Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
GP practice
Study 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
Primary outcome measure
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 study start date
01/09/2009
Overall study end date
01/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Must be a general practitioner
2. Either sex, any age
Participant type(s)
Patient
Age group
Other
Sex
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
England, United Kingdom
Study 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
England
United Kingdom
Sponsor type
University/education
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|