Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000183684
Ethics application status
Approved
Date submitted
18/08/2005
Date registered
19/08/2005
Date last updated
27/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A correspondence-based program to prevent relapse of depression.
Scientific title
Detection of relapse risk and improvement of health risk behaviours in people with depression: Randomised controlled trial of correspondence-based assistance to general practitioners.
Secondary ID [1] 280411 0
Nil
Universal Trial Number (UTN)
Trial acronym
On Track
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 279 0
Condition category
Condition code
Mental Health 316 316 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project evaluates whether correspondence programs for depression, that focus on working with general practitioners to maintain physical or mental health, result in adoption of healthier lifestyles and consequently reduce the risk of relapse. Participants are assigned to one of two treatment conditions. The depression prevention condition involves monitoring triggers and early warning signs, increasing pleasurable events, planning for relapse prevention and building social support. The physical health condition involves increasing physical activitiy, addressing smoking and improving diet and oral health. In each condition participants receive four fortnightly and three monthly letters describing the program elements and how to apply them. After six months, participants switch conditions and receive the alternate treatment program.
Intervention code [1] 211 0
Treatment: Other
Comparator / control treatment
Everyone receives both treatment streams, but half will start with one type then swtich to the other at six months.
Control group
Active

Outcomes
Primary outcome [1] 369 0
The primary outcome is change in depression symptoms. This will be measured using the Beck Depression Inventory-II and mood monitoring forms.
Timepoint [1] 369 0
The forms will be administered prior to commencement of treatment, throughout the treatment and six and 12 months after the completion of the two treatment programs.
Primary outcome [2] 370 0
Change in severity of depression. This will be measured using the Beck Depression Inventory-II and mood monitoring forms.
Timepoint [2] 370 0
The forms will be administered prior to commencement of treatment, throughout the treatment and six and 12 months after the completion of the two treatment programs.
Secondary outcome [1] 826 0
There are numerous key secondary outcomes being measured. These include but are not limited to frequency of trigger and early warning sign monitoring, engagement in pleasurable activities, number and access of social supports, amount of physical activity per week, and changes in diet and oral health practices.
Timepoint [1] 826 0
These will be measured prior to commencement of treatment, throughout treatment and six and 12 months after the completion of the two treatment programs.

Eligibility
Key inclusion criteria
History of Major Depressive Episode but not currently meeting DSM-IV criteria for an episode.- sufficient oral and written English to be able to participate without translation.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of, or current, psychotic disorder- current dependence on any psychoactive substance (excluding nicotine and caffeine)- in other concurrent treatment for depression (other than maintenance antidepressant medication).- enrolled at same address as someone already involved in the study.

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)
Allocations will be placed in sealed envelopes by a person not connected with the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The independent allocator will use random permutations of 1-4 and 1-6 (even vs odd) to minimise guessing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 372 0
Charities/Societies/Foundations
Name [1] 372 0
Australian Rotary Health Research Fund
Country [1] 372 0
Australia
Primary sponsor type
Individual
Name
Professor David J. Kavanagh
Address
IHBI, GPO Box 2434, Brisbane QLD 4001
Country
Australia
Secondary sponsor category [1] 295 0
Individual
Name [1] 295 0
Dr Robert King
Address [1] 295 0
School of Medicine, K floor, Mental Health Centre, RBWH, Herston, QLD, 4029
Country [1] 295 0
Australia
Secondary sponsor category [2] 296 0
Individual
Name [2] 296 0
Dr Jason Connor
Address [2] 296 0
School of Medicine, K floor, Mental Health Centre, RBWH, Herston, QLD, 4029
Country [2] 296 0
Australia
Secondary sponsor category [3] 297 0
Individual
Name [3] 297 0
Prof Frank Deane
Address [3] 297 0
Faculty of Health & Behavioural Sciences
University of Wollongong
Wollongong NSW 2522
Country [3] 297 0
Australia
Secondary sponsor category [4] 298 0
Individual
Name [4] 298 0
Dr Angela White
Address [4] 298 0
Unknown
Country [4] 298 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1362 0
The University of Queensland Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [1] 1362 0
Ethics committee country [1] 1362 0
Australia
Date submitted for ethics approval [1] 1362 0
Approval date [1] 1362 0
Ethics approval number [1] 1362 0

Summary
Brief summary
This project evaluates whether correspondence programs for depression, that focus on working with general practitioners to maintain physical or mental health, result in adoption of healthier lifestyles and consequently reduce the risk of relapse. Participants are assigned to one of two treatment conditions. The depression prevention condition involves monitoring triggers and early warning signs, increasing pleasurable events, planning for relapse prevention and building social support. The physical health condition involves increasing physical activitiy, addressing smoking and improving diet and oral health. In each condition participants receive four fortnightly and three monthly letters describing the program elements and how to apply them. After six months, participants switch conditions and receive the alternate treatment program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35762 0
Address 35762 0
Country 35762 0
Phone 35762 0
Fax 35762 0
Email 35762 0
Contact person for public queries
Name 9400 0
Jennifer Connolly
Address 9400 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country 9400 0
Australia
Phone 9400 0
+61 7 31380048
Fax 9400 0
+61 7 31386030
Email 9400 0
[email protected]
Contact person for scientific queries
Name 328 0
Prof David Kavanagh
Address 328 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country 328 0
Australia
Phone 328 0
+61 7 31386143
Fax 328 0
+61 7 31386030
Email 328 0
[email protected]

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
No additional documents have been identified.