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

This study has been completed.
Sponsor:
Collaborator:
Beyondblue (The National Depression Initiative)
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00307697
First received: March 27, 2006
Last updated: November 26, 2013
Last verified: March 2006
  Purpose

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 Intervention Phase
Depression
Anxiety
Procedure: receipt of copy of psychiatic assessment letter
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: June 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307697

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

Publications:
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
ClinicalTrials.gov Identifier: NCT00307697     History of Changes
Other Study ID Numbers: PMHT-01/06
Study First Received: March 27, 2006
Last Updated: November 26, 2013
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:
Letter intervention
Depression
Anxiety
Primary health care

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

ClinicalTrials.gov processed this record on April 22, 2014