Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000111572
Ethics application status
Approved
Date submitted
24/03/2006
Date registered
29/03/2006
Date last updated
29/03/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of a letter intervention in primary care patients to improve depression and anxiety disorders
Scientific title
A randomised controlled trial of a letter intervention to assess psychiatric severity in primary care patients who have depressive and anxiety disorders
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
DSM-IV Axis 1 Depressive and Anxiety Disorders 1077 0
Condition category
Condition code
Mental Health 1156 1156 0 0
Anxiety
Mental Health 1157 1157 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in experimental group receive a copy of the psychiatric assessment letter that is usually sent to the GP.
Intervention code [1] 954 0
Behaviour
Comparator / control treatment
Control group participants will receive a thank-you letter only.
Control group
Active

Outcomes
Primary outcome [1] 1557 0
Severity of psychiatric condition
Timepoint [1] 1557 0
At baseline, 1 month and 3 months
Secondary outcome [1] 2804 0
Adherence to treatment recommendations.
Timepoint [1] 2804 0
At 1 month and 3 months.

Eligibility
Key inclusion criteria
Primary depressive or anxiety disorder.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Substance abuse disorder, personality disorder, psychosis, risk of harm to self or others, unable to speak or read English, significant medical illness, incapable of consent, clinician discretion.

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



Intervention assignment
Factorial
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1264 0
Charities/Societies/Foundations
Name [1] 1264 0
Beyondblue
Country [1] 1264 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
Country
Australia
Secondary sponsor category [1] 1119 0
None
Name [1] 1119 0
Nil
Address [1] 1119 0
Country [1] 1119 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose of the study is to investigate whether patients who receive a copy of the psychiatric assessement letter that is sent to their GP have improved adherence to treatment recommendations.
There are two hypotheses:
1. receiving the assessment report will improve patient adherence to treatment recommendations;
2. that receiving the assessment report will improve patient outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36334 0
Address 36334 0
Country 36334 0
Phone 36334 0
Fax 36334 0
Email 36334 0
Contact person for public queries
Name 10143 0
Michael McGartland
Address 10143 0
The Alfred Hospital
Commercial Rd
Prahran VIC 3181
Country 10143 0
Australia
Phone 10143 0
+61 3 98044444
Fax 10143 0
Email 10143 0
[email protected]
Contact person for scientific queries
Name 1071 0
Clare Graydon
Address 1071 0
The Alfred Hospital
Commerical Rd
Prahran VIC 3181
Country 1071 0
Australia
Phone 1071 0
+61 3 98044444
Fax 1071 0
Email 1071 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.