Clinical trial NCT01284179: 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
Overall status: TERMINATED
Phase: NA
Conditions: Functional Chest Pain
Keywords: Functional Chest Pain
Functional GI Disorders
Home Hypnotherapy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-01-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. 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;
2. To determine the stability of the treatment effect of HHT in refractory FCP;
3. To assess the relationship between response to HHT and psychological factors; and
4. To assess the relationship between response to HHT and symptomatic dimensions of chest pain (severity, frequency, and duration).
5. 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).

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

Primary outcomes:
measure: Global change in chest pain at the 12 weeks
timeFrame: 12 Weeks Post Treatment Start
Secondary outcomes:
measure: Global change in chest pain at 4 weeks
timeFrame: 4 Weeks Post Treatment Start
measure: Global change in chest pain at 6 weeks
timeFrame: 6 Weeks Post Treatment Start
measure: Change in symptom score at 3 months
timeFrame: 12 Weeks Post Treatment Start
measure: Change in psychometric score at 3 months
timeFrame: 12 Weeks Post Treatment Start
measure: Change in HRQOL scores at 3 months
timeFrame: 12 Weeks Post Treatment Start
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Ryan Madanick, MD
role: PRINCIPAL_INVESTIGATOR
References: