Rumination DisorderNCT03062696
A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD)
A study testing CBT-RD in people with Rumination Disorder, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The primary aim of this study is to pilot cognitive behavioral therapy (CBT-RD) for 10 individuals ages 10 and older who have rumination disorder Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Rumination Disorder
- What is being tested?
- CBT-RD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 May 2017to 1 Feb 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 10 or above
- Experience repeated regurgitation of food during or soon after eating, consistent with rumination disorder
- If applicable, have stable psychiatric medication for the past three months
Who cannot join
- Currently engage (in past three months) in any regular compensatory behaviors (e.g., self-induced vomiting, laxative/diuretic use)
- Current diagnosis of anorexia nervosa
- Acute suicide risk
- Are currently receiving psychological treatment for rumination disorder
- Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence)
- Current pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ani Keshishian
Boston, Massachusetts, 02114
Drexel University
Philadelphia, Pennsylvania, 19104
About this study
The primary aim of this study is to pilot cognitive behavioral therapy (CBT-RD) for 10 individuals ages 10 and older who have rumination disorder
Read the detailed description
Rumination disorder (RD; also known as "rumination syndrome") is characterized by the repeated regurgitation of food during or soon after eating, which typically occurs at least a few times per week, frequently daily, with subsequent re-chewing, re-swallowing, or spitting out of the regurgitated material. Diaphragmatic breathing is a widely used technique for rumination as a competing response to the abdominal wall contraction hypothesized to trigger regurgitation. However, the efficacy of diaphragmatic breathing remains unknown and has mainly been delivered simply through a one-session instruction with an occasional follow-up.
In the absence of evidence-based treatments for RD, Dr. Jennifer Thomas has contributed to the creation of a manualized treatment, Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD) informed by published case reports and currently in use at the Eating Disorders Clinical and Research Program (EDCRP) at Massachusetts General Hospital and the Psychological Services Center at Drexel University. CBT-RD targets the habitual contraction of the abdominal wall and preceding events through the use of habit reversal, using primarily diaphragmatic breathing as a competing response.
This study involves a phone screen to determine eligibility, followed by 5-8 sessions of CBT-RD (approximately 50 minutes each). A battery of questionnaires will be administered at pre-treatment, post-treatment, and 3-month follow-up intervals.
- Conditions
- Rumination Disorder
- Being tested
- CBT-RD
- Medical subject headings
- Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-RDBehavioural
5-8 sessions of cognitive behavioral therapy for rumination disorder (CBT-RD), held once per week in an outpatient setting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (CBT-RD) | Experimental | There is only one arm in this study - all participants will be in the same arm, as all participants will receive CBT-RD. There is no control group. Receives: Behavioral: CBT-RD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pica, Avoidant/Restrictive Food Intake Disorder, Rumination Disorder Interview (PARDI)
A semi-structured interview to assess pica, Avoidant/Restrictive Food Intake Disorder (ARFID), and/or rumination disorder diagnosis, severity, and symptoms. We will use the PARDI to assess frequency and severity of rumination behavior specifically.
Measured: Change from baseline to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start19 May 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rumination DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Drexel University
- Responsible party
- Principal investigator, Jennifer Thomas, Massachusetts General Hospital
- Investigators
- Jennifer J Thomas, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062696
- Sponsor's protocol ID
- 2017P000283
- Status last verified
- Jun 2019
- First submitted
- 20 Feb 2017
- Last updated
- 17 Jun 2019
- 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 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD)
- ClinicalTrials.gov ID
- NCT03062696
- Acronym / sponsor ID
- 2017P000283
- Conditions
- Rumination Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Drexel University
- Study start
- 19 May 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 23 Feb 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.
The primary aim of this study is to pilot cognitive behavioral therapy (CBT-RD) for 10 individuals ages 10 and older who have rumination disorder
Detailed description
Rumination disorder (RD; also known as "rumination syndrome") is characterized by the repeated regurgitation of food during or soon after eating, which typically occurs at least a few times per week, frequently daily, with subsequent re-chewing, re-swallowing, or spitting out of the regurgitated material. Diaphragmatic breathing is a widely used technique for rumination as a competing response to the abdominal wall contraction hypothesized to trigger regurgitation. However, the efficacy of diaphragmatic breathing remains unknown and has mainly been delivered simply through a one-session instruction with an occasional follow-up.
In the absence of evidence-based treatments for RD, Dr. Jennifer Thomas has contributed to the creation of a manualized treatment, Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD) informed by published case reports and currently in use at the Eating Disorders Clinical and Research Program (EDCRP) at Massachusetts General Hospital and the Psychological Services Center at Drexel University. CBT-RD targets the habitual contraction of the abdominal wall and preceding events through the use of habit reversal, using primarily diaphragmatic breathing as a competing response.
This study involves a phone screen to determine eligibility, followed by 5-8 sessions of CBT-RD (approximately 50 minutes each). A battery of questionnaires will be administered at pre-treatment, post-treatment, and 3-month follow-up intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention (CBT-RD) | Experimental | Behavioral: CBT-RDThere is only one arm in this study - all participants will be in the same arm, as all participants will receive CBT-RD. There is no control group. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 10 or above
- Experience repeated regurgitation of food during or soon after eating, consistent with rumination disorder
- If applicable, have stable psychiatric medication for the past three months
Key exclusion criteria (6 listed)
- Currently engage (in past three months) in any regular compensatory behaviors (e.g., self-induced vomiting, laxative/diuretic use)
- Current diagnosis of anorexia nervosa
- Acute suicide risk
- Are currently receiving psychological treatment for rumination disorder
- Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence)
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 |
|---|---|---|
| CBT-RD5-8 sessions of cognitive behavioral therapy for rumination disorder (CBT-RD), held once per week in an outpatient setting. | Behavioural | Intervention (CBT-RD) |
Primary outcome
Pica, Avoidant/Restrictive Food Intake Disorder, Rumination Disorder Interview (PARDI)
Time frame: Change from baseline to 3-month follow-up
A semi-structured interview to assess pica, Avoidant/Restrictive Food Intake Disorder (ARFID), and/or rumination disorder diagnosis, severity, and symptoms. We will use the PARDI to assess frequency and severity of rumination behavior specifically.
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 17 Jun 2019.
- 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.
Jennifer J Thomas, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-RD in people with Rumination Disorder, run by Massachusetts General Hospital at 2 sites 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 3 inclusion and 6 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 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Pica, Avoidant/Restrictive Food Intake Disorder, Rumination Disorder Interview (PARDI) (time frame: Change from baseline to 3-month follow-up). 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 17 Jun 2019.