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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00307697




Registration number
NCT00307697
Ethics application status
Date submitted
27/03/2006
Date registered
28/03/2006
Date last updated
28/11/2013

Titles & IDs
Public title
A Letter Intervention in Primary Care Patients to Improve Depression and Anxiety Disorders
Scientific title
A Randomised Controlled Trial of a Letter Intervention in Primary Care Patients to Improve Depression and Anxiety Disorders
Secondary ID [1] 0 0
PMHT-01/06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Anxiety 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - receipt of copy of psychiatic assessment letter

Treatment: Surgery: receipt of copy of psychiatic assessment letter
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
score on a depression/anxiety rating scale at 1 month and 3 months
Timepoint [1] 0 0
Primary outcome [2] 0 0
score on a quality of life scale at 1 month and 3 months
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- diagnosis of primary depressive or anxiety disorder

- gender (males and females both eligible)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- primary substance abuse disorder (though co-morbid substance abuse will not be an
exclusion criterion)

- significant personality disorder

- psychosis

- high suicidal risk or risk of harm to others

- inability to speak and read English to a standard that allows independent completion
of the questionnaires

- under 18 years of age

- incapable of giving consent

- significant medical condition

- 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)
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
Factorial
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2007
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Primary Mental Health and Early Intervention Team - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Beyondblue (The National Depression Initiative)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Currently patients thought to have anxiety or depression by their GPs are referred to the
Primary Mental Health Team (PMHEIT) for psychiatric assessment. This assessment consists of a
one-hour interview with a senior psychiatry registrar or psychiatrist, who then writes a
letter to the referring GP. The letter contains diagnostic information and management
recommendations. It is not current practice to send a copy of this letter to the patient. We
hypothesize that patients who receive a copy of the psychiatric assessment letter that is
sent to GPs will improve adherence to treatment recommendations; and that patients who
receive a copy of the letter will have improved outcomes.

GPs will be asked to agree to the participation of their patients. Participants will be
persons over the age of 18 years who are referred to the PMHEIT for assessment and who
receive primary diagnoses of depression or anxiety. After the assessment interview, the
patient will be given an explanatory letter and a consent form. Consenting patients will
complete the Depression and Anxiety Stress Scales (DASS) and a SF12 questionnaire to measure
the level of disability they are experiencing due to their mental condition.

Participants will be randomly allocated into two groups: a control group who will not receive
a copy of the assessment letter, and an experimental group who will be mailed a copy of the
same information that their GP receives. The registrar who conducts the assessment and writes
the report will not know to which group each participant has been assigned. Thus, the content
of the letter will not be affected by knowledge that the patient will or will not see it. The
letter will be sent simultaneously to the referring GP and to experimental group
participants. To ensure confidentiality, the letter will be sent by registered mail.

Three weeks later, participants will be mailed a copy of the DASS. After a week, they will be
contacted by phone and asked for their DASS responses. They will also be asked a brief series
of questions regarding their adherence to the treatment recommendations given in their
assessment letter. When adherence is partial or absent, the interviewer will attempt to
ascertain the reason. This procedure will be repeated at 3 months, except that assessment on
the SF12 will also take place.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00307697
Trial related presentations / publications
Asch R, Price J, Hawks G. Psychiatric out-patients' reactions to summary letters of their consultations. Br J Med Psychol. 1991 Mar;64 ( Pt 1):3-9. doi: 10.1111/j.2044-8341.1991.tb01637.x.
Dale, J., Tadros, G., Adams, S., & Deshpande, N. (2004). Do patients really want copies of their GP letters? A questionnaire survey of older adults and their carers. Psychiatric Bulletin, 28, 199 - 200.
Jelley D, van Zwanenberg T, Walker C. Copying letters to patients. Concerns of clinicians and patients need to be addressed first. BMJ. 2002 Dec 7;325(7376):1359. No abstract available.
Marzanski, M., Musunuri, P., & Coupe, T. (2005). Copying letters to patients: A study of patients' views. Psychiatric Bulletin, 29, 56 - 58.
Nandhra, H., Murray, G., Hymas, N., & Hunt, N. (2004). Medical records: Doctors' and patients' experiences of copying letters to patients. Psychiatric Bulletin, 28, 40 - 42.
Public notes

Contacts
Principal investigator
Name 0 0
Michael McGartland, MClinPsych
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00307697