Stress Management for Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Stress Management for Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886027
• Other study ID #: WSU-022413B3E
• Status: Completed
• Phase: N/A
• First received: June 13, 2013
• Last updated: May 5, 2015
• Start date: June 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IBS symptom severity scale (IBS-SSS)		Change from baseline symptom severity at 1 month and 3 months	No
Secondary	McGill Pain Questionnaire, Short Form (SF-MPQ-2)		Change from baseline pain at 1 month and 3 months	No
Secondary	Bristol Stool Form Scale (BSFS)		Change from baseline stool form at 1 month and 3 months	No
Secondary	Irritable Bowel Syndrome, Quality of Life (IBS-QOL)		Change from baseline quality of life at 1 month and 3 months	No
Secondary	Positive and Negative Affect Scale (PANAS)		Change from baseline positive affect and negative affect at 1 month and 3 months	No
Secondary	Impact of Events Scale - Revised (IES-R)		Change from baseline impact of events at 1 month and 3 months	No
Secondary	Toronto Alexithymia Scale -20 (TAS-20)		Change from baseline alexithymia at 1 month and 3 months	No
Secondary	Rathus Assertiveness Schedule (RAS)		Change from baseline assertiveness at 1 month and 3 months	No
Secondary	Ambivalence over Emotional Expression Scale (AEQ)		Change from baseline ambivalence over emotional expression at 1 month and 3 months	No
Secondary	Emotional Approach Coping Scale (EAC)		Change from baseline emotional approach coping at 1 month and 3 months	No
Secondary	IBS self-efficacy questionnaire		Change from baseline self-efficacy at 1 month and 3 months	No
Secondary	Communicating Thoughts and Feelings Questionnaire		Change from baseline ability to communicate thoughts and feelings at 1 month and 3 months	No
Secondary	Clinical Global Impressions (CGI) Improvement Scale - IBS version		Change from baseline IBS symptoms at 1 month and 3 months	No
Secondary	Health care Utilization Scale		Change in health care utilization from baseline to 1-month and 3-month follow-ups	No
Secondary	Brief Symptom Inventory		Change in psychological symptoms from baseline to 1-month and 3-month follow-ups	No
Secondary	Early Trauma Inventory Self-Report Short Form		Change in Trauma reports from baseline to 1-month and 3-month follow-ups	No
Secondary	Experiences in Close Relationships Questionnaire		Change in attachment from baseline to 1-month and3-month follow-ups	No
Secondary	General Social Constraints Scale		Change in social constraints from baseline to 1-month and 3-month follow-ups	No
Secondary	Medication use		Change in medication use from baseline to 1-month and 3-month follow-ups	No