NCT00307697

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_1 depression

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 28, 2013

Status Verified

March 1, 2006

Enrollment Period

1.3 years

First QC Date

March 27, 2006

Last Update Submit

November 26, 2013

Conditions

Keywords

Letter interventionDepressionAnxietyPrimary health care

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Primary Mental Health and Early Intervention Team

Melbourne, Victoria, 3181, Australia

Location

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: 2043503BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 12468491BACKGROUND
  • Marzanski, M., Musunuri, P., & Coupe, T. (2005). Copying letters to patients: A study of patients' views. Psychiatric Bulletin, 29, 56 - 58.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Michael McGartland, MClinPsych

    The Alfred

    PRINCIPAL INVESTIGATOR

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

Locations