Stress Management for Irritable Bowel Syndrome

Wayne State University

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: Emotional Awareness and Expression Training; Behavioral: Relaxation Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01886027

WSU-022413B3E

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 3 patient groups

Emotional Awareness and Expression

Experimental group

Description:

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

Treatment:

Behavioral: Emotional Awareness and Expression Training

Relaxation

Active Comparator group

Description:

Relaxation training will teach patients different relaxation training skills.

Treatment:

Behavioral: Relaxation Training

Wait-list control

No Intervention group

Description:

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