Back to resultsHome Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study
Primary Purpose
Functional Chest Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Hypnotherapy
Educational
Sponsored by
About this trial
This is an interventional treatment trial for Functional Chest Pain focused on measuring Functional Chest Pain, Functional GI Disorders, Home Hypnotherapy
Eligibility Criteria
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
Sites / Locations
- University of North Carolina Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Hypnotherapy
Educational
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
Change in symptom score at 3 months
Assessed via daily chest pain diary
Change in psychometric score at 3 months
Assessed via SF-36 questionnaire and SCL-90 questionnaire.
Change in HRQOL scores at 3 months
Assessed via health related quality of life (HRQOL) questionnaire
Full Information
NCT ID
NCT01284179
First Posted
January 25, 2011
Last Updated
December 19, 2016
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01284179
Brief Title
Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study
Official Title
Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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:
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Chest Pain
Keywords
Functional Chest Pain, Functional GI Disorders, Home Hypnotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypnotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home Hypnotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational
Intervention Description
Educational recordings regarding FCP and FGIDs.
Primary Outcome Measure Information:
Title
Global change in chest pain at the 12 weeks
Description
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).
Time Frame
12 Weeks Post Treatment Start
Secondary Outcome Measure Information:
Title
Global change in chest pain at 4 weeks
Description
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).
Time Frame
4 Weeks Post Treatment Start
Title
Global change in chest pain at 6 weeks
Description
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).
Time Frame
6 Weeks Post Treatment Start
Title
Change in symptom score at 3 months
Description
Assessed via daily chest pain diary
Time Frame
12 Weeks Post Treatment Start
Title
Change in psychometric score at 3 months
Description
Assessed via SF-36 questionnaire and SCL-90 questionnaire.
Time Frame
12 Weeks Post Treatment Start
Title
Change in HRQOL scores at 3 months
Description
Assessed via health related quality of life (HRQOL) questionnaire
Time Frame
12 Weeks Post Treatment Start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Madanick, MD
Organizational Affiliation
UNC-Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
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Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study
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