Clinical trial NCT05289089: Well-being in IBS: Strengths and Happiness (WISH)
Official title: The Well-being in IBS: Strengths and Happiness (WISH) Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2022-03-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial comparing PP intervention versus wait list control
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to examine the feasibility, acceptability, and preliminary efficacy of a customized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS) compared to a wait list control group.

Detailed description: Irritable bowel syndrome (IBS), a disorder of gut-brain interaction (DGBI; formerly known as functional gastrointestinal disorder) is characterized by abdominal pain and altered bowel habits, and conceptualized as resulting from complex interactions between biological, psychological, and social factors.

The treatment approach for IBS is multifaceted and focused on symptom reduction rather than cure. For mild or infrequent symptoms, lifestyle modification (e.g., diet and exercise), reassurance, and education about the disorder can at times be sufficient. For moderate to severe symptoms, a combination of pharmacotherapy and behavioral health interventions is often required. A growing body of evidence supports the use of behavioral health interventions to target the gut-brain axis in DGBI - aptly referred to as brain-gut behavior therapies (BGBT). Though highly effective, existing BGBT for IBS face important limitations including scalability and acceptability. There is also limited focus among existing BGBT on the promotion of positive psychological (PP) constructs (e.g., optimism), which are deficient in IBS, associated with fewer IBS symptoms, and associated with lower levels of distress in both clinical and non-clinical populations.

PP interventions have successfully been implemented in a variety of other chronic medical conditions to improve well-being, health-related quality of life, and health behavior engagement. PP interventions are highly acceptable and easily delivered remotely without extensive specialized training, which increases their scalability and reach.

As such, the investigators plan to do the following in this project:

1. Examine the feasibility and acceptability of a 9-week, telephone-delivered PP intervention adapted to the IBS population
2. Explore the impact of the PP intervention on psychological, behavioral, and health-related outcomes, compared to a wait list control group.

Eligibility criteria: Inclusion Criteria:

* IBS Diagnosis: Adult patients with an IBS diagnosis documented by the patient's primary care or GI clinician and meeting standardized ROME IV diagnostic criteria.
* Language and communication: English fluency and access to a telephone.

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.

Primary outcomes:
measure: Proportion of PP Sessions Completed by Participants
timeFrame: 9 weeks
Secondary outcomes:
measure: Ease of PP Exercises
timeFrame: Weeks 1-9
measure: Utility of PP exercises
timeFrame: Weeks 1-9
measure: Change in Positive Affect
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Optimism
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Depression
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Anxiety
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Gastrointestinal (GI) symptom specific anxiety
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Ability to Bounce Back from Stress
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Ability to Cope with Stress and Adversity
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Response to Pain
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Perceived Stress
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in IBS Health-related Quality of Life
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in IBS Symptom Severity
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Self-Reported Physical Activity
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Adherence to a Physician-Recommended Diet
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Adherence to Medications
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Avoidant and Restrictive Food Intake Disorder Symptoms
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in Eating Behaviors
timeFrame: Change in score from Baseline to 9 weeks
measure: Change in IBS diagnostic criteria
timeFrame: Change in score from Baseline to 9 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth Madva, M.D.
role: PRINCIPAL_INVESTIGATOR
References: