Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study

NCT01284179 | Terminated DMC

• 2 other identifiers: 09-0772R24DK067674
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Functional Chest Pain

Keywords

Functional Chest Pain; Functional GI Disorders; Home Hypnotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Global change in chest pain at 4 weeks

  4 Weeks Post Treatment Start

• Global change in chest pain at 6 weeks

  6 Weeks Post Treatment Start

• Change in symptom score at 3 months

  12 Weeks Post Treatment Start

• Change in psychometric score at 3 months

  12 Weeks Post Treatment Start

• Change in HRQOL scores at 3 months

  12 Weeks Post Treatment Start

Study Arms (2)

Hypnotherapy

EXPERIMENTAL

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

Educational

OTHER

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

Interventions

Home Hypnotherapy BEHAVIORAL

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.

Hypnotherapy

Educational BEHAVIORAL

Educational recordings regarding FCP and FGIDs.

Educational

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Ryan Madanick, MD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine Director, UNC Gastroenterology & Hepatology Fellowship Program

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 26, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 20, 2016

Record last verified: 2016-12

Locations

US (1)