A Letter Intervention in Primary Care Patients to Improve Depression and Anxiety Disorders

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307697
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : November 28, 2013
Beyondblue (The National Depression Initiative)
Information provided by (Responsible Party):
Bayside Health

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Procedure: receipt of copy of psychiatic assessment letter Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of a Letter Intervention in Primary Care Patients to Improve Depression and Anxiety Disorders
Study Start Date : June 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Primary Outcome Measures :
  1. score on a depression/anxiety rating scale at 1 month and 3 months
  2. score on a quality of life scale at 1 month and 3 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • diagnosis of primary depressive or anxiety disorder
  • gender (males and females both eligible)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00307697

Australia, Victoria
Primary Mental Health and Early Intervention Team
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
Bayside Health
Beyondblue (The National Depression Initiative)
Principal Investigator: Michael McGartland, MClinPsych The Alfred

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.
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.

Responsible Party: Bayside Health Identifier: NCT00307697     History of Changes
Other Study ID Numbers: PMHT-01/06
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: March 2006

Keywords provided by Bayside Health:
Letter intervention
Primary health care

Additional relevant MeSH terms:
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders