Trial Outcomes & Findings for Functional Dyspepsia Hypnosis (NCT NCT03884270)

NCT ID: NCT03884270

Last Updated: 2022-04-01

Results Overview

Feasibility will be calculated as the proportion of participants who complete the hypnotherapy treatment program in comparison to those who drop out before treatment is completed.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2022-04-01

Participant Flow

Participant milestones

Measure	Hypnotherapy 7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks) Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
Overall Study STARTED	23
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Functional Dyspepsia Hypnosis

Baseline characteristics by cohort

Measure	Hypnotherapy n=23 Participants 7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks) Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
Age, Continuous	38 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White/Caucasian	17 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black/African American	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic (any race)	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants
Relationship status Single	7 Participants n=5 Participants
Relationship status Committed relationship	6 Participants n=5 Participants
Relationship status Married	10 Participants n=5 Participants
Education High school	3 Participants n=5 Participants
Education Some college	3 Participants n=5 Participants
Education Technical school or associates degree	2 Participants n=5 Participants
Education Undergraduate degree	8 Participants n=5 Participants
Education Some graduate school	1 Participants n=5 Participants
Education Graduate degree	6 Participants n=5 Participants
Employment Full-time	15 Participants n=5 Participants
Employment Part-time	2 Participants n=5 Participants
Employment Not working	4 Participants n=5 Participants
Employment Retired	2 Participants n=5 Participants
Prior mental health diagnosis Yes	11 Participants n=5 Participants
Prior mental health diagnosis No	12 Participants n=5 Participants
Functional dyspepsia Rome Criteria met Postprandial distress syndrome only	6 Participants n=5 Participants
Functional dyspepsia Rome Criteria met Epigastric pain syndrome only	2 Participants n=5 Participants
Functional dyspepsia Rome Criteria met Postprandial distress syndrome and epigastric pain syndrome	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Participants enrolled in the study

Feasibility will be calculated as the proportion of participants who complete the hypnotherapy treatment program in comparison to those who drop out before treatment is completed.

Outcome measures

Measure	Hypnotherapy n=23 Participants 7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks) Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
Percent of Participants That Complete the Hypnotherapy Program	22 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Participants enrolled in the study and completed 3-month follow-up surveys.

Treatment satisfaction will be assessed with a single item at the end of treatment asking how satisfied they were overall with their assigned treatment (on a 7-point scale from "Extremely dissatisfied" to "Extremely satisfied")

Outcome measures

Measure	Hypnotherapy n=22 Participants 7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks) Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
Treatment Satisfaction Extremely dissatisfied	1 Participants
Treatment Satisfaction Very dissatisfied	0 Participants
Treatment Satisfaction Somewhat dissatisfied	0 Participants
Treatment Satisfaction Neutral	2 Participants
Treatment Satisfaction Somewhat satisfied	12 Participants
Treatment Satisfaction Very satisfied	4 Participants
Treatment Satisfaction Extremely satisfied	3 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Participants enrolled in the study and completed 3-month follow-up surveys.

At the end of treatment, patients were asked an open-ended question to obtain feedback on their experience using the web-based platform for treatment. They were asked to rate their difficulty using the web platform on a 7-point scale from "Extremely difficult" to "Extremely easy".

Outcome measures

Measure	Hypnotherapy n=22 Participants 7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks) Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
Satisfaction With Web Platform Extremely easy	17 Participants
Satisfaction With Web Platform Moderately easy	3 Participants
Satisfaction With Web Platform Somewhat easy	1 Participants
Satisfaction With Web Platform Neutral	1 Participants
Satisfaction With Web Platform Somewhat difficult	0 Participants
Satisfaction With Web Platform Moderately difficult	0 Participants
Satisfaction With Web Platform Extremely difficult	0 Participants

SECONDARY outcome

Timeframe: Baseline, 3-months

Population: Participants enrolled in the study.

The PAGI-SYM is a 20-item self-report measure of functional dyspepsia symptom severity. The scale consists of 6 subscales (heartburn/regurgitation, nausea/vomiting, postprandial fullness/early satiety, bloating, upper abdominal pain, and lower abdominal pain). Each item is measured by a 6-point Likert scale ranging from 0 (no complaints) to 5 (severe complaints). Subscale scores are calculated by taking the mean of the items in each subscale. The total score is calculated by taking the mean of the subscale scores. Total scores range from 0 to 5, with higher scores indicating worse symptoms. The PAGI-SYM total score was regressed on the fixed effect of time period in a linear mixed effects regression model that included random intercepts to account for within-participant correlation. Least square mean differences were calculated as 3-month follow-up minus baseline.

Outcome measures

Measure	Hypnotherapy n=23 Participants 7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks) Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
The Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Will be Used to Assess Changes in Functional Dyspepsia Symptoms	-0.82 score on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Participants enrolled in the study.

The NDI-SF is a 10-item self-report disease specific quality of life questionnaire. The scale consists of 5 sub-scales (tension/anxiety, interference with daily activities, disruption to regular eating/drinking, knowledge towards/control over disease, interference with work/study). Each item is measured by a 5-point Likert scale ranging from 0 (not applicable) to 4 (extremely). Individual items are aggregated to obtain a total score ranging from 0 to 100 with higher scores indicating greater impairment in quality of life. The NDI-SF score was regressed on the fixed effect of time period in a linear mixed effects regression model that included random intercepts to account for within-participant correlation. Least square mean differences were calculated as 3-month follow-up minus baseline.

Outcome measures

Measure	Hypnotherapy n=23 Participants 7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks) Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
The Short Form Nepean Dyspepsia Index (NDI-SF) Will be Used to Assess Changes in Quality of Life Related to Functional Dyspepsia.	-9.65 score on a scale Standard Error 1.75

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Participants enrolled in the study.

The VSI is a 15-item self-report questionnaire with responses ranging from 1 (strongly agree) to 6 (strongly disagree). The raw VSI score ranges from 0 (severe anxiety) to 75 (no anxiety). The VSI score was regressed on the fixed effect of time period in a linear mixed effects regression model that included random intercepts to account for within-participant correlation. Least square mean differences were calculated as 3-month follow-up minus baseline.

Outcome measures

Measure	Hypnotherapy n=23 Participants 7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks) Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
The Visceral Anxiety Index (VSI) Will be Used to Assess Changes in Gastrointestinal Specific Anxiety.	10.39 score on a scale Standard Error 2.73

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Participants enrolled in the study

The BSI is an 18-item self-report questionnaire with responses on a 5-point Likert scale, ranging from 0 (not bothered by a symptom at all) to 4 (extremely bothered). Three subscales are calculated (somatization, depression, and anxiety) and the subscales can be aggregated to calculate an overall global psychological distress score. The overall score and subscale scores are converted to T-scores (with a population mean of 50 and a standard deviation of 10). Higher T-scores indicate more psychological distress and T-scores ≥63 indicate clinically significant psychological distress. The BSI score was regressed on the fixed effect of time period in a linear mixed effects regression model that included random intercepts to account for within-participant correlation. Least square mean differences were calculated as 3-month follow-up minus baseline.

Outcome measures

Measure	Hypnotherapy n=23 Participants 7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks) Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
The Brief Symptom Inventory (BSI) Will be Used to Assess Changes in Psychological Distress.	-9.22 score on a scale Standard Error 1.34

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Participants enrolled in the study

At both baseline and end of treatment, patients will be asked to report the number of outpatient visits and procedures they have had within the last 3 months related to their functional dyspepsia symptoms

Outcome measures

Measure	Hypnotherapy n=23 Participants 7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks) Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment. Number of outpatient visits at baseline	2 number of events Interval 1.0 to 3.0
Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment. Number of outpatient visits at end of treatment	1 number of events Interval 0.0 to 2.0
Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment. Number of procedures at baseline	2 number of events Interval 1.0 to 2.0
Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment. Number of procedures at end of treatment	1 number of events Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Participants enrolled in the study

At baseline and end of treatment, patients will be asked to report any medications they are taking related to their functional dyspepsia symptoms.

Outcome measures

Measure	Hypnotherapy n=23 Participants 7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks) Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
Number of Medications Used for Functional Dyspepsia Medications taking at baseline	1 number of medications Interval 1.0 to 2.0
Number of Medications Used for Functional Dyspepsia Medications taking at end of treatment	1 number of medications Interval 1.0 to 2.0

Adverse Events

Hypnotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sarah Kinsinger

Loyola University Chicago

Phone: 708-216-0464

Email: sarah.kinsinger@lumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place