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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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]

PMHT-01/06

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Anxiety

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

score on a depression/anxiety rating scale at 1 month and 3 months

Timepoint [1]

Primary outcome [2]

score on a quality of life scale at 1 month and 3 months

Timepoint [2]

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]

Primary Mental Health and Early Intervention Team - Melbourne

Recruitment postcode(s) [1]

3181 - Melbourne

Funding & Sponsors

Primary sponsor type

Government body

Name

Bayside Health

Address

Country

Other collaborator category [1]

Other

Name [1]

Beyondblue (The National Depression Initiative)

Address [1]

Country [1]

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/study/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

Michael McGartland, MClinPsych

Address

The Alfred

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00307697

Trial Review

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