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

• Register: ISRCTN
• Last refreshed on: 10 December 2019
• Main ID: ISRCTN21012555
• Date of registration: 31/03/2011
• Prospective Registration: No
• Primary sponsor: Norfolk and Norwich University Hospitals NHS FoundationTrust (UK)
• Public title: A randomised trial of group-delivered cognitive behavioural therapy versus standard pain clinic treatment for chronic pelvic pain
• Scientific title: Self Management Activation Randomised Trial for Prostatitis (SMART-P)
• Date of first enrolment: 25/03/2011
• Target sample size: 120
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN21012555
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Mark Rochester

Key inclusion & exclusion criteria

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

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)


Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Chronic prostatitis/Chronic pelvic pain syndrome
Urological and Genital Diseases
Chronic prostatitis

Intervention(s)

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 dist

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

2010UROL02

Nil known

Source(s) of Monetary Support

Health Enterprise East Ltd (UK)-Regional Innovation Fund

Ethics review

Status:
Approval date:
Contact:

Norfolk Research Ethics Committee approved on 19th January 2011, ref: 11/H0310/6

Results

• Results available: Yes
• Date Completed: 24/03/2012