Group ACT for CD Pain- a Feasibility Study

NCT05418062 | Unknown

• 1 other identifier: 314107
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Crohn Disease

Outcome Measures

Primary Outcomes (3)

• recruitment rate

  Do patients want to be recruited/ randomised into the study

  Through study completion, an average of 24 weeks

• retention rate

  once randomised, do patients continue to engage in the study

  Through study completion, an average of 24 weeks

• completion rate

  How many patients "complete" the intervention (Attend 5 or more sessions)

  Through study completion, an average of 24 weeks

Secondary Outcomes (10)

• Pain severity

  Screening, Baseline, Week 8, and 24 after randomisation

• The UK Inflammatory Bowel Disease Quality of Life Questionnaire

  Baseline, Week 8, and 24 after randomisation

• The Inflammatory Bowel Disease-Fatigue questionnaire

  Baseline, Week 8, and 24 after randomisation

• Depression, stress and anxiety:

  Baseline, Week 8, and 24 after randomisation

• Pain Acceptance

  Baseline, Week 8, and 24 after randomisation

Study Arms (2)

Intervention arm

EXPERIMENTAL

Patients randomised into Group 1 will begin the 8 week group first.

Behavioral: Acceptance and commitment therapy (ACT)

Control crossover group

OTHER

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)

Interventions

Acceptance and commitment therapy (ACT) BEHAVIORAL

8 weekly 2 hour sessions of ACT group for CD patients with chronic pain. Manual available on request

Control crossover group; Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

Natalie Watson

London, SE1 8WA, United Kingdom

RECRUITING

Related Publications (1)

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Chronic Pain; Crohn Disease

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dr Wladyslawa Czuber-Dochan

  KCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie Watson

CONTACT

0207848 3531; Natalie.1.watson@kcl.ac.uk

Dr Wladyslawa Czuber-Dochan

CONTACT

0207848 3531; wladzia.czuber-dochan@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not possible die to study design
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: June 14, 2022
• Study Start: January 11, 2023
• Primary Completion: July 1, 2023
• Study Completion: February 1, 2024
• Last Updated: January 18, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)