Condition category
Signs and Symptoms
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
14/08/2014
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

Ms Lisa Austin

ORCID ID

Contact details

University of Bath
Norwood house
Bath
BA2 7AY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6840

Study information

Scientific title

A pilot trial of training in psychological flexibility to improve analgesic prescription for chronic pain in general practice

Acronym

Study hypothesis

Can a session of training in psychological flexibility (based on Acceptance and Commitment Therapy [ACT]) have an affect on the way GPs prescribe opioid analgesics to patients with chronic pain and their wellbeing, compared with a control condition?

Ethics approval

Bath Research Ethics Committee, 01/09/2008, ref: 08/H0101/115

Study design

Multicentre non-randomised interventional trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please contact Charlotte Mounce at C.S.Mounce@bath.ac.uk to request a patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes, Primary Care Research Network for England; Subtopic: Generic Health Relevance (all Subtopics); Disease: Other

Intervention

Intervention group: half a day lecture session with exercises and group work using principles of ACT - psychological flexibility and mindfulness.
Control group: half a day lecture session on guidelines related to pain and exercises and group work based on motivational interviewing techniques.

Follow-up questionnaires two weeks later. Fifty minute lecture on prescribing opioids for persistent pain (all participants).

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

GP self-reported prescribing, measured at the start of the training day, and two weeks later.

Secondary outcome measures

Psychological acceptance, measured at the start of the training day, at the end of the training day, and two weeks later.

Overall trial start date

01/09/2009

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Must be a general practitioner
2. Either sex, any age

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Planned sample size: 196

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2009

Recruitment end date

01/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bath
Bath
BA2 7AY
United Kingdom

Sponsor information

Organisation

University of Bath (UK)

Sponsor details

The Avenue
Claverton Down
Bath
BA2 7AY
United Kingdom

Sponsor type

University/education

Website

http://www.bath.ac.uk

Funders

Funder type

Industry

Funder name

Reckitt Benckiser (UK)

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