Primary care evidence-based psychological interventions collaboration (PEP)

ISRCTN ISRCTN62481969
DOI https://doi.org/10.1186/ISRCTN62481969
Secondary identifying numbers N/A
Submission date
30/11/2005
Registration date
22/03/2006
Last edited
02/05/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Grant Blashki
Scientific

200 Berkeley Street
Carlton
Victoria
3053
Australia

Phone +61 (0)3 8344 7276
Email gblashki@unimelb.edu.au

Study information

Study designThis study is a randomised controlled trial of CBT training with general practitioners randomised to training and waitlisted (control) groups
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titlePrimary care evidence-based psychological interventions collaboration (PEP)
Study acronymPEP
Study objectivesThe 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(s)Ethics approval has been obtained from the Monash University Standing Committee on Ethics in Research Involving Humans, reference numbers: 154 and 544
Health condition(s) or problem(s) studiedDepressive disorder
InterventionPre 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 typeOther
Primary outcome measureGPs:
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 measuresComparison of pre-training GP knowledge and attitudes with performance in simulated consultations will be undertaken
Overall study start date01/06/2004
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants40 GPs; 100 Patients
Total final enrolment55
Key inclusion criteriaGPs:
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
Key exclusion criteriaPatients:
1. Psychotic disorder
2. Personality disorder
3. Moderate or high suicide risk
Date of first enrolment01/06/2004
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Australia

Study participating centre

200 Berkeley Street
Victoria
3053
Australia

Sponsor information

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

PO Box 6100
West Hawthorn
3122
Australia

Phone +61 (0)3 9810 6100
Email bb@beyondblue.org.au
Website http://www.beyondblue.org.au
ROR logo "ROR" https://ror.org/05mwvz623

Funders

Funder type

Government

The beyondblue Victorian Centre of Excellence in Depression and Related Disorders

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 16/06/2008 02/05/2019 Yes No

Editorial Notes

02/05/2019: Publication reference and total final enrolment added.