Condition category
Signs and Symptoms
Date applied
29/09/2011
Date assigned
29/09/2011
Last edited
21/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
-
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

Sponsor information

Organisation

Bath Royal National Hospital for Rheumatic Diseases (UK)

Sponsor details

Bath Royal National Hospital for Rheumatic Diseases
Upper Borough Walls
Bath
BA1 1RL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes