- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01284179
Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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:
- 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 .
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypnotherapy
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.
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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.
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Other: Educational
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.
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Educational recordings regarding FCP and FGIDs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global change in chest pain at the 12 weeks
Time Frame: 12 Weeks Post Treatment Start
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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).
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12 Weeks Post Treatment Start
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global change in chest pain at 4 weeks
Time Frame: 4 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).
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4 Weeks Post Treatment Start
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Global change in chest pain at 6 weeks
Time Frame: 6 Weeks Post Treatment Start
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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).
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6 Weeks Post Treatment Start
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Change in symptom score at 3 months
Time Frame: 12 Weeks Post Treatment Start
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Assessed via daily chest pain diary
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12 Weeks Post Treatment Start
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Change in psychometric score at 3 months
Time Frame: 12 Weeks Post Treatment Start
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Assessed via SF-36 questionnaire and SCL-90 questionnaire.
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12 Weeks Post Treatment Start
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Change in HRQOL scores at 3 months
Time Frame: 12 Weeks Post Treatment Start
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Assessed via health related quality of life (HRQOL) questionnaire
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12 Weeks Post Treatment Start
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Collaborators and Investigators
Investigators
- Principal Investigator: Ryan Madanick, MD, UNC-Chapel Hill
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-0772
- R24DK067674 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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