Health TrialsbyHealthPanel

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

ConditionIrritable Bowel Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

The purpose of this study is to examine the feasibility, acceptability, preliminary effects, 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

IBS Diagnosis: Adult patients with an IBS diagnosis meeting standardized Rome IV diagnostic criteria.

Language and communication: English fluency and access to a phone.

Disqualifiers

Presence of inflammatory bowel disease or other structural/biochemical primary gastrointestinal illness that better explains IBS-like symptoms: As reported by the patient, their physician, and/or documented in the medical record.

Severe psychiatric illness: Current manic episode, psychosis, or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI) or Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND).

Cognitive impairment: Assessed using a six-item cognitive screen developed for research.

Presence of atrial fibrillation or a cardiac pacemaker, or daily use of beta blocking medication: As reported by the patient and/or documented in the medical record.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Positive Psychology (PP) Intervention

    Behavioral

    This is an adapted, optimized, phone-based, 9-week positive psychology (PP) intervention. Participants will complete 9 weekly phone sessions (30 minutes each) with a study interventionist in which they will review PP exercises that they have independently completed in between phone sessions. The PP exercises will be completed in a treatment manual that describes the PP exercise and provides space to write about the exercise and its effects, and to answer associated questions. A total of 9 sessions will be completed over the course of the program.

  • Educational Intervention

    Behavioral

    This is an educational intervention that will match the PP intervention in terms of both time and attention. Participants will complete 9 weekly phone sessions (30 minutes each) with a study interventionist in which they will review educational exercises that they have independently completed in between phone sessions. The exercises will be completed in a treatment manual that describes the exercise and provides space to write about the exercise and its effects, and to answer associated questions. A total of 9 sessions will be completed over the course of the program.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Positive Psychology (PP) InterventionExperimental treatment 1 intervention
Group B: Educational InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Intervention Sessions Completed by Participants

Feasibility will be measured by the proportion of intervention sessions completed by participants. The intervention will be considered feasible if at least 50% of participants complete at least 6/9 sessions.

Time frame
Post-intervention at 9 weeks
2

Ease of Weekly Exercises

Participants will provide ratings of ease after each weekly exercise, measured on a 10-point Likert scale (0=very difficult, 10=very easy).

Time frame
Weekly during intervention (weeks 1-8) and post-intervention (week 9)
3

Utility of Weekly Exercises

Participants will provide ratings of utility after each weekly exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful).

Time frame
Weekly during intervention (weeks 1-8) and post-intervention (week 9)

Secondary outcomes

1

Immediate Impact of the Exercises: Change in Optimism Ratings

Participants will provide ratings of optimism before and after each positive psychology exercise, measured on a 10-point Likert scale (0-10). Higher scores indicate higher levels of optimism.

Time frame
Weeks 1-9
2

Immediate Impact of the Exercises: Change in Happiness Ratings

Participants will provide ratings of happiness before and after each positive psychology exercise, measured on a 10-point Likert scale (0-10). Higher scores indicate higher levels of happiness.

Time frame
Weeks 1-9
3

Immediate Impact of the Exercises: Change in IBS Knowledge Ratings

Participants will provide ratings of knowledge about IBS before and after each educational exercise, measured on a 10-point Likert scale (0-10). Higher scores indicate higher levels of knowledge.

Time frame
Weeks 1-9
4

Change in IBS Symptom Severity

Measured by the IBS symptom severity score (IBS-SSS) (Range 0-500). This is a validated disease-specific instrument that measures IBS symptom severity. Higher scores indicate more severe symptoms.

Time frame
At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

Other outcomes

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
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