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?

This trial explores a new method to assist individuals with irritable bowel syndrome (IBS) through positive psychology, which aims to enhance positive emotions and resilience. Participants will either join a 9-week positive psychology (PP) intervention program or an educational program, both conducted over the phone. The researchers aim to determine if positive psychology can improve IBS symptoms and understand its impact on the gut-brain connection. Suitable candidates have an IBS diagnosis, speak English fluently, and have phone access. As an unphased trial, this study provides a unique opportunity to investigate innovative approaches to managing IBS symptoms.

Will I have to stop taking my current medications?

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

What prior data suggests that these interventions are safe for IBS patients?

Research has shown that Positive Psychology (PP) treatments are generally safe. These treatments have been used to alleviate symptoms of irritable bowel syndrome (IBS) and aim to enhance well-being and quality of life. Studies have not identified any serious side effects, suggesting participants tolerate them well.

Previous studies comparing PP to other treatments reported no major safety concerns. Instead, participants experienced improvements in IBS symptoms and overall mental health. This suggests that PP treatments are a safe option for those considering similar trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Positive Psychology (PP) intervention for irritable bowel syndrome (IBS) because it takes a novel approach by focusing on mental well-being rather than directly targeting physical symptoms. Unlike standard IBS treatments, which often involve dietary changes, medications like antispasmodics, or cognitive behavioral therapy, this intervention uses positive psychology techniques to potentially enhance emotional resilience and reduce stress, both of which can exacerbate IBS symptoms. Additionally, the intervention is phone-based, making it more accessible and convenient for participants who might struggle with traditional in-person appointments. By emphasizing positivity and mental wellness, this approach could offer a refreshing, holistic complement to existing IBS management strategies.

What evidence suggests that this trial's treatments could be effective for IBS?

Research has shown that positive psychology activities can benefit people with irritable bowel syndrome (IBS). Past studies found that these activities can improve how individuals perceive their symptoms, even if the changes were not always statistically significant. Participants typically find these activities easy and helpful, rating them an average of 7 out of 10 for both ease and usefulness. In this trial, participants will be assigned to either a Positive Psychology (PP) Intervention or an Educational Intervention. By enhancing mental well-being, these treatments might also improve physical health. ^{1 6 7 8 9}

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40851355/

The WISH Proof-of-Concept Trial - PubMed

Compared to the WLC, the intervention led to promising but nonsignificant improvements in exploratory clinical outcomes including IBS symptom ...

2.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/nmo.70146?af=R

A Randomized Waitlist‐Controlled Trial of a Positive ...

The intervention was rated as easy to complete (mean = 7.2/10, 95% CI: [6.70, 7.75]) and subjectively helpful (mean = 7.6/10, 95% CI: [7.14, ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06866106?locStr=United+States&country=United+States

Well-being in IBS: Strengths and Happiness (WISH) 2.0

Compared to healthy populations, individuals with IBS have reduced positive psychological well-being, which in turn has been associated with impaired physical ...

4.

tandfonline.com

tandfonline.com/doi/full/10.1080/16506073.2023.2225745

Psychological treatments for irritable bowel syndrome

Effect sizes are presented so that larger (positive) values are indicative of more beneficial effects, such as a larger reduction in IBS ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1542356515017061

Short-term and Long-term Efficacy of Psychological ...

As a whole, psychological interventions included in this meta-analysis were found to significantly reduce GI symptoms in adults with IBS. This effect was medium ...

6.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2020.00286/full

Psychotherapeutic Interventions in Irritable Bowel Syndrome

The group with the extended psychological treatment showed a decrease of bowel symptoms and an increase of well-being, quality of life and control of disease ...

7.

withpower.com

withpower.com/trial/positive-psychology-for-irritable-bowel-syndrome-a8eb5

Positive Psychology for Irritable Bowel Syndrome

Psychological treatments, including Positive Psychology interventions, are generally considered safe for humans. They have been used effectively to reduce ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3468694/

The Irritable Bowel Syndrome Outcome Study (IBSOS)

After treatment, 62% of participants receiving MC-CBT described IBS symptoms as much or very much improved compared to 58% of patients receiving S-CBT and 7% on ...

9.

researchgate.net

researchgate.net/publication/394925433_A_Randomized_Waitlist-Controlled_Trial_of_a_Positive_Psychology_Intervention_for_Irritable_Bowel_Syndrome_The_WISH_Proof-of-Concept_Trial

A Randomized Waitlist‐Controlled Trial of a Positive ...

Compared to the WLC, the intervention led to promising but nonsignificant improvements in exploratory clinical outcomes including IBS symptom severity, IBS ...