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Effect of Psychological Intervention in Patients with Irritable Bowel Syndrome

An Open Label Randomised Controlled Trial to Study the Effect of CBT Based Intervention in Patients with Irritable Bowel Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046801
Enrollment
40
Registered
2022-10-26
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F45- Somatoform disorders

Interventions

Intervention1: CBT Based Intervention: Psychological Interventions including Psychoeducation, Relaxation Exercise, Activity Scheduling, Problem Solving Techniques Over four week period and a follow u

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age: 18-50 years Either gender Diagnosed with IBS (D/C/M) as per Rome IV criteria Duration of symptoms >= 12 months In treatment from gastroenterology for at least 3 months Refractory to pharmacological treatment (i.e., no improvement as reported by the patient on at least one pharmacological agent, and adequate dietary interventions) Has not received any structured psychological interventions Living in Delhi or NCR (feasible for weekly follow-up) Willing to participate in the study and provide written informed consent.

Exclusion criteria

Exclusion criteria: History of Psychosis/ Intellectual Disability / BPAD/ Dementia/ Cognitive impairment (using MINI screen) Current symptoms suggestive of severe depression or anxiety as evidenced by a PHQ 9 score > 15 or GAD 7 score >15 History of substance use disorder (except tobacco dependence) as per medical records. History of significant medical illness, as per medical records, hindering participation. History of COPD/ bronchial asthma or other respiratory conditions where deep breathing exercises may be contraindicated. Pregnancy. Not willing to participate

Design outcomes

Primary

MeasureTime frame
Effect of CBT based intervention on symptom severity in patients with irritable bowel syndrome using IBS-Symptom Severity ScoreTimepoint: Baseline, Week 4, Week 12—

Secondary

MeasureTime frame
effect of CBT based intervention on various psychological morbidity depression, anxiety, somatic distress and quality of life using IBS-GIS, IBS-QOL, PHQ-9, GAD-7, PHQ-15 Timepoint: Week 0, Week 4, Week 12—

Countries

India

Contacts

Public ContactDr Aayushi Sobhani

AIIMS, New Delhi

koushik.sinha.deb@gmail.com9868945171

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026