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Completed

NCT Number: NCT01886027

Stress Management for Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University

Detroit, Michigan, 48067, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emotional Awareness and Expression Training

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 Training

Behavioral

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

Primary outcomes

  1. IBS symptom severity scale (IBS-SSS)

    Time frame: Change from baseline symptom severity at 1 month and 3 months

Secondary outcomes

  1. McGill Pain Questionnaire, Short Form (SF-MPQ-2)

    Time frame: Change from baseline pain at 1 month and 3 months

  2. Bristol Stool Form Scale (BSFS)

    Time frame: Change from baseline stool form at 1 month and 3 months

  3. Irritable Bowel Syndrome, Quality of Life (IBS-QOL)

    Time frame: Change from baseline quality of life at 1 month and 3 months

  4. Positive and Negative Affect Scale (PANAS)

    Time frame: Change from baseline positive affect and negative affect at 1 month and 3 months

  5. Impact of Events Scale - Revised (IES-R)

    Time frame: Change from baseline impact of events at 1 month and 3 months

  6. Toronto Alexithymia Scale -20 (TAS-20)

    Time frame: Change from baseline alexithymia at 1 month and 3 months

  7. Rathus Assertiveness Schedule (RAS)

    Time frame: Change from baseline assertiveness at 1 month and 3 months

  8. Ambivalence over Emotional Expression Scale (AEQ)

    Time frame: Change from baseline ambivalence over emotional expression at 1 month and 3 months

  9. Emotional Approach Coping Scale (EAC)

    Time frame: Change from baseline emotional approach coping at 1 month and 3 months

  10. IBS self-efficacy questionnaire

    Time frame: Change from baseline self-efficacy at 1 month and 3 months

  11. Communicating Thoughts and Feelings Questionnaire

    Time frame: Change from baseline ability to communicate thoughts and feelings at 1 month and 3 months

  12. Clinical Global Impressions (CGI) Improvement Scale - IBS version

    Time frame: Change from baseline IBS symptoms at 1 month and 3 months

  13. Health care Utilization Scale

    Time frame: Change in health care utilization from baseline to 1-month and 3-month follow-ups

  14. Brief Symptom Inventory

    Time frame: Change in psychological symptoms from baseline to 1-month and 3-month follow-ups

  15. Early Trauma Inventory Self-Report Short Form

    Time frame: Change in Trauma reports from baseline to 1-month and 3-month follow-ups

  16. Experiences in Close Relationships Questionnaire

    Time frame: Change in attachment from baseline to 1-month and3-month follow-ups

  17. General Social Constraints Scale

    Time frame: Change in social constraints from baseline to 1-month and 3-month follow-ups

  18. Medication use

    Time frame: Change in medication use from baseline to 1-month and 3-month follow-ups

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2013
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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