Positive Psychology for Irritable Bowel Syndrome

Overseen By Emmett McGranaghan, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Severe psychiatric illness, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 9 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to examine the feasibility, acceptability, preliminary efficacy, and candidate gut-brain mechanisms of an optimized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS), entitled "WISH," compared to an educational control intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Positive Psychology Intervention safe for humans?

Psychological treatments, including Positive Psychology interventions, are generally considered safe for humans. They have been used effectively to reduce symptoms in conditions like irritable bowel syndrome without significant safety concerns. ^{1 2 3 4 5}

How does the Positive Psychology treatment differ from other treatments for Irritable Bowel Syndrome?

Positive Psychology treatment for Irritable Bowel Syndrome is unique because it focuses on enhancing mental well-being and positive emotions, rather than directly targeting physical symptoms. This approach aims to improve quality of life by reducing anxiety and depression, and promoting hope and optimism, which can indirectly help manage the condition. ^{6 7 8 9 10}

What data supports the effectiveness of the Positive Psychology treatment for Irritable Bowel Syndrome?

Research shows that psychological treatments, like Positive Psychology, can effectively reduce symptoms of irritable bowel syndrome. Studies found that these treatments help improve symptoms such as diarrhea and abdominal pain, especially in patients who haven't responded to standard medical treatments. ^{1 5 11 12 13}

Who Is on the Research Team?

Elizabeth N Madva, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with Irritable Bowel Syndrome (IBS). Participants should be interested in exploring non-medical treatments focused on mental well-being. Specific eligibility criteria are not provided, but typically include age range, symptom severity, and willingness to adhere to the study protocol.

Inclusion Criteria

English fluency and access to a phone

I have been diagnosed with IBS according to Rome IV criteria.

Exclusion Criteria

Severe psychiatric illness: Current manic episode, psychosis, or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI)

Cognitive impairment assessed using a six-item cognitive screen developed for research

I plan to begin a new mental health treatment during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 9-week, phone-delivered positive psychology (PP) intervention or an educational control intervention

9 weeks

Weekly phone sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person or virtual) at 3 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Educational Intervention
• Positive Psychology (PP) Intervention

Trial Overview The WISH 2.0 study is testing an optimized positive psychology intervention against an educational control intervention to see which one better improves the quality of life for IBS patients. It looks at how acceptable and effective these approaches are and their impact on gut-brain interactions.

How Is the Trial Designed?

Group I: Positive Psychology (PP) Intervention Experimental Treatment 1 Intervention

Participants will complete an adapted, optimized, phone-based, 9-week positive psychology (PP) intervention.

Group II: Educational Intervention Active Control 1 Intervention

Participants will complete a 9-week, phone-based educational intervention that matches the PP intervention in terms of both time and attention.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Cognitive-behavioral therapy (CBT) has been shown to significantly reduce the severity of irritable bowel syndrome (IBS) symptoms and improve quality of life, based on multiple randomized controlled trials.

Despite its proven efficacy, access to CBT for IBS is limited due to a shortage of trained therapists, highlighting the need for increased training and the development of telemedicine platforms to make this treatment more widely available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for patients with irritable bowel syndrome: current insights. Kinsinger, SW.[2022]

The case report highlights the successful integration of psychological support based on positive suggestions (PSBPS) with traditional treatment for a 36-year-old male patient with acute pancreatitis, demonstrating its potential as an effective adjunct therapy in critical care settings.

After implementing PSBPS, the patient showed significant improvements in cooperation, recovery motivation, and overall medical condition, leading to a full recovery and return to work within 10 months post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological support based on positive suggestions in the treatment of a critically ill ICU patient - A case report. Varga, K., Varga, Z., Fritúz, G.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Psychological treatments for irritable bowel syndrome: a systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A controlled trial of psychological treatment for the irritable bowel syndrome. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Controlled study of psychotherapy in irritable bowel syndrome. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Irritable bowel syndrome. [2005]

5. England pubmed.ncbi.nlm.nih.gov

Desperately seeking a cure: Treatment seeking and appraisal in irritable bowel syndrome. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for patients with irritable bowel syndrome: current insights. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy of psychological therapies for improving mental health and daily functioning in irritable bowel syndrome: A systematic review and meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Psychological treatments for irritable bowel syndrome: a comprehensive systematic review and meta-analysis. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

The efficacy and mechanism of positive psychological intervention on well-being for colostomy patients: a randomized controlled trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Are Positive Psychology Interventions Efficacious in Chronic Pain Treatment? A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The effect of positive psychology interventions on well-being and distress in clinical samples with psychiatric or somatic disorders: a systematic review and meta-analysis. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Effects of a Written Expression-Based Positive Psychological Intervention on the Psychological Status of Patients With Inflammatory Bowel Disease: A Randomized Controlled Trial. [2023]

13. Hungary pubmed.ncbi.nlm.nih.gov

Psychological support based on positive suggestions in the treatment of a critically ill ICU patient - A case report. [2021]