Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study

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).

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