Expectancy Challenge Intervention for Indigestion

(FAD Trial)

Overseen By Katherine A Berry, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Wyoming

Disqualifiers: Psychological treatment history, Reducing drinking

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

Compensation: Varies

Number of Visits: 2

75 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Food and alcohol disturbance expectancy challenge for indigestion?

Expectancy challenge interventions have been shown to reduce alcohol consumption and change alcohol-related expectations in various studies, suggesting they might help modify behaviors and beliefs related to alcohol and food, which could potentially benefit indigestion. ^{1 2 3 4 5}

How does the Food and alcohol disturbance expectancy challenge treatment differ from other treatments for indigestion?

The Food and alcohol disturbance expectancy challenge treatment is unique because it focuses on changing patients' expectations and beliefs about how food and alcohol affect their digestion, rather than directly targeting the physical symptoms. This approach is different from traditional treatments that often involve dietary changes, medications, or psychological therapies aimed at stress management. ^{6 7 8 9 10}

What is the purpose of this trial?

This study aims to create and test an intervention that helps college students re-evaluate their beliefs about food and alcohol disturbance (FAD) and, in turn, reduce how often they engage in it or intend to in the future. The main questions it aims to answer are: 1. Does the intervention help students have less positive beliefs about the effects of FAD and more negative beliefs about its effects? 2. If college students' beliefs about FAD change, does that lead them to engage in it less often or plan to do it less? 3. Will college students who engage in FAD sign up for the study, complete it, and feel that the intervention is helpful and valuable? Participants will take part in one 2-hour in-person laboratory-based study session where they will fill out surveys, learn about FAD, and engage in exercises designed to challenge their existing beliefs about it. They will also complete a follow-up survey online one month after their in-person study visit.

Research Team

Katherine A Berry, MS

Principal Investigator

University of Wyoming

Alison Looby, PhD

Principal Investigator

University of Wyoming

Eligibility Criteria

This trial is for college students who experience food and alcohol disturbance (FAD). Participants should be willing to attend a 2-hour in-person session and complete follow-up surveys. Specific inclusion or exclusion criteria are not provided, but typically these would relate to age, health status, and behaviors relevant to the study.

Inclusion Criteria

Must report engaging in FAD at least two times over the past month

Exclusion Criteria

Report hazardous drinking as indicated by the US Alcohol Use Disorder Identification Test

Report clinically significant eating disorder symptoms as indicated by the Eating Disorder Examination - Questionnaire7

Have a current or past history of receiving psychological treatment for their alcohol use and/or eating behaviors

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants engage in a 120-minute in-person session involving expectancy challenge intervention or psychoeducation

1 day

1 visit (in-person)

Follow-up

Participants complete an online follow-up survey to assess changes in FAD expectancies and behaviors

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• Food and alcohol disturbance expectancy challenge

Trial Overview The trial tests an intervention designed to change college students' beliefs about FAD. It involves filling out surveys, learning sessions, and belief-challenging exercises during a single laboratory visit with a one-month follow-up survey.

Participant Groups

Group I: FAD Expectancy Challenge Condition Experimental Treatment 1 Intervention

Participants in the experimental condition will be delivered the FAD expectancy challenge intervention.

Group II: Disordered Eating Psychoeducation Active Control 1 Intervention

Participants in the control condition will receive psychoeducation on disordered eating behaviors, with only a brief mention of FAD, and excluding any discussion of expectancies and consequences.

Who Is Running the Clinical Trial?

University of Wyoming

Lead Sponsor

Trials

20

Recruited

1,600+

References

1. England pubmed.ncbi.nlm.nih.gov

Single-session expectancy challenge with young heavy drinkers on holiday. [2019]

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

Expectations for reinforcement from alcohol use in a clinical sample. [2019]

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

Changes in alcohol expectancies and drinking behavior among treated problem drinkers. [2019]

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

Efficacy of expectancy challenge interventions to reduce college student drinking: a meta-analytic review. [2022]

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

Reinforcement expectancies and alcoholism treatment outcome after a one-year follow-up. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Life events stress in functional dyspepsia: a case control study. [2019]

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

The Interplay Between Stress and Fullness in Patients With Functional Dyspepsia and Healthy Controls: An Exploratory Experience Sampling Method Study. [2023]

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

Psychotherapy in functional dyspepsia. [2019]

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

Brief cognitive-behavioral treatment for avoidant/restrictive food intake disorder in the context of functional dyspepsia: Study protocol for a feasibility randomized controlled trial. [2023]

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

Treatment of Functional Dyspepsia. [2020]