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Group ACT for CD Pain- a Feasibility Study

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ClinicalTrials.gov Identifier: NCT05418062
Recruitment Status : Recruiting
First Posted : June 14, 2022
Last Update Posted : January 18, 2023
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Brief Summary:

Pain is a common symptom of inflammatory bowel disease (IBD) and has a significant impact on patient quality of life. Pain will frequently be the presenting complaint and is experienced throughout the disease course. Up to 70% of patients experience pain in active disease, and up to half (20-50%) of patients will experience pain in remission.

Pain in IBD is widely recognised as a biopsychosocial construct, with visceral hypersensitivity, as well as depressive symptoms, anxiety, stress and fear avoidance correlating positively with IBD-pain. There is increasing understanding of the psychological interaction and need for psychological management within IBD. Psychological therapies such as Cognitive Behavioural Therapy (CBT) and acceptance and commitment therapy (ACT) have been used widely in other conditions, such as chronic pain, fatigue and irritable bowel syndrome (IBS).

Although neither ACT nor CBT have been used specifically for pain in IBD, ACT has become a regular therapy in the management of chronic pain and a large number of studies have found it to be effective, particularly in relation to improving functioning and decreasing distress, quality of life and physical wellbeing.

This study design is a crossover randomised controlled trial of ACT versus treatment-as-usual (TAU) in people with CD and chronic abdominal pain. The research team aim to assess the feasibility of ACT for reducing the impact of abdominal pain and its associated psychological burden in people with Crohn's disease (CD). The study will investigate the acceptability of ACT to people with CD and chronic pain, specifically testing issues of eligibility, recruitment, retention rates, patient experience and performance of proposed outcome measures. This will inform the design of a subsequent large multi-centre randomised controlled trial (RCT) with long-term follow-up.

Condition or disease Intervention/treatment Phase
Chronic Pain Crohn Disease Behavioral: Acceptance and commitment therapy (ACT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: Not possible die to study design
Primary Purpose: Treatment
Official Title: Managing Pain in People With Crohn's Disease: Feasibility Testing of an Acceptance and Commitment Group Therapy Intervention.
Estimated Study Start Date : January 11, 2023
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : February 2024

Arm Intervention/treatment
Experimental: Intervention arm
Patients randomised into Group 1 will begin the 8 week group first.
Behavioral: Acceptance and commitment therapy (ACT)
8 weekly 2 hour sessions of ACT group for CD patients with chronic pain. Manual available on request

Control crossover group
Patients randomised into Group 2 will act as the control for the first 8 weeks and then cross over into the intervention arm.
Behavioral: Acceptance and commitment therapy (ACT)
8 weekly 2 hour sessions of ACT group for CD patients with chronic pain. Manual available on request

Primary Outcome Measures :
  1. recruitment rate [ Time Frame: Through study completion, an average of 24 weeks ]
    Do patients want to be recruited/ randomised into the study

  2. retention rate [ Time Frame: Through study completion, an average of 24 weeks ]
    once randomised, do patients continue to engage in the study

  3. completion rate [ Time Frame: Through study completion, an average of 24 weeks ]
    How many patients "complete" the intervention (Attend 5 or more sessions)

Secondary Outcome Measures :
  1. Pain severity [ Time Frame: Screening, Baseline, Week 8, and 24 after randomisation ]
    the BPI severity questions assess pain at its "worst," "least," "average," (each over the last 24 hours) and "now" (current pain)

  2. The UK Inflammatory Bowel Disease Quality of Life Questionnaire [ Time Frame: Baseline, Week 8, and 24 after randomisation ]
    Quality of life: the UK IBDQ measures quality of life as measured in several domains: Emotional function, Bowel function, Social Function and Systemic function. Scale: None-> All/ almost all the time. Higher score means Higher level of impact from the condition.

  3. The Inflammatory Bowel Disease-Fatigue questionnaire [ Time Frame: Baseline, Week 8, and 24 after randomisation ]
    This was developed by two of the study investigators (WCD and CN) alongside people with IBD and provides the only validated fatigue scale specific to IBD. Scale 0= None of the time 4= All of the time. Higher score indicates higher levels of Fatigue.

  4. Depression, stress and anxiety: [ Time Frame: Baseline, Week 8, and 24 after randomisation ]
    The Depression Anxiety Stress Scales (DASS-21). Used previously in a study of ACT in IBD, this consists of three 7-item depression, anxiety, and stress survey tools Scale: 0=Did not apply to me at all. 3=Applied to me very much or most of the time. A higher score in each section indicates symptoms.

  5. Pain Acceptance [ Time Frame: Baseline, Week 8, and 24 after randomisation ]
    The Chronic Pain Acceptance Questionnaire (CPAQ-8) which measures acceptance of chronic pain; attempts to avoid or control pain; and the degree of engagement in activities. Scale: 0= Never True, 6= Always True

  6. IBD-Distress [ Time Frame: Baseline, Week 8, and 24 after randomisation ]
    The IBD-Distress Scale (IBD-DS), this 28-item scale (co-developed by WCD and CN) has good face and content validity and excellent internal consistency. Yes/ No , If Yes, Scale: 1= mildly distressing, 6=Highly Distressing. Higher scores indicates higher levels of distress.

  7. Treatment evaluation [ Time Frame: Post treatment Week 8, or 24 ]
    numerical ratings reflecting how interesting, successful and logical participants perceived the treatment to be on a scale of 0-10.

  8. Impairment in functioning:. [ Time Frame: Baseline, Week 8, and 24 after randomisation ]
    The Work and Social Adjustment Scale (WSAS), which provides a 5-question index of impairment in functioning attributable to an identified problem. Scale 0= Not at all, 8=Very severely.

  9. Pain Interference [ Time Frame: Screening, Baseline, Week 8, and 24 after randomisation ]
    the mean score on the pain interference questions on the BPI. This measures the degree to which pain has interfered with 7 daily activities (general activity, walking, work, mood, enjoyment of life, relations with others and sleep). This mean score will be used if more than 50% of the total items have been completed on a given administration. Scale: 0= Does not interfere, 10=Completely interferes

  10. SIMPLE INDEX OF CROHN'S DISEASE ACTIVITY (Harvey & Bradshaw 1980) [ Time Frame: Screening, Baseline, Week 8, and 24 after randomisation ]
    A) General Wellbeing: (Very well/slightly below par/poor/very poor/ Terrible), B) Abdominal pain (None, Mild, moderate, severe), C) Number of liquid stools per day:..... D) Abdomen feels Lumpy ( None, Dubious, Definite, Definite and tender), E) Complications please tick all that apply: Painful joints/ arthritis, Anal fissure/ fistula/ abcess, Mouth ulcers, Skin nodules or ulcers, Eye pain or inflammation (Red eyes), Liver Problems (e.g primary sclerosing cholangitis)

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Established diagnosis of CD according to clinical notes for a minimum of 6 months

Moderate pain, defined as mean score ≥4/10 on both pain severity and pain interference questions the Brief Pain Inventory (BPI) - a validated cut-off to define moderate pain

Duration of pain of at least 3 months

No changes to CD medication made for the previous 2 months

Exclusion Criteria:

  • Diagnosis of ulcerative colitis or indeterminate colitis

Known diagnosis of dementia/psychosis or expressing active suicidal ideation on clinical assessment

Currently undergoing other psychological therapy

Primary source of pain is non-abdominal

Non-fluency in verbal English

Pain is identified as a part of acute flare where immediate change in medical treatment is more appropriate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05418062

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Contact: Natalie Watson 0207848 3531 Natalie.1.watson@kcl.ac.uk
Contact: Dr Wladyslawa Czuber-Dochan 0207848 3531 wladzia.czuber-dochan@kcl.ac.uk

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United Kingdom
Natalie Watson Recruiting
London, United Kingdom, SE1 8WA
Contact: Natalie Watson       Natalie.1.watson@kcl.ac.uk   
Contact: Dr Wladyslawa Czuber-Dochan       wladzia.czuber-dochan@kcl.ac.uk   
Principal Investigator: Dr Wladyslawa Czuber-Dochan         
Principal Investigator: Dr Joel Mawdsley         
Principal Investigator: Dr Alexandra Kent         
Principal Investigator: Natalie Watson         
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
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Principal Investigator: Dr Wladyslawa Czuber-Dochan KCL
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT05418062    
Other Study ID Numbers: 314107
First Posted: June 14, 2022    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Chronic Pain
Neurologic Manifestations
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases