Clinical Trial: Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study

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 Summary: 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).
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Global change in chest pain at the 12 weeks [ Time Frame: 12 Weeks Post Treatment Start ]

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).


Original Primary Outcome: Global change in chest pain at the 12 week mark. [ Time Frame: 12 Weeks Post Treatment Start ]

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).


Current Secondary Outcome:

  • Global change in chest pain at 4 weeks [ Time Frame: 4 Weeks Post Treatment Start ]
    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 [ Time Frame: 6 Weeks Post Treatment Start ]
    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 [ Time Frame: 12 Weeks Post Treatment Start ]
    Assessed via daily chest pain diary
  • Change in psychometric score at 3 months [ Time Frame: 12 Weeks Post Treatment Start ]
    Assessed via SF-36 questionnaire and SCL-90 questionnaire.
  • Change in HRQOL scores at 3 months [ Time Frame: 12 Weeks Post Treatment Start ]
    Assessed via health related quality of life (HRQOL) questionnaire


Original Secondary Outcome: Global change in chest pain at the 4-6 week and 3 month follow-up marks, as well as change in symptom, psychometric, and HRQOL scores at each assessment [ Time Frame: 12 Weeks Post Treatment Start ]

In addition to the global chest pain assessment, measurements regarding symptoms, psychometric, and HRQOL will be obtained using a daily chest pain symptom diary, as well as questionnaires completed during each of 3 visits post treatment start(SF-36, SCL-90, and CSQ-C)


Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: January 25, 2011
Date Started: February 2011
Date Completion:
Last Updated: December 19, 2016
Last Verified: December 2016