Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study

Functional Chest Pain Clinical Trial

Official title:

Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01284179
• Other study ID #: 09-0772
• Secondary ID: R24DK067674
• Status: Terminated
• Phase: N/A
• First received: January 25, 2011
• Last updated: December 19, 2016
• Start date: February 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chest Pain
• Functional Chest Pain

Intervention

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
Educational recordings regarding FCP and FGIDs.

Locations

Country	Name	City	State
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global change in chest pain at the 12 weeks	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).	12 Weeks Post Treatment Start	No
Secondary	Global change in chest pain at 4 weeks	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).	4 Weeks Post Treatment Start	No
Secondary	Global change in chest pain at 6 weeks	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).	6 Weeks Post Treatment Start	No
Secondary	Change in symptom score at 3 months	Assessed via daily chest pain diary	12 Weeks Post Treatment Start	No
Secondary	Change in psychometric score at 3 months	Assessed via SF-36 questionnaire and SCL-90 questionnaire.	12 Weeks Post Treatment Start	No
Secondary	Change in HRQOL scores at 3 months	Assessed via health related quality of life (HRQOL) questionnaire	12 Weeks Post Treatment Start	No