Irritable Bowel SyndromeNCT03087799
Brief Behavioral Treatment for Sleep Problems in IBS Study
A study testing Brief Behavioral Treatment for Sleep in people with Irritable Bowel Syndrome and Sleep Disturbance, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Patients with Irritable Bowel Syndrome (IBS) often report more fatigue and sleep disturbances compared to their healthy counterparts and compared to patients with other GI disorders. This pilot study will evaluate the feasibility of a Brief Behavioral Treatment for Insomnia (BBT-I) in Irritable Bowel Syndrome. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Irritable Bowel Syndrome, Sleep Disturbance
- What is being tested?
- Brief Behavioral Treatment for Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2017to 8 Aug 2019
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-50
- Meet diagnostic criteria for IBS
- Stable medication for IBS for at least 1 month
- Stable medication for sleep for at least 1 month
- ISI cutoff score of 10 or higher
- Completes at least 5 out of 7 days of daily symptom and sleep diary during 1 week baseline
Who cannot join
- Medical history of significant head injury or other neurological disorder
- Pregnancy (self-reported)
- Post-menopause
- Major concomitant medical conditions
- Major psychiatric diagnosis with comorbid sleep problems
- Taking medications that might interfere with sleep
- Confirmed or suspected other untreated sleep disorder
- Active illicit drug use
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Brief Behavioral Treatment for Sleep Problems in Irritable Bowel Syndrome: a Pilot Study
Patients with Irritable Bowel Syndrome (IBS) often report more fatigue and sleep disturbances compared to their healthy counterparts and compared to patients with other GI disorders. This pilot study will evaluate the feasibility of a Brief Behavioral Treatment for Insomnia (BBT-I) in Irritable Bowel Syndrome. 40 participants will be recruited; 20 will receive 4 weeks of BBT and 20 will be assigned to a wait list control group (WLC). The primary aim of the current project is to assess feasibility of administering BBT-I to a sample of patients with IBS. Because behavioral sleep treatment has not yet been studied in IBS or any other GI population, this project will provide information about treatment adherence, recruitment, and effect sizes. Secondary aims include evaluating the impact of BBT-I on sleep quality and IBS symptom severity.
- Conditions
- Irritable Bowel Syndrome, Sleep Disturbance
- Being tested
- Brief Behavioral Treatment for Sleep
- Medical subject headings
- Irritable Bowel Syndrome, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Treatment for SleepBehavioural
The BBT arm will consist of 2 in-person treatment visits and 2 telephone check-in visits. Treatment will involve psychoeducation about sleep hygiene and stimulus control as well as sleep schedule modification and sleep restriction. The treatment manual is attached for clarification. This manual is used solely to guide clinical decision making and will not be provided to participants.
| Study group | Role | What they receive |
|---|---|---|
| Brief Behavioral Treatment for Sleep | Experimental | Not described Receives: Behavioral: Brief Behavioral Treatment for Sleep |
| Wait List Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Irritable Bowel Syndrome Severity Scoring System
A measure of IBS symptom severity
Measured: 5 weeks
Secondary outcomes (2)
Change in Insomnia Severity Index
A measure of insomnia
Measured: 5 weeks
Change in Pittsburgh Sleep Quality Index
A measure of sleep quality
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start3 Mar 2017
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Lembo, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087799
- Sponsor's protocol ID
- 2016P000440
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2017
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Behavioral Treatment for Sleep Problems in Irritable Bowel Syndrome: a Pilot Study
- ClinicalTrials.gov ID
- NCT03087799
- Acronym / sponsor ID
- 2016P000440
- Conditions
- Irritable Bowel Syndrome, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 23 Mar 2017 (actual)
- 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.
Patients with Irritable Bowel Syndrome (IBS) often report more fatigue and sleep disturbances compared to their healthy counterparts and compared to patients with other GI disorders. This pilot study will evaluate the feasibility of a Brief Behavioral Treatment for Insomnia (BBT-I) in Irritable Bowel Syndrome. 40 participants will be recruited; 20 will receive 4 weeks of BBT and 20 will be assigned to a wait list control group (WLC). The primary aim of the current project is to assess feasibility of administering BBT-I to a sample of patients with IBS. Because behavioral sleep treatment has not yet been studied in IBS or any other GI population, this project will provide information about treatment adherence, recruitment, and effect sizes. Secondary aims include evaluating the impact of BBT-I on sleep quality and IBS symptom severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Treatment for Sleep | Experimental | Behavioral: Brief Behavioral Treatment for Sleep |
| Wait List Control | No intervention | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 20-50
- Meet diagnostic criteria for IBS
- Stable medication for IBS for at least 1 month
- Stable medication for sleep for at least 1 month
- ISI cutoff score of 10 or higher
Key exclusion criteria (8 listed)
- Medical history of significant head injury or other neurological disorder
- Pregnancy (self-reported)
- Post-menopause
- Major concomitant medical conditions
- Major psychiatric diagnosis with comorbid sleep problems
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 |
|---|---|---|
| Brief Behavioral Treatment for SleepThe BBT arm will consist of 2 in-person treatment visits and 2 telephone check-in visits. Treatment will involve psychoeducation about sleep hygiene and stimulus control as well as sleep schedule modification and sleep restriction. The treatment manual is attached for clarification. This manual is used solely to guide clinical decision making and will not be provided to participants. | Behavioural | Brief Behavioral Treatment for Sleep |
Primary outcome
Change in Irritable Bowel Syndrome Severity Scoring System
Time frame: 5 weeks
A measure of IBS symptom severity
2 secondary outcomes
Change in Insomnia Severity Index
Time frame: 5 weeks
Change in Pittsburgh Sleep Quality Index
Time frame: 5 weeks
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 4 Mar 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Treatment for Sleep in people with Irritable Bowel Syndrome and Sleep Disturbance, run by Beth Israel Deaconess Medical Center 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 6 inclusion and 8 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 4 Mar 2020. 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?
Change in Irritable Bowel Syndrome Severity Scoring System (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2020.