A Letter Intervention in Primary Care Patients to Improve Depression and Anxiety Disorders
A Randomised Controlled Trial of a Letter Intervention in Primary Care Patients to Improve Depression and Anxiety Disorders
1 other identifier
interventional
200
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 depression
Started Jun 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 28, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedNovember 28, 2013
March 1, 2006
1.3 years
March 27, 2006
November 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
score on a depression/anxiety rating scale at 1 month and 3 months
score on a quality of life scale at 1 month and 3 months
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of primary depressive or anxiety disorder
- gender (males and females both eligible)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayside Healthlead
- Beyondblue (The National Depression Initiative)collaborator
Study Sites (1)
Primary Mental Health and Early Intervention Team
Melbourne, Victoria, 3181, Australia
Related Publications (5)
Asch R, Price J, Hawks G. Psychiatric out-patients' reactions to summary letters of their consultations. Br J Med Psychol. 1991 Mar;64(1):3-9. doi: 10.1111/j.2044-8341.1991.tb01637.x.
PMID: 2043503BACKGROUNDDale, 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.
BACKGROUNDJelley 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.
PMID: 12468491BACKGROUNDMarzanski, M., Musunuri, P., & Coupe, T. (2005). Copying letters to patients: A study of patients' views. Psychiatric Bulletin, 29, 56 - 58.
BACKGROUNDNandhra, H., Murray, G., Hymas, N., & Hunt, N. (2004). Medical records: Doctors' and patients' experiences of copying letters to patients. Psychiatric Bulletin, 28, 40 - 42.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael McGartland, MClinPsych
The Alfred
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2006
First Posted
March 28, 2006
Study Start
June 1, 2006
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
November 28, 2013
Record last verified: 2006-03