Irritable Bowel SyndromeNCT01886027
Stress Management for Irritable Bowel Syndrome
A study testing Emotional Awareness and Expression Training and Relaxation Training in people with Irritable Bowel Syndrome, run by Wayne State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Emotional Awareness and Expression Training and Relaxation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Emotional Awareness and Expression Training, Relaxation Training
- Keywords
- IBS, Relaxation, Emotional exposure, Emotional Processing
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Awareness and Expression TrainingBehavioural
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 TrainingBehavioural
Teaches patients different relaxation training skills to reduce their distress and discomfort (i.e., progressive muscle relaxation, applied relaxation, or guided imagery.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Awareness and Expression | Experimental | Emotional awareness and expression training (EAET) is an emotional processing intervention. Receives: Behavioral: Emotional Awareness and Expression Training |
| Relaxation | Active comparator | Relaxation training will teach patients different relaxation training skills. Receives: Behavioral: Relaxation Training |
| Wait-list control | No intervention | Standard medical care until the 3-month follow-up is completed |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS symptom severity scale (IBS-SSS)
Measured: Change from baseline symptom severity at 1 month and 3 months
Secondary outcomes (18)
McGill Pain Questionnaire, Short Form (SF-MPQ-2)
Measured: Change from baseline pain at 1 month and 3 months
Bristol Stool Form Scale (BSFS)
Measured: Change from baseline stool form at 1 month and 3 months
Irritable Bowel Syndrome, Quality of Life (IBS-QOL)
Measured: Change from baseline quality of life at 1 month and 3 months
Positive and Negative Affect Scale (PANAS)
Measured: Change from baseline positive affect and negative affect at 1 month and 3 months
Impact of Events Scale - Revised (IES-R)
Measured: Change from baseline impact of events at 1 month and 3 months
Toronto Alexithymia Scale -20 (TAS-20)
Measured: Change from baseline alexithymia at 1 month and 3 months
Rathus Assertiveness Schedule (RAS)
Measured: Change from baseline assertiveness at 1 month and 3 months
Ambivalence over Emotional Expression Scale (AEQ)
Measured: Change from baseline ambivalence over emotional expression at 1 month and 3 months
Emotional Approach Coping Scale (EAC)
Measured: Change from baseline emotional approach coping at 1 month and 3 months
IBS self-efficacy questionnaire
Measured: Change from baseline self-efficacy at 1 month and 3 months
Communicating Thoughts and Feelings Questionnaire
Measured: Change from baseline ability to communicate thoughts and feelings at 1 month and 3 months
Clinical Global Impressions (CGI) Improvement Scale - IBS version
Measured: Change from baseline IBS symptoms at 1 month and 3 months
Health care Utilization Scale
Measured: Change in health care utilization from baseline to 1-month and 3-month follow-ups
Brief Symptom Inventory
Measured: Change in psychological symptoms from baseline to 1-month and 3-month follow-ups
Early Trauma Inventory Self-Report Short Form
Measured: Change in Trauma reports from baseline to 1-month and 3-month follow-ups
Experiences in Close Relationships Questionnaire
Measured: Change in attachment from baseline to 1-month and3-month follow-ups
General Social Constraints Scale
Measured: Change in social constraints from baseline to 1-month and 3-month follow-ups
Medication use
Measured: Change in medication use from baseline to 1-month and 3-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark A. Lumley, Wayne State University
- Investigators
- Mark A. Lumley, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886027
- Sponsor's protocol ID
- WSU-022413B3E
- Status last verified
- May 2015
- First submitted
- 13 Jun 2013
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Thakur ER, Holmes HJ, Lockhart NA, Carty JN, Ziadni MS, Doherty HK, Lackner JM, Schubiner H, Lumley MA. Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial. Neurogastroenterol Motil. 2017 Dec;29(12):10.1111/nmo.13143. doi: 10.1111/nmo.13143. Epub 2017 Jun 22.
PubMed 28643436
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01886027
- Acronym / sponsor ID
- WSU-022413B3E
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, Relaxation, Emotional exposure, Emotional Processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Emotional Awareness and Expression | Experimental | Behavioral: Emotional Awareness and Expression TrainingEmotional awareness and expression training (EAET) is an emotional processing intervention. |
| Relaxation | Active comparator | Behavioral: Relaxation TrainingRelaxation training will teach patients different relaxation training skills. |
| Wait-list control | No intervention | –Standard medical care until the 3-month follow-up is completed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Awareness and Expression TrainingAn 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. | Behavioural | Emotional Awareness and Expression |
| Relaxation TrainingTeaches patients different relaxation training skills to reduce their distress and discomfort (i.e., progressive muscle relaxation, applied relaxation, or guided imagery. | Behavioural | Relaxation |
Primary outcome
IBS symptom severity scale (IBS-SSS)
Time frame: Change from baseline symptom severity at 1 month and 3 months
18 secondary outcomes
McGill Pain Questionnaire, Short Form (SF-MPQ-2)
Time frame: Change from baseline pain at 1 month and 3 months
Bristol Stool Form Scale (BSFS)
Time frame: Change from baseline stool form at 1 month and 3 months
Irritable Bowel Syndrome, Quality of Life (IBS-QOL)
Time frame: Change from baseline quality of life at 1 month and 3 months
Positive and Negative Affect Scale (PANAS)
Time frame: Change from baseline positive affect and negative affect at 1 month and 3 months
Impact of Events Scale - Revised (IES-R)
Time frame: Change from baseline impact of events at 1 month and 3 months
Toronto Alexithymia Scale -20 (TAS-20)
Time frame: Change from baseline alexithymia at 1 month and 3 months
Rathus Assertiveness Schedule (RAS)
Time frame: Change from baseline assertiveness at 1 month and 3 months
Ambivalence over Emotional Expression Scale (AEQ)
Time frame: Change from baseline ambivalence over emotional expression at 1 month and 3 months
Emotional Approach Coping Scale (EAC)
Time frame: Change from baseline emotional approach coping at 1 month and 3 months
IBS self-efficacy questionnaire
Time frame: Change from baseline self-efficacy at 1 month and 3 months
Communicating Thoughts and Feelings Questionnaire
Time frame: Change from baseline ability to communicate thoughts and feelings at 1 month and 3 months
Clinical Global Impressions (CGI) Improvement Scale - IBS version
Time frame: Change from baseline IBS symptoms at 1 month and 3 months
Health care Utilization Scale
Time frame: Change in health care utilization from baseline to 1-month and 3-month follow-ups
Brief Symptom Inventory
Time frame: Change in psychological symptoms from baseline to 1-month and 3-month follow-ups
Early Trauma Inventory Self-Report Short Form
Time frame: Change in Trauma reports from baseline to 1-month and 3-month follow-ups
Experiences in Close Relationships Questionnaire
Time frame: Change in attachment from baseline to 1-month and3-month follow-ups
General Social Constraints Scale
Time frame: Change in social constraints from baseline to 1-month and 3-month follow-ups
Medication use
Time frame: Change in medication use from baseline to 1-month and 3-month follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Derived from this study: PubMed 28643436Thakur ER, Holmes HJ, Lockhart NA, Carty JN, Ziadni MS, Doherty HK, Lackner JM, Schubiner H, Lumley MA. Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial. Neurogastroenterol Motil. 2017 Dec;29(12):10.1111/nmo.13143. doi: 10.1111/nmo.13143. Epub 2017 Jun 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A. Lumley, Ph.D. principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Awareness and Expression Training and Relaxation Training in people with Irritable Bowel Syndrome, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS symptom severity scale (IBS-SSS) (time frame: Change from baseline symptom severity at 1 month and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01886027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.