Plain English Summary
Background and study aims
The aim of the research is to see whether a treatment for the management of chronic pain which currently takes place in an intensive hospital-based program could be helpful for patients in the community. The treatment is a psychological therapy and the sessions would help you to gain a more careful understanding of experiences related to pain and the actions taken in relation to these.
Who can participate?
You can take part if you are over 18 and have had pain for more than 3 months.
What does the study involve?
To take part in the research we will ask you to complete some forms and questionnaires about your pain and health. You will then either be put into the group that takes part in four, four hour treatment sessions over two weeks, or the group that is asked to continue with their current treatment as usual. This will be done randomly. You will also be asked to complete the questionnaires a further two times.
What are the possible benefits and risks of participating?
If you are placed in the 'treatment as usual' group you are unlikely to experience any benefit to your health by taking part. However, you will be helping us understand more about chronic pain which may help us develop ways to help manage it. If you are placed in the psychological therapy group we do not know whether you will experience any benefit as this treatment has not been tested under these circumstances before. However, it is beneficial for the average person with chronic pain. There are no known risks in taking part in this research.
Where is the study run from?
This research is run by the Royal National Hospital for Rheumatic Diseases, Bath, and the Centre for Pain Research, University of Bath. If you are invited to take part in treatment sessions this will be at a GP surgery near where you live at set times and dates.
When is the study starting and how long is it expected to run for?
The study is starting in November 2011 and running until September 2012. We will be recruiting participants from different area at different times. Overall, we will be recruiting participants until March 2012.
Who is funding the study?
The study is funded by a National Institute for Health Research (NIHR) 'Research for Patient Benefit' grant.
Who is the main contact?
Dr Charlotte Boichat
C.S.Boichat@bath.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Charlotte Boichat
ORCID ID
Contact details
Centre for Pain Research
The Avenue
Claverton Down
Bath
BA2 7AY
United Kingdom
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C.S.Boichat@bath.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10877
Study information
Scientific title
Contextual Cognitive-Behavioural Therapy (CBT) for the Self-Management of Chronic Pain in the Community: A Feasibility Study: Phase 2
Acronym
Study hypothesis
The proposed study is phase 2 of a study. Phase 1 aimed to develop a psychologically-based treatment for chronic pain called Contextual Cognitive Behavioural Therapy for delivery in community settings. The aim of this second phase is to conduct a pilot and feasibility trial of this treatment which has been developed through phase 1, with patients with chronic pain in primary care to determine whether further study is likely to be useful and to guide the design of this further research. This type of treatment is usually delivered at tertiary care level and so the research question being addressed here is whether this treatment can be translated for use in the community and whether it is effective at this level. Participants will be randomised to either the treatment (approximately 16 hours of treatment total) or a treatment as usual condition.
Ethics approval
11/SW/0010
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Charlotte Boichat [C.S.Boichat@bath.ac.uk] to request a patient information sheet
Condition
Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention
Contextual CBT: Contextual Cognitive Behavioural Therapy for chronic pain focuses on undermining core processes of suffering and disability, including avoidance, preoccupation with the past or future, verbally-based behavioural rigidity, and failures of values-based action.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Treatment evaluation: evaluated using measurement of recruitment rates, qualitative interview and a questionnaire to measure acceptability and credibility for patients. Timepoint(s): After treatment (or equivalent for control group)
Secondary outcome measures
1. Depression (PHQ-9); Timepoint(s): Before randomisation, after treatment (or equivalent for control group), and three months later
2. Health Survey (SF-36); Timepoint(s): Before randomisation, after treatment (or equivalent for control group), and three months later
3. Healthcare and medication use; Timepoint(s): Before randomisation, after treatment (or equivalent for control group), and three months later
4. Modified Patient Global Impression of Change Scale (PGIC); Timepoint(s): After treatment (or equivalent for control group), and three months later
5. Pain intensity; Timepoint(s): Before randomisation, after treatment (or equivalent for control group), and three months later
6. Quality of life (EuroQol EQ-5D); Timepoint(s): Before randomisation, after treatment (or equivalent for control group), and three months later
7. Roland Morris Disability Questionnaire (RMDQ); Timepoint(s): Before randomisation, after treatment (or equivalent for control group), and three months later
8. The Acceptance and Action Questionnaire - II (AAQ - II); Timepoint(s): Before randomisation, after treatment (or equivalent for control group), and three months later
9. The Chronic PAin Acceptance Questionnaire (CPAQ); Timepoint(s): Before randomisation, after treatment (or equivalent for control group), and three months later
Overall trial start date
03/10/2011
Overall trial end date
30/09/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Living with chronic pain every day or most days for three months or more
2. Having sought treatment for pain from the general practitioner (GP) in the past six months
3. Continuing analgesic use
4. Reporting significant interference with daily social or physical activities or reporting significant depression or anxiety related to pain
5. Aged at least 18 years
6. Willingness and ability to take part
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60
Participant exclusion criteria
1. Inability to participate due to limits communicating in English
2. Inability to participate due to conditions such as severe depression, anxiety disorders, psychotic disorders, or personality disorders, or cognitive impairment
3. Presence of a disease condition that requires specialist medical assessment or treatment (such as a newly diagnosed rheumatologic condition and not currently in maintenance treatment), or cancer, or having a medical condition that makes moderate exercise or increasing activity inappropriate
Recruitment start date
03/10/2011
Recruitment end date
01/03/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Pain Research
Bath
BA2 7AY
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)
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
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24035351
Publication citations
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Results
McCracken LM, Sato A, Taylor GJ, A trial of a brief group-based form of acceptance and commitment therapy (ACT) for chronic pain in general practice: pilot outcome and process results., J Pain, 2013, 14, 11, 1398-1406, doi: 10.1016/j.jpain.2013.06.011.