Well-being in IBS: Strengths and Happiness (WISH)
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Behavioral: Positive Psychology Intervention
- Registration Number
- NCT05289089
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Positive Psychology Intervention Group Positive Psychology Intervention Participants will complete 9 weekly phone sessions with a study trainer and positive psychology exercises between phone sessions. Study trainers will review the positive psychology exercises with the participant on the phone each week. Participants will receive this intervention in addition to their treatment as usual. Wait list Control Group Positive Psychology Intervention After waiting for 9 weeks, participants will complete 9 weekly phone sessions with a study trainer and positive psychology exercises between phone sessions. Study trainers will review the positive psychology exercises with the participant on the phone each week. Participants will receive this intervention in addition to their treatment as usual.
- Primary Outcome Measures
Name Time Method Proportion of PP Sessions Completed by Participants 9 weeks Measured by proportion of PP sessions completed by participants in each group.
- Secondary Outcome Measures
Name Time Method Ease of PP Exercises Weeks 1-9 Participants will provide ratings of ease after each PP exercise, measured on a 10-point Likert scale (0=very difficult, 10=very easy). Weekly ratings will be averaged to provide an overall ease of the exercises.
Utility of PP exercises Weeks 1-9 Participants will provide ratings of utility after each PP exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings will be averaged to provide an overall utility score of the exercises.
Change in Positive Affect Change in score from Baseline to 9 weeks The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in Optimism Change in score from Baseline to 9 weeks Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of optimism. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in Anxiety Change in score from Baseline to 9 weeks The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of anxiety. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in Gastrointestinal (GI) symptom specific anxiety Change in score from Baseline to 9 weeks Measured by the Visceral Sensitivity Index (VSI) score, a validated self-report measure of anxiety specific to visceral sensations (Range: 0-75). Higher scores indicate higher levels of GI-specific anxiety. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in Ability to Bounce Back from Stress Change in score from Baseline to 9 weeks Measured by the Brief Resilience Scale (BRS) (Range: 6-30), a reliable 6-item measure of the ability to "bounce back" or recover from stress. Higher scores reflect greater bounce back resilience. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in Ability to Cope with Stress and Adversity Change in score from Baseline to 9 weeks Measured by the 25-item Connor-Davidson Resilience Scale (CD-RISC) (Range: 0-100), a reliable and validated measure of resilience, defined as the ability to cope with stress and adversity. Higher scores reflect greater resilience. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in Response to Pain Change in score from Baseline to 9 weeks Measured by the Pain Catastrophizing Scale (PCS), a widely used tool to assess cognitive and affective responses to pain (Range: 0-52). Higher scores indicate higher levels of pain-related anxiety. Change will be calculated by subtracting the scores at baseline from the scores at 9 weeks.
Change in IBS Symptom Severity Change in score from Baseline to 9 weeks Measured by the IBS symptom severity score (IBS-SSS) score (Range: 0-500), a validated disease-specific instrument measuring symptom severity. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in Self-Reported Physical Activity Change in score from Baseline to 9 weeks Measured by the self-report International Physical Activity Questionnaire (IPAQ). This measure assesses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in Adherence to a Physician-Recommended Diet Change in score from Baseline to 9 weeks Measured with a single question inquiring if the participant followed the diet with possible responses including: never, a quarter of the time, half of the time, three-quarters of the time, or always. A score of 0-4 (0=never, 4=always) will be applied. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in Depression Change in score from Baseline to 9 weeks The Hospital Anxiety and Depression Scale (HADS)-depression subscale will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of depression. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in Perceived Stress Change in score from Baseline to 9 weeks Measured by the Perceived Stress Scale (PSS) (Range: 0-40). Higher scores indicate higher perceived stress. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in IBS Health-related Quality of Life Change in score from Baseline to 9 weeks Measured by the IBS Quality of Life (IBS-QOL) score (Range: 0-100), a validated disease-specific instrument measuring quality of life. Higher scores indicate better IBS-specific quality of life. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in Adherence to Medications Change in score from Baseline to 9 weeks Measured with a 3-item questionnaire from the Heart and Soul study. Participants will be categorized as adherent (\>75% of the time) versus non-adherent (\<75% of the time), and this will be compared between baseline and 9 weeks.
Change in Eating Behaviors Change in score from Baseline to 9 weeks Measured by the Eating Disorder Examination Questionnaire 8 (EDE-Q8) (Range: 0-6), an 8-item questionnaire that assesses eating disorder symptoms over the past 28 days. Higher scores indicate higher levels of eating disordered symptoms. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Change in IBS diagnostic criteria Change in score from Baseline to 9 weeks Measured by the Rome IV Diagnostic Questionnaire - Irritable Bowel Syndrome (IBS) Module. This questionnaire provides inclusion criteria for IBS for clinical research studies. To meet criteria for IBS, participants must have the following for the past 3 months: (1) recurrent abdominal pain at least weekly; (2) pain associated with 2 or more of the following criteria: (a) related to defecation at least 30% of occasions; (b) associated with change in stool frequency at least 30% of occasions; (c) associated with change in stool form at least 30% of occasions; and (3) symptom onset at least 6 months prior to diagnosis.
Change in Avoidant and Restrictive Food Intake Disorder Symptoms Change in score from Baseline to 9 weeks Measured by the Nine Item Avoidant/Restrictive Food Intake Disorder screen (NIAS) (Range: 0-45), a validated tool to assess avoidant/restrictive eating patterns. Higher scores indicate higher levels of avoidant/restrictive eating patterns. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States