An interventional study of Home Hypnotherapy and Educational in Functional Chest Pain, sponsored by University of North Carolina, Chapel Hill. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-20.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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:
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).
381 studies on the registry are indexed under Chest Pain; 66 are open to participants now.
This study's enrollment of 8 is below the median of 143 across 201 interventional studies indexed under Chest Pain.
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Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
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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:
Exclusion Criteria:
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.
Behavioral: Home Hypnotherapy
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.
Behavioral: Educational
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.
Educational recordings regarding FCP and FGIDs.
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).
Time frame: 12 Weeks Post Treatment Start
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).
Time frame: 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).
Time frame: 6 Weeks Post Treatment Start
Change in symptom score at 3 months
Assessed via daily chest pain diary
Time frame: 12 Weeks Post Treatment Start
Change in psychometric score at 3 months
Assessed via SF-36 questionnaire and SCL-90 questionnaire.
Time frame: 12 Weeks Post Treatment Start
Change in HRQOL scores at 3 months
Assessed via health related quality of life (HRQOL) questionnaire
Time frame: 12 Weeks Post Treatment Start
This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill