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Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study

This study is currently recruiting participants.
Verified December 2012 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ryan Madanick, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01284179
First received: January 25, 2011
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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

Condition Intervention
Functional Chest Pain
 Behavioral: Home Hypnotherapy
Behavioral: Educational

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain
U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Global change in chest pain at the 12 week mark. [ Time Frame: 12 Weeks Post Treatment Start ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypnotherapy
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
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
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
Educational recordings regarding FCP and FGIDs.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284179

Contacts
Contact: Susan Bream 919-966-7655 susan_bream@med.unc.edu

Locations
United States, North Carolina
University of North Carolina Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Susan Bream     919-966-7655     susan_bream@med.unc.edu    
Principal Investigator: Ryan Madanick            
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Ryan Madanick, MD UNC-Chapel Hill
  More Information

No publications provided

Responsible Party: Ryan Madanick, MD, Assistant Professor of Medicine Director, UNC Gastroenterology & Hepatology Fellowship Program, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01284179     History of Changes
Other Study ID Numbers: 09-0772, R24DK067674
Study First Received: January 25, 2011
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Functional Chest Pain
Functional GI Disorders
Home Hypnotherapy

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013