Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000015741
Ethics application status
Approved
Date submitted
10/12/2012
Date registered
7/01/2013
Date last updated
1/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial on the effectiveness of Sir John Kirwan's "the Journal" in secondary care treatment of patients with depression/dysthymia
Scientific title
A randomised controlled trial on the effectiveness of Sir John Kirwan's "the Journal" in secondary care treatment of patients with depression/dysthymia
Secondary ID [1] 281666 0
Nil
Universal Trial Number (UTN)
U1111-1133-9171
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 287919 0
Dysthymia 287920 0
Condition category
Condition code
Mental Health 288300 288300 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Depression is common and disabling but the evidence is that fewer than half of people with depression seek any treatment and few receive any help from specialised mental health professionals. In secondary care treatment is often limited to drug therapies because of long waiting lists to see psychological therapists face to face despite recommendations by NICE and others about the importance of non-drug therapies. One way to address this problem is to use computerised e-therapies which deliver structured cognitive behavioural treatment via a computer. The appeal of e–therapies is that they solve several problems. Firstly, they are convenient for users. They can be used at any time and can be accessed in different locations. Secondly, there is no waiting for appointments. Lastly, for health providers e-therapies address the workforce issue of a lack of trained providers of effective interventions. If e-therapies can be shown to be acceptable, feasible and effective there is no reason why these computerised therapies could not replace humans leaving qualified professionals to focus on more complex management problems. This may lead to the development of new roles. This has been explicitly recognised by Health Workforce New Zealand who stated that mental health services in New Zealand are in a “poor state of repair”, that they need to focus on better use of information technology and health providers need to change professional roles. The new role to be tested in this proposal is an e-case manager.

The attraction of e-therapies has led to a boom in applications directed at the health market. However, there is a lack of evidence for the effectiveness of many e-therapies. Previous randomised controlled trials of e-therapies for depression have mainly been in people recruited through the internet or in clinical populations with mild or “sub-clinical” disorders. The difficulty with these populations is that there is a high rate of spontaneous remission so showing that the e-therapy is no different to usual care has little meaning. A further problem is that many people fail to complete the course of e-therapy (although this also applies to face to face therapies). There is a need for randomised controlled trials of e-therapies in clinical populations using novel techniques to maximise the dose of e-therapy without losing the potential health workforce benefits.

A potentially attractive solution is to enable clinician-assisted computerised cognitive behaviour therapy. In this model the clinician acts in the role of a coach to support the patient progress through the computerised treatment - the clinician does not need to deliver the non-drug therapy themselves. There is some evidence that this can result in significant improvements in depression with reduced demands on clinician time. However the problems with these trials are that they are small and have been done using participants with relatively less severe depression who may not have seen clinicians as part of their usual care. To date there have been no trials of clinician assisted e-therapy in secondary care.

“The Journal”,a free internet based programme for the self-management of depression was developed in New Zealand and capitalises on the social marketing appeal of John Kirwan, an ex All Black who has described his experiences of depression to help destigmatise mental illness. The self-help programme is based on the cognitive behavioural techniques of behavioural activation and problem solving. Usage data shows that the depression.org web site was visited by 700,000 people in its first year with 20,000 registered with The Journal and 13,000 active users. About 1500 people a month register to start the programme with about three quarters of people recording significant improvement. There is no data on who uses the programme but peaks in registration coincide with TV adverts promoting the www.depression.org.nz site. Although the programme was designed for depression of mild to moderate severity, the evidence shows that nearly a third of people who access the programme have more severe depression. However, only one in twenty people who start the programme complete all six lessons and one in ten report no change or a worsening of symptoms. The current data does not show who these people are, how to improve the rate of completion or whether the improvement would have happened without The Journal. A further argument for a trial of The Journal is that despite considerable investment in this programme by the New Zealand tax payer it has not been subjected to any clinical trials and its effectiveness is unproven.

This proposal is for a randomised controlled trial of The Journal in people referred to secondary mental health services with depression using a clinician assisted model in the form of an e-case manager. We hypothesise that patients who are coached by the e-case manager to progress through The Journal will improve quicker, require fewer face to face appointments with clinicians and be more satisfied with their care than people who receive usual care. We also hypothesise that use of the e-case manager will be more cost effective than usual care. The e-case manager will provide support for participants for their journey through The Journal either in weekly face to face or telephone sessions over a total period of 12 weeks. These sessions should last no longer than one hour. The e-case manager will also provide information/feedback to clinicians involved in participant's usual care.
Intervention code [1] 286168 0
Other interventions
Comparator / control treatment
Treatment as usual. This will differ depending on the level of intervention required by participants in the control group but they will be monitored over a 12 week period.
Control group
Active

Outcomes
Primary outcome [1] 288474 0
PHQ-9 to measure severity of depressive symptoms
Timepoint [1] 288474 0
Baseline, 6, 12 weeks
Secondary outcome [1] 300262 0
SF-36 to measure function and well being
Timepoint [1] 300262 0
Baseline, 6, 12 weeks
Secondary outcome [2] 300263 0
EQ-5D to measure health-related quality of life that are related to costs.
Timepoint [2] 300263 0
Baseline, 6, 12 weeks. These tests will be completed at these time points.
Secondary outcome [3] 300264 0
Internet use
Timepoint [3] 300264 0
12 weeks by self report questionnaire
Secondary outcome [4] 300265 0
Cost of treatment. Outpatient appointments, hospital visits, medication use and time off will be monitored to determine this.
Timepoint [4] 300265 0
12 weeks

Eligibility
Key inclusion criteria
Referral to Community Mental Health Team for depression/dysthymia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to speak/understand English as participants are required to be able to operate a computer.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 4737 0
New Zealand
State/province [1] 4737 0

Funding & Sponsors
Funding source category [1] 286441 0
Government body
Name [1] 286441 0
Health Research Council
Country [1] 286441 0
New Zealand
Primary sponsor type
University
Name
Uniservices
Address
70 Symonds Street,
Auckland
Country
New Zealand
Secondary sponsor category [1] 285228 0
None
Name [1] 285228 0
Address [1] 285228 0
Country [1] 285228 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288518 0
Central
Ethics committee address [1] 288518 0
Ethics committee country [1] 288518 0
New Zealand
Date submitted for ethics approval [1] 288518 0
Approval date [1] 288518 0
Ethics approval number [1] 288518 0

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

Contacts
Principal investigator
Name 36462 0
Prof Simon Hatcher
Address 36462 0
University of Ottawa
Department of Psychiatry
1145 Carling Avenue
Ottawa
Ontario K1Z 7K4
Country 36462 0
Canada
Phone 36462 0
+116138098532
Fax 36462 0
Email 36462 0
[email protected]
Contact person for public queries
Name 36463 0
Nicola Collins
Address 36463 0
c/o Uniservices
70 Symonds Street
Auckland
Country 36463 0
New Zealand
Phone 36463 0
+64212422530
Fax 36463 0
Email 36463 0
[email protected]
Contact person for scientific queries
Name 36464 0
Nicola Collins
Address 36464 0
c/o Uniservices
70 Symonds Street
Auckland
Country 36464 0
New Zealand
Phone 36464 0
+64212422530
Fax 36464 0
Email 36464 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.