Functional Chest PainNCT01284179
Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study
A study testing Home Hypnotherapy and Educational in people with Functional Chest Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The primary aim is to develop and test the feasibility of a standardized digital audio home-hypnotherapy (HHT) program for patients with refractory functional chest pain (FCP). The secondary aims of this study are: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Chest Pain
- What is being tested?
- Home Hypnotherapy and Educational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80, male or female.
- Patients must fulfill the Rome III criteria for Functional Chest Pain of Presumed Esophageal Origin for the previous 3 months (with symptom onset at least 6 months before diagnosis), including all of the following:
- Midline chest pain or discomfort that is not of burning quality
- Absence of evidence that gastroesophageal reflux is the cause of the symptom
- Absence of histopathology-based esophageal motility disorders
- Persistent symptoms despite a trial of antidepressant therapy, as defined by either:
Show all 10Show fewer
- chest pain despite at least a continuous 4-week trial of at least one antidepressant within the last 6 months; or
- intolerance of at least one antidepressant within the last 6 months.
- Negative cardiac evaluation (negative cardiac stress test or negative coronary angiogram)
- Negative gastrointestinal evaluation for cause of the pain, defined by absence of Los Angeles grade C or D erosive esophagitis on endoscopy, persistent chest pain on PPI therapy, and no association of chest pain with reflux episodes on an ambulatory pH or pH-impedance study, defined as a symptom index <50% or symptom association probability <95% for chest pain .
Who cannot join
- Severe co-morbid illness (cardiac, pulmonary, renal, hematologic, hepatic)
- Prior treatment with hypnosis/hypnotherapy for a medical condition
- Prior major thoracic surgery
- Prior diagnosis of or treatment for dissociative disorders, post-traumatic stress disorder, borderline personality disorder, or other psychiatric disorders that include psychotic features
- Pregnancy or planned pregnancy within the upcoming 3 months
- Inability or unwillingness to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
The primary aim is to develop and test the feasibility of a standardized digital audio home-hypnotherapy (HHT) program for patients with refractory functional chest pain (FCP).
The secondary aims of this study are:
- To obtain pilot data to assess the magnitude of the treatment effect of self-hypnosis in refractory FCP for an anticipated future, larger treatment trial;
- To determine the stability of the treatment effect of HHT in refractory FCP;
- To assess the relationship between response to HHT and psychological factors; and
- To assess the relationship between response to HHT and symptomatic dimensions of chest pain (severity, frequency, and duration).
- To assess the difference
Read the detailed description
Eligible patients with refractory FCP will be randomized to one of 2 arms: the active treatment group, who will receive the HHT program; or a control group. Patients in the active treatment group will receive the 12-week digital audio HHT program. This protocol consists of 7 sessions, each approximately 30-40 minutes, administered every 2 weeks, for a cumulative 12 weeks of treatment, along with a shorter (approximately 12 minute) session administered daily. Patients in the control group will receive a digital audio educational program. Subjects in both groups will be assessed at baseline, 4-6 weeks into treatment, at the end of the treatment, and 3 months after conclusion of the program. Global change in symptoms will be assessed with a 7-point Likert scale. Patients will be considered to respond if they have significant improvement on the Likert scale at the post-treatment visit. Patients will complete a chest pain symptom diary, the SCL-90 and the Coping Strategies Questionnaire-Catastrophizing subscale to assess psychological features, and the SF-36 as a measure of Health Related Quality of Life (HRQOL).
- Conditions
- Functional Chest Pain
- Being tested
- Home Hypnotherapy, Educational
- Keywords
- Functional Chest Pain, Functional GI Disorders, Home Hypnotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home HypnotherapyBehavioural
Each session contains the following elements: (1) trance induction consisting of narrowing the focus of attention and eye-closure, (2) trance deepening through imagery, guided dissociation from the here-and-now and graded suggestions of change in mental state, (3) vivid guided imagery that engages all the senses and implies improved health, well-being and a sense of strength and personal power, (4) therapeutic suggestions and imagery, both direct and indirect, for enhanced chest comfort, overall physical comfort and mental well-being and immunity to discomfort, that is suggested will last beyond termination of the session and become more noticeable and permanent over time, and (5) trance termination through direct suggestions and counting.
EducationalBehavioural
Educational recordings regarding FCP and FGIDs.
| Study group | Role | What they receive |
|---|---|---|
| Hypnotherapy | Experimental | Participants will be randomized to either the home hypnotherapy or educational group. The HHT protocol will consist of sequences of two different types of sessions, longer biweekly sessions (LS), each approximately 30-40 minutes in length, and shorter daily sessions (SS), approximately 12 minutes in length. On the first day of each sequence, the patient will listen to the appropriate LS. The patients will listen to the SS on a daily basis in between each LS. Every 2 weeks a new sequence will begin, for a total of 12 weeks of treatment. Receives: Behavioral: Home Hypnotherapy |
| Educational | Other | Participants will be randomized to receive either home hypnotherapy or an educational program. The control group will receive an educational digital audio program on MP3 players. These digital audio files will contain general information about FCP and FGIDs. These audio files will be similar to the intervention audio files in length. Patients will be instructed to begin listening on the day of randomization. Patients will be instructed to continue their other medical treatment for chest pain during the study. The control group will be assessed at the same times as the HHT group. Receives: Behavioral: Educational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global change in chest pain at the 12 weeks
To fulfill Rome III recommendations for the design of treatment trials for Functional Gastrointestinal Disorders (FGIDS),47 we will use a 7-point Likert scale to assess for global change in chest pain. At times V2, V3, and V4, patients will be asked the following question: "Compared to before starting this therapy, how would you rate your chest pain?" The following answers will be given as options: "much better" (+3), "somewhat better" (+2), "minimally better" (+1), "no change" (0), "minimally worse" (-1), "somewhat worse" (-2), "much worse" (-3).
Measured: 12 Weeks Post Treatment Start
Secondary outcomes (5)
Global change in chest pain at 4 weeks
To fulfill Rome III recommendations for the design of treatment trials for Functional Gastrointestinal Disorders (FGIDS),47 we will use a 7-point Likert scale to assess for global change in chest pain. At times V2, V3, and V4, patients will be asked the following question: "Compared to before starting this therapy, how would you rate your chest pain?" The following answers will be given as options: "much better" (+3), "somewhat better" (+2), "minimally better" (+1), "no change" (0), "minimally worse" (-1), "somewhat worse" (-2), "much worse" (-3).
Measured: 4 Weeks Post Treatment Start
Global change in chest pain at 6 weeks
To fulfill Rome III recommendations for the design of treatment trials for Functional Gastrointestinal Disorders (FGIDS),47 we will use a 7-point Likert scale to assess for global change in chest pain. At times V2, V3, and V4, patients will be asked the following question: "Compared to before starting this therapy, how would you rate your chest pain?" The following answers will be given as options: "much better" (+3), "somewhat better" (+2), "minimally better" (+1), "no change" (0), "minimally worse" (-1), "somewhat worse" (-2), "much worse" (-3).
Measured: 6 Weeks Post Treatment Start
Change in symptom score at 3 months
Assessed via daily chest pain diary
Measured: 12 Weeks Post Treatment Start
Change in psychometric score at 3 months
Assessed via SF-36 questionnaire and SCL-90 questionnaire.
Measured: 12 Weeks Post Treatment Start
Change in HRQOL scores at 3 months
Assessed via health related quality of life (HRQOL) questionnaire
Measured: 12 Weeks Post Treatment Start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Unable to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Chest PainStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Madanick, MD, University of North Carolina, Chapel Hill
- Investigators
- Ryan Madanick, MD, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284179
- Sponsor's protocol ID
- 09-0772
- Other IDs
- R24DK067674
- Status last verified
- Dec 2016
- First submitted
- 25 Jan 2011
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study
- ClinicalTrials.gov ID
- NCT01284179
- Acronym / sponsor ID
- 09-0772
- Conditions
- Functional Chest Pain
- Keywords
- Functional Chest Pain, Functional GI Disorders, Home Hypnotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jan 2011 (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 aim is to develop and test the feasibility of a standardized digital audio home-hypnotherapy (HHT) program for patients with refractory functional chest pain (FCP).
The secondary aims of this study are:
- To obtain pilot data to assess the magnitude of the treatment effect of self-hypnosis in refractory FCP for an anticipated future, larger treatment trial;
- To determine the stability of the treatment effect of HHT in refractory FCP;
- To assess the relationship between response to HHT and psychological factors; and
- To assess the relationship between response to HHT and symptomatic dimensions of chest pain (severity, frequency, and duration).
- To assess the difference
Detailed description
Eligible patients with refractory FCP will be randomized to one of 2 arms: the active treatment group, who will receive the HHT program; or a control group. Patients in the active treatment group will receive the 12-week digital audio HHT program. This protocol consists of 7 sessions, each approximately 30-40 minutes, administered every 2 weeks, for a cumulative 12 weeks of treatment, along with a shorter (approximately 12 minute) session administered daily. Patients in the control group will receive a digital audio educational program. Subjects in both groups will be assessed at baseline, 4-6 weeks into treatment, at the end of the treatment, and 3 months after conclusion of the program. Global change in symptoms will be assessed with a 7-point Likert scale. Patients will be considered to respond if they have significant improvement on the Likert scale at the post-treatment visit. Patients will complete a chest pain symptom diary, the SCL-90 and the Coping Strategies Questionnaire-Catastrophizing subscale to assess psychological features, and the SF-36 as a measure of Health Related Quality of Life (HRQOL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnotherapy | Experimental | Behavioral: Home HypnotherapyParticipants will be randomized to either the home hypnotherapy or educational group. The HHT protocol will consist of sequences of two different types of sessions, longer biweekly sessions (LS), each approximately 30-40 minutes in length, and shorter daily sessions (SS), approximately 12 minutes in length. On the first day of each sequence, the patient will listen to the appropriate LS. The patients will listen to the SS on a daily basis in between each LS. Every 2 weeks a new sequence will begin, for a total of 12 weeks of treatment. |
| Educational | Other | Behavioral: EducationalParticipants will be randomized to receive either home hypnotherapy or an educational program. The control group will receive an educational digital audio program on MP3 players. These digital audio files will contain general information about FCP and FGIDs. These audio files will be similar to the intervention audio files in length. Patients will be instructed to begin listening on the day of randomization. Patients will be instructed to continue their other medical treatment for chest pain during the study. The control group will be assessed at the same times as the HHT group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 to 80, male or female.
- Patients must fulfill the Rome III criteria for Functional Chest Pain of Presumed Esophageal Origin for the previous 3 months (with symptom onset at least 6 months before diagnosis), including all of the following:
- Persistent symptoms despite a trial of antidepressant therapy, as defined by either:
- Negative cardiac evaluation (negative cardiac stress test or negative coronary angiogram)
- Negative gastrointestinal evaluation for cause of the pain, defined by absence of Los Angeles grade C or D erosive esophagitis on endoscopy, persistent chest pain on PPI therapy, and no association of chest pain with reflux episodes on an ambulatory pH or pH-impedance study, defined as a symptom index <50% or symptom association probability <95% for chest pain .
Key exclusion criteria (6 listed)
- Severe co-morbid illness (cardiac, pulmonary, renal, hematologic, hepatic)
- Prior treatment with hypnosis/hypnotherapy for a medical condition
- Prior major thoracic surgery
- Prior diagnosis of or treatment for dissociative disorders, post-traumatic stress disorder, borderline personality disorder, or other psychiatric disorders that include psychotic features
- Pregnancy or planned pregnancy within the upcoming 3 months
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 |
|---|---|---|
| Home HypnotherapyEach session contains the following elements: (1) trance induction consisting of narrowing the focus of attention and eye-closure, (2) trance deepening through imagery, guided dissociation from the here-and-now and graded suggestions of change in mental state, (3) vivid guided imagery that engages all the senses and implies improved health, well-being and a sense of strength and personal power, (4) therapeutic suggestions and imagery, both direct and indirect, for enhanced chest comfort, overall physical comfort and mental well-being and immunity to discomfort, that is suggested will last beyond termination of the session and become more noticeable and permanent over time, and (5) trance termination through direct suggestions and counting. | Behavioural | Hypnotherapy |
| EducationalEducational recordings regarding FCP and FGIDs. | Behavioural | Educational |
Primary outcome
Global change in chest pain at the 12 weeks
Time frame: 12 Weeks Post Treatment Start
To fulfill Rome III recommendations for the design of treatment trials for Functional Gastrointestinal Disorders (FGIDS),47 we will use a 7-point Likert scale to assess for global change in chest pain. At times V2, V3, and V4, patients will be asked the following question: "Compared to before starting this therapy, how would you rate your chest pain?" The following answers will be given as options: "much better" (+3), "somewhat better" (+2), "minimally better" (+1), "no change" (0), "minimally worse" (-1), "somewhat worse" (-2), "much worse" (-3).
5 secondary outcomes
Global change in chest pain at 4 weeks
Time frame: 4 Weeks Post Treatment Start
Global change in chest pain at 6 weeks
Time frame: 6 Weeks Post Treatment Start
Change in symptom score at 3 months
Time frame: 12 Weeks Post Treatment Start
Change in psychometric score at 3 months
Time frame: 12 Weeks Post Treatment Start
Change in HRQOL scores at 3 months
Time frame: 12 Weeks Post Treatment Start
Results and safety
The study was stopped early (reason given: Unable to enroll). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
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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.
Ryan Madanick, MD principal investigator
UNC-Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Hypnotherapy and Educational in people with Functional Chest Pain, run by University of North Carolina, Chapel Hill 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 10 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: stopped early, as of the sponsor's last update on 20 Dec 2016. 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 was stopped early (reason given: Unable to enroll). Results are not available in the source record.
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?
Global change in chest pain at the 12 weeks (time frame: 12 Weeks Post Treatment Start). 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 20 Dec 2016.