Stress Management for Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Behavioral: Emotional Awareness and Expression TrainingBehavioral: Relaxation Training
- Registration Number
- NCT01886027
- Lead Sponsor
- Wayne State University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Emotional Awareness and Expression Emotional Awareness and Expression Training Emotional awareness and expression training (EAET) is an emotional processing intervention. Relaxation Relaxation Training Relaxation training will teach patients different relaxation training skills.
- Primary Outcome Measures
Name Time Method IBS symptom severity scale (IBS-SSS) Change from baseline symptom severity at 1 month and 3 months
- Secondary Outcome Measures
Name Time Method Impact of Events Scale - Revised (IES-R) Change from baseline impact of events at 1 month and 3 months Toronto Alexithymia Scale -20 (TAS-20) Change from baseline alexithymia at 1 month and 3 months Bristol Stool Form Scale (BSFS) Change from baseline stool form at 1 month and 3 months Positive and Negative Affect Scale (PANAS) Change from baseline positive affect and negative affect at 1 month and 3 months Health care Utilization Scale Change in health care utilization from baseline to 1-month and 3-month follow-ups Brief Symptom Inventory Change in psychological symptoms from baseline to 1-month and 3-month follow-ups Experiences in Close Relationships Questionnaire Change in attachment from baseline to 1-month and3-month follow-ups General Social Constraints Scale Change in social constraints from baseline to 1-month and 3-month follow-ups McGill Pain Questionnaire, Short Form (SF-MPQ-2) Change from baseline pain at 1 month and 3 months Irritable Bowel Syndrome, Quality of Life (IBS-QOL) Change from baseline quality of life at 1 month and 3 months Rathus Assertiveness Schedule (RAS) Change from baseline assertiveness at 1 month and 3 months Ambivalence over Emotional Expression Scale (AEQ) Change from baseline ambivalence over emotional expression at 1 month and 3 months Clinical Global Impressions (CGI) Improvement Scale - IBS version Change from baseline IBS symptoms at 1 month and 3 months Communicating Thoughts and Feelings Questionnaire Change from baseline ability to communicate thoughts and feelings at 1 month and 3 months Medication use Change in medication use from baseline to 1-month and 3-month follow-ups IBS self-efficacy questionnaire Change from baseline self-efficacy at 1 month and 3 months Emotional Approach Coping Scale (EAC) Change from baseline emotional approach coping at 1 month and 3 months Early Trauma Inventory Self-Report Short Form Change in Trauma reports from baseline to 1-month and 3-month follow-ups
Trial Locations
- Locations (1)
Wayne State University
🇺🇸Detroit, Michigan, United States