Condition category
Mental and Behavioural Disorders
Date applied
30/11/2005
Date assigned
22/03/2006
Last edited
22/03/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Grant Blashki

ORCID ID

Contact details

200 Berkeley Street
Carlton
Victoria
3053
Australia
+61 (0)3 8344 7276
gblashki@unimelb.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PEP

Study hypothesis

The objectives of this study are to examine whether general practitioners (GPs) who have completed training in cognitive behavioural therapy (CBT) demonstrate:
1. An increased knowledge of CBT
2. An increase in confidence and reported feasibility of delivering CBT in general practice
3. An improvement in the quality of CBT they deliver in simulated role-plays
4. Improved clinical outcomes for depressed patients

Ethics approval

Ethics approval has been obtained from the Monash University Standing Committee on Ethics in Research Involving Humans, reference numbers: 154 and 544

Study design

This study is a randomised controlled trial of CBT training with general practitioners randomised to training and waitlisted (control) groups

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Depressive disorder

Intervention

Pre and post measures of knowledge, attitudes and practices (KAP) will be measured with questionnaires, as well as videotaped simulated consultations rated with standardised instruments to measure competence. Enrolled GPs will each recruit depressed patients who will be followed up for six months during the course of the study using a suite of quantitative outcome measures (PEP pack patient survey). A subset of these patients will be recruited for more in-depth qualitative interviews to assess consumers’ and carers’ experience of care.

The intervention group receive the CBT program which is a 20-hour face to face skills based program facilitated by specialist mental health care providers or GPs with independent mental health qualifications. Groups of 10-14 GPs per group participate in multiple role-play exercises guided by video-based skills demonstrations, and detailed GP or patient workbooks. The program specifically covers process issues such as integrating psychological skills into general practice, engaging the patient and structuring consultations, as well as specific content issues. The CBT program is an accredited level 2 training program with the Australian general practice mental health standards collaboration.

The control group receive no training initially but are waitlisted to subsequently receive the same training.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

GPs:
1. Improvement in knowledge
2. Attitudes and performance in simulated consultations


Patients:
1. Improvement in depressive symptoms
2. Quality of life and disability

Secondary outcome measures

Comparison of pre-training GP knowledge and attitudes with performance in simulated consultations will be undertaken

Overall trial start date

01/06/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

GPs:
1. Registered GPs in the state of Victoria, Australia

Patients:
1. 18-65 years old
2. Adequate English skills
3. Regular patient of the GP
4. GP diagnosis of depression
5. Patient health questionnaire (PHQ-9) score >10
6. GP intends to manage the patient’s depressive illness

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 GPs; 100 Patients

Participant exclusion criteria

Patients:
1. Psychotic disorder
2. Personality disorder
3. Moderate or high suicide risk

Recruitment start date

01/06/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Australia

Trial participating centre

200 Berkeley Street
Victoria
3053
Australia

Sponsor information

Organisation

The beyondblue Victorian Centre of Excellence in Depression and Related Disorders (Australia)

Sponsor details

PO Box 6100
West Hawthorn
3122
Australia
+61 (0)3 9810 6100
bb@beyondblue.org.au

Sponsor type

Government

Website

http://www.beyondblue.org.au

Funders

Funder type

Government

Funder name

The beyondblue Victorian Centre of Excellence in Depression and Related Disorders

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes