orientation. PST-PC will be delivered by PST specialists in eight weekly telephone sessions (30-45mins duration). Following the acute treatment sessions, monthly maintenance sessions with clients will be held over the phone (30-40mins duration) for 10 months following the acute treatment sessions.
Intervention code [1] 284504 0
Behaviour
Intervention code [2] 284509 0
Treatment: Other
Comparator / control treatment
Participants in the control group are encouraged to accept a referral to their GP for more psychological assessment and intervention.

All participants in each group will receive information about depression and have full access to all usual services and community-based services. A letter outlining the client’s level of depressive symptoms and involvement in the study will be sent to the client’s GP.
Control group
Active

Outcomes
Primary outcome [1] 286773 0
Depressive symptoms: Patient Health Questionnaire-9 (PHQ-9).
Timepoint [1] 286773 0
baseline, 3, 6, 12 months
Secondary outcome [1] 296630 0
Nil
Timepoint [1] 296630 0
Nil

Eligibility
Key inclusion criteria
Minimum age: 18 years; both males and females; Low vision care participants; must show at least minimal depressive symptoms (assessed by the Patient Health Questionnaire-9 [PHQ-9]); not be currently receiving any form of treatment for a mental health condition, including psychopharmacological treatment ; living independently in the community; be English-speaking; have adequate hearing to respond to normal conversation; and have no cognitive impairment (as assessed with the 6-item cognitive impairment test).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under age 18; not engaged in low vision rehabilitation services; does not meet the threshold for minimal depressive symptoms on the PHQ-9; is currently engaged in psychologcial or pharmaceutical interventions for a mental health disorder; is not living independently in the community; is not english speaking; does not have adequate hearing to respond to normal conversation; is cognitively impaired.

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)
All interviews will be conducted over the phone by trained research assistants using a computer-assisted interview. Baseline interviews will be collected prior to randomization. Following the baseline assessment, participants will be allocated to the intervention or control groups based on the code contained within the next sequential sealed envelope. Follow-up interviews will be conducted by research staff masked to participant allocation. Breaches of masking will be assessed and reasons obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
7/05/2012
Date of last participant enrolment
Anticipated
Actual
8/08/2014
Date of last data collection
Anticipated
21/12/2017
Actual
Sample size
Target
162
Accrual to date
Final
162
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 284928 0
Government body
Name [1] 284928 0
Australian Research Council
Country [1] 284928 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Beyondblue
Address
PO Box 6100
Hawthorn West VIC 3122
Country
Australia
Secondary sponsor category [1] 283801 0
Charities/Societies/Foundations
Name [1] 283801 0
Vision Australia
Address [1] 283801 0
PO Box 189, Boronia Vic 3155
Country [1] 283801 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286934 0
Eye & ear hospital HREC
Ethics committee address [1] 286934 0
Ethics committee country [1] 286934 0
Australia
Date submitted for ethics approval [1] 286934 0
02/04/2012
Approval date [1] 286934 0
07/05/2012
Ethics approval number [1] 286934 0

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

Contacts
Principal investigator
Name 33946 0
Dr Gwyneth Rees
Address 33946 0
Centre for Eye Research Australia
32 Gisborne St
East Melbourne VIC 3002
Country 33946 0
Australia
Phone 33946 0
+61399298048
Fax 33946 0
Email 33946 0
grees@unimelb.edu.au
Contact person for public queries
Name 17193 0
Gwyneth Rees
Address 17193 0
Centre for Eye Research Australia
Royal Victorian Eye & Ear Hospital
Peter Howson Wing
Level 1, 32 Gisborne Street
East Melbourne VIC
3002 Australia
Country 17193 0
Australia
Phone 17193 0
+61 3 9929-8363
Fax 17193 0
Email 17193 0
grees@unimelb.edu.au
Contact person for scientific queries
Name 8121 0
Gwyneth rees
Address 8121 0
Centre for Eye Research Australia
Royal Victorian Eye & Ear Hospital
Peter Howson Wing
Level 1, 32 Gisborne Street
East Melbourne VIC
3002 Australia
Country 8121 0
Australia
Phone 8121 0
+61 3 9929-8363
Fax 8121 0
Email 8121 0
grees@unimelb.edu.au

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
EmbaseValidated Prediction Model of Depression in Visually Impaired Older Adults.2016https://dx.doi.org/10.1016/j.ophtha.2015.11.028
N.B. These documents automatically identified may not have been verified by the study sponsor.