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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list