Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000041752
Ethics application status
Approved
Date submitted
13/12/2012
Date registered
14/01/2013
Date last updated
7/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of a brief mental health intervention for mild mental health syndromes in primary care
Scientific title
Cluster RCT of the impact on distress and functioning of an ultra brief guided self help intervention for common mental health syndromes in primary care compared to treatment as usual
Secondary ID [1] 281670 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Common mild mental health syndromes 287957 0
Condition category
Condition code
Mental Health 288341 288341 0 0
Depression
Mental Health 288447 288447 0 0
Anxiety
Mental Health 288448 288448 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 brief guided self help sessions (one hour total: one 30 minute & 2 fiften minute sessions) provided by GP in primary care setting, over a 5 week period, using cognitive behaviour therapy based treatment manual and self help booklets
Intervention code [1] 286205 0
Behaviour
Intervention code [2] 286206 0
Treatment: Other
Comparator / control treatment
Practice as usual
Control group
Active

Outcomes
Primary outcome [1] 288507 0
K10 scores to assess psychological distress
Timepoint [1] 288507 0
Start and end of treatment
Secondary outcome [1] 300347 0
Hosital Anxiety and Depression Scale
Timepoint [1] 300347 0
Start and end of treatment
Secondary outcome [2] 300600 0
Work and Social Adjustment Scale to assess functioning
Timepoint [2] 300600 0
Start and end of treatment
Secondary outcome [3] 306833 0
EQ5D-3L to assess quality of life
Timepoint [3] 306833 0
Start and end of treatment

Eligibility
Key inclusion criteria
K-10 scores 35 or below, Age 18-65, no significant cognitive impairment, able to communicate in english, not suicidal in past 2 weeks
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant cognitive impairment, suicidal ideation in the past 2 weeks, unable to communicate in english

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be recruited by their treating GP.
Participating GP practices will be randomised by practice into treatment arm and practice as usual.A sequence of random allocations (of the GP practices, rather than individual patients) will be generated using a random number in a statistical package (SAS). An initial allocation list will be produced for all participating practices, with half assisnged to intervention and half assigned to control. Initial ranomisation will be stratified by GP practice size. Any subsequent recruitment of more GP practices will be randomised in a similar fashion in blocks of four practices
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
15/02/2013
Actual
1/05/2013
Date of last participant enrolment
Anticipated
31/01/2015
Actual
1/07/2016
Date of last data collection
Anticipated
Actual
1/01/2017
Sample size
Target
240
Accrual to date
Final
189
Recruitment outside Australia
Country [1] 4750 0
New Zealand
State/province [1] 4750 0
Wellington

Funding & Sponsors
Funding source category [1] 286462 0
University
Name [1] 286462 0
University of Otago
Country [1] 286462 0
New Zealand
Funding source category [2] 286463 0
Other
Name [2] 286463 0
Compass Primary Health Organisation
Country [2] 286463 0
New Zealand
Funding source category [3] 288983 0
Charities/Societies/Foundations
Name [3] 288983 0
Wellington Medical Research Foundation
Country [3] 288983 0
New Zealand
Funding source category [4] 288984 0
Charities/Societies/Foundations
Name [4] 288984 0
Oakley Mental Health Research Foundation
Country [4] 288984 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Wellington
Address
PO Box 7343, Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 285251 0
Other
Name [1] 285251 0
Compass Health, Primary Health Organisation
Address [1] 285251 0
PO Box 27 380 Marion Square, Wellington
6141, New Zealand
Country [1] 285251 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288539 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 288539 0
Ministry of Health, PO Box 5013, Wellington 6011
Ethics committee country [1] 288539 0
New Zealand
Date submitted for ethics approval [1] 288539 0
Approval date [1] 288539 0
21/11/2012
Ethics approval number [1] 288539 0
12/NTB/2

Summary
Brief summary
This study is evaluating the effectiveness of a brief mental health intervention delivered by GPs in primary care. It is comparing it to treatment as usual to see if it is effective.
Trial website
Trial related presentations / publications
Collings, S., Mathieson, F., Dowell, A. Stanley, J.,Hatcher, S., Goodyear-Smith, F., Lane, B. & Munsterman, A.(2015).The clinical and cost-effectiveness of an ultra-brief intervention for common mental health syndromes in primary care: study protocol for a cluster RCT. Trials 06/2015; 16(1):260. DOI:10.1186/s13063-015-0778-y
Mathieson, F., Collings, S., Dowell, A., Goodyear-Smith, F. Stanley, J., Hatcher, S. (2013). Collaborative research: a case example of dissemination of CBT in primary care. The Cognitive Behaviour Therapist. Vol 6 e4, 1-13
Mathieson, F., Stanley, J., Collings, S., Tester, R. & Dowell, A. (submitted April 2018) A cluster randomised controlled trial of a guided self-help mental health intervention in primary care. BMJ Open
Mathieson, F., & Collings, S. (2009) Sub-threshold mental health syndromes: Finding an alternative to the medication of unhappiness. Journal of Primary Health Care. Vol 1, (1), 74-76.
Mathieson, F., Mihaere, K., Collings, S., Dowell, A. & Stanley, J. (2012). Maori cultural adaptation of a brief mental health intervention in primary care. Journal of Primary Health Care, 4 (3): 231-238.
Collings, S. , Mathieson, F., Dowell, A., Stanley, J., Jenkin, G., Goodyear-Smith, F. & Hatcher, S (2011) Acceptability of a self help mental health intervention in general practice. Family Practice. 0:1-7. doi: 10.1093/fampra/cmr066. URI 201644.pdf.
Public notes

Contacts
Principal investigator
Name 36606 0
Ms Fiona Mathieson
Address 36606 0
Department of Psychological Medicine
University of Otago,Wellington
PO Box 7343, Wellington 6242
Country 36606 0
New Zealand
Phone 36606 0
64 4 9186034
Fax 36606 0
64 4 3855877
Email 36606 0
fiona.mathieson@otago.ac.nz
Contact person for public queries
Name 36607 0
Ms Fiona Mathieson
Address 36607 0
Department of Psychological Medicine
University of Otago,Wellington
PO Box 7343, Wellington 6242
Country 36607 0
New Zealand
Phone 36607 0
64 4 9186034
Fax 36607 0
64 4 3855877
Email 36607 0
fiona.mathieson@otago.ac.nz
Contact person for scientific queries
Name 36608 0
Prof Sunny Collings
Address 36608 0
Deans Department
University of Otago,Wellington
PO Box 7343, Wellington 6242
Country 36608 0
New Zealand
Phone 36608 0
64 4 3855541
Fax 36608 0
64 4 3855877
Email 36608 0
sunny.collings@otago.ac.nz

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
EmbaseClinical effectiveness of an ultra-brief intervention for common mental health syndromes in primary care: Study protocol for a cluster randomized controlled trial.2015https://dx.doi.org/10.1186/s13063-015-0778-y
EmbaseCluster randomised controlled trial of a guided self-help mental health intervention in primary care.2019https://dx.doi.org/10.1136/bmjopen-2018-023481
N.B. These documents automatically identified may not have been verified by the study sponsor.