A randomised trial of group-delivered cognitive behavioural therapy versus standard pain clinic treatment for chronic pelvic pain

ISRCTN	ISRCTN21012555
DOI	https://doi.org/10.1186/ISRCTN21012555
Secondary identifying numbers	2010UROL02

Submission date: 24/02/2011
Registration date: 31/03/2011
Last edited: 06/11/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Mark Rochester
Scientific

Department of Urology
Norfolk and Norwich University Hospital NHS Foundation Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom

Phone	+44 (0)16 0328 6286
Email	mark.rochester@nnuh.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Self Management Activation Randomised Trial for Prostatitis (SMART-P)
Study acronym	SMART-P
Study objectives	The main objective of the study is to show that a programme of group-directed cognitive behavioural therapy for men with chronic pelvic pain is more effective than standard therapy (pain relief and coping mechanisms delivered by the pain clinic). This will be evaluated by changes in the National Institute of Health Chronic Pelvic Pain Score (NIH-CPPS), a validated scoring system for assessing the severity of the condition which will be measured before and after the intervention. Chronic prostatitis is a severe, debilitating chronic illness suffered by a considerable number of men. A universally effective treatment is lacking which can be frustrating for clinicians and distressing for patients. We aim to improve the treatment of these patients by combining cognitive behavioural therapy, which has been shown to be effective for chronic pain conditions including chronic prostatitis, with group-directed self management which has been shown to be effective for a number of other chronic diseases. We propose to randomise patients to either a self management health and care education programme or to pain clinic referral alone (standard care). We believe that a randomised controlled trial is the most robust method of evaluation of our approach, and will allow us to compare to current available treatment in a scientific manner.
Ethics approval(s)	Norfolk Research Ethics Committee approved on 19th January 2011, ref: 11/H0310/6
Health condition(s) or problem(s) studied	Chronic prostatitis/Chronic pelvic pain syndrome
Intervention	Men will be randomised to attend either a self management health and care education programme or to pain clinic referral alone. Standard care After exclusion of a treatable bacterial cause for CP/CPPS, referral to pain clinic will be as a result of agreement between clinician and patient. Pharmacological agents such as gabapentin, pregabalin and antidepressants are the mainstay of standard care at present. Intervention This group will take part in a course of six weekly small group sessions (five to eight men) developed in conjunction with experts in psychology, pain management and urology, each lasting one hour with a focus on: 1. Understanding physiology of pain 2. Psychological contributors 3. Pain-coping mechanisms 4. Behavioural responses 5. Prevention, rehabilitation and re-enablement 6. Relationships between symptom distress, emotion and pain We will design the sessions to enable the participants to learn techniques of problem solving and goal setting. Supported self care and co-production will be the underlying principles of this programme. The initial session is an introduction to the programme requirements, the rationale and the value of the approach. In early sessions , patients are instructed in the use of the Reaction Record for self-identifying and modifying catastrophic cognition and in understanding how such thinking is associated with greater negative affect, how there is little supportive evidence for such thinking, and how it can lead to poor choices in behavioural coping. During following sessions, patients identify and modify deficits in social support by practicing self-assertion communication exercises with their instructor and then later with significant others in their lives while using the Reaction Record to examine how to better negotiate distressing episodes. Further sessions use the Reaction Record tool to identify and modify illness-focused behavioural coping strategies and also to help re-engage the patient in physical and social activities that they may have abandoned. In the final session, patients are provided with a detailed review of their acquired behavioural modifications. Following this discussion, patients are instructed on continued problem-solving skills and future self-management challenges are discussed. At 2, 6, and 12 months, clinicians not involved in the conduct of the trial will review participants in the urology outpatient departments and perform NIH-CPPS assessment (a validated pain-score for chronic pelvic pain).
Intervention type	Other
Primary outcome measure	1. Changes in the National Institute of Health Chronic Pelvic Pain Score (NIH-CPPS), a validated scoring system for assessing the severity of the condition which will be measured before and after the intervention.
Secondary outcome measures	1. Assess functional status (Hospital Anxiety and Depression (HAD) and SF-36 score) 2. Changes in requirements for pain-relief medication will also be used as a measure of effectiveness 3. Patients degree of self-management/activation will be assessed by the PAM questionnaire The outcomes will be measured before and after the intervention.
Overall study start date	25/03/2011
Completion date	24/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	120
Key inclusion criteria	1. Men with chronic prostatitis (CP)/chronic pelvic pain syndrome (CPPS) refractory to simple pharmacological manipulation from general urology clinics at Norfolk and Norwich University hospitals (NNUH) 2. All patients aged over 18 with a diagnosis of CP/CPPS made by a urologist referred for the first time by their GP 3. Patients must be refractory to antibiotic treatment
Key exclusion criteria	1. Abnormal serum prostate specific antigen (PSA) level 2. Suspected prostate cancer on digital rectal examination 3. Active urinary tract infection 4. Alternative cause for pain found by urologist (e.g. ureteric calculus)
Date of first enrolment	25/03/2011
Date of final enrolment	24/03/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Urology

Norwich
NR4 7UY
United Kingdom

Sponsor information

Norfolk and Norwich University Hospitals NHS FoundationTrust (UK)
Hospital/treatment centre

Research and Development
c/o Kathryn Andrews
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
England
United Kingdom

Phone	+44 (0)16 0328 6611
Email	kathryn.andrews@nnuh.nhs.uk
"ROR"	https://ror.org/01wspv808

Funders

Funder type

Government

Health Enterprise East Ltd (UK)-Regional Innovation Fund

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	study protocol	26/09/2011		Yes	No

Editorial Notes

06/11/2019: Internal review.
08/10/2018: No publications found, verifying study status with principal investigator.