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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
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).
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Start Date
February 1, 2011
Primary Completion Date
December 1, 2015
Completion Date
December 1, 2015
Last Updated
December 20, 2016
8
ACTUAL participants
Home Hypnotherapy
BEHAVIORAL
Educational
BEHAVIORAL
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborators
Data Source & Attribution
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