Stress Management for Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary goal of this study is to test the efficacy of emotional awareness and expression training (EAET), a novel emotional processing intervention that the investigators have developed, for people with IBS. In this randomized, controlled trial, the investigators will compare EAET to a standard intervention that teaches the conceptually opposite approach-relaxation training (RT)-and test how both of these interventions compare to a wait-list control condition. The investigators hypothesize that individuals in the EAET group will demonstrate greater improvement in their IBS symptom severity, psychological functioning, quality of life, and health care utilization at 4 and 12-week follow-up time points, compared to individuals in the wait-list control group. It is also expected that both of the active interventions (EAET and RT) will be more efficacious than the wait-list control condition.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients

NCT06145022

Irritable Bowel Syndrome

RECRUITING NA

A Six-month Study to Compare Outcome Differences and Visceral Response ... Irritable Bowel Syndrome

NCT00368771

Irritable Bowel Syndrome

COMPLETED NA

Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)

NCT01279382

Irritable Bowel Syndrome

COMPLETED NA

Emotion Focused Therapy in Irritable Bowel Syndrome Patients

NCT02657668

Functional Gastrointestinal Disorders

COMPLETED NA

Vagal Nerve Stimulation in Irritable Bowel Syndrome

NCT06090110

Irritable Bowel Syndrome

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Bowel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Emotional Awareness and Expression

Emotional awareness and expression training (EAET) is an emotional processing intervention.

Group Type EXPERIMENTAL

Emotional Awareness and Expression Training

Intervention Type BEHAVIORAL

An emotional processing intervention, which aims to reduce stress by helping patients become aware of, and express emotions related to stressful life experiences, as well as teaching patients how to relate to others differently.

Relaxation

Relaxation training will teach patients different relaxation training skills.

Group Type ACTIVE_COMPARATOR

Relaxation Training

Intervention Type BEHAVIORAL

Teaches patients different relaxation training skills to reduce their distress and discomfort (i.e., progressive muscle relaxation, applied relaxation, or guided imagery.

Wait-list control

Standard medical care until the 3-month follow-up is completed

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Emotional Awareness and Expression Training

An emotional processing intervention, which aims to reduce stress by helping patients become aware of, and express emotions related to stressful life experiences, as well as teaching patients how to relate to others differently.

Intervention Type BEHAVIORAL

Relaxation Training

Teaches patients different relaxation training skills to reduce their distress and discomfort (i.e., progressive muscle relaxation, applied relaxation, or guided imagery.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

To be eligible to participate, individuals must meet the Rome III criteria for IBS. That is, they must report that they have had:

* recurrent abdominal pain or discomfort, or
* a change in stool frequency or form,
* at least three days per month, in the last three months, and
* that they have been given this diagnosis by a physician. They must also report having pain and discomfort of at least two days per week at time of screening.

Exclusion Criteria

* Individuals who report having post-infectious IBS,
* organic gastrointestinal diseases (e.g., inflammatory bowel disease), immunodeficiency,
* a current psychotic disorder,
* drug or alcohol dependence within the past two years, and
* those who are unable to communicate in English will be excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No