Impact of Stigma on Compliance to Medication in Functional Dyspepsia

Shanghai Jiao Tong University

Status: Unknown

Conditions: Functional Gastrointestinal Disorders; Adherence, Patient

Treatments: Behavioral: explanation when prescribing psychoactive medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT03625674

RJYYXHNK-003

Details and patient eligibility

About

To date, no study exists that evaluates whether functional dyspepsia patients experience stigma and how stigma may influence adherence. Thus, the investigators aim to evaluate the relationship between functional dyspepsia and stigma, and explore possible ways to improve treatment adherence.

Full description

Due to the functional but refractory nature of functional gastrointestinal diseases (FGIDs), large number of patients who suffer from FGIDs may not be able to fully understand their diagnosis, especially when they were told that they had no organic disease and their symptoms had a psychosomatic origin rather than a gastrointestinal one. Moreover, subjects with FGIDs have concerns and negative perceptions about medications, particularly in the presence of psychiatric comorbidity. Fearing of being labeled as insane or incapability, many patients with psychosomatic symptoms choose to conceal their illness to family, colleagues and doctors. These factors may affect willingness to initiate neuromodulator regimens and treatment adherence.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-70 years old;
• met the ROME IV criteria for FD;
• absence of abnormalities in physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), abdominal ultrasonography and upper GI endoscopy within 6 months;
• absence of H. pylori infection;
• Generalized Anxiety Disorder Scale (GAD-7) ≥ 1 or Patient Health Questionnaire Depression Scale (PHQ-9) ≥ 5

Exclusion criteria

• any evidence of organic digestive diseases;
• other FGIDs such as IBS;
• severe psychological symptoms with GAD-7 ≥ 11 or PHQ-9 ≥15;
• pregnancy or breastfeeding; recent myocardial infarction or cardiac arrhythmias;
• previous gastric surgery;
• use of PPIs, psychoactive drugs or other drugs that might affect gastric function within 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 4 patient groups

psychological and GI mechanisms

Other group

Description:

The patients in Group 1 were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Psychoactive medicine relieves FD symptoms through both psychological and GI mechanisms.

Treatment:

Behavioral: explanation when prescribing psychoactive medicine

psychological mechanism

Other group

Description:

The patients in Group 2 were told that: GI symptoms in FD are attributable to psychological mechanisms. Psychoactive medicine relieves FD symptoms through psychological mechanisms.

Treatment:

Behavioral: explanation when prescribing psychoactive medicine

GI mechanism

Other group

Description:

The patients in Group 3 were told that: GI symptoms in FD are attributable to GI mechanisms. Psychoactive medicine relieves FD symptoms through GI mechanisms.

Treatment:

Behavioral: explanation when prescribing psychoactive medicine

no explanation

Other group

Description:

The patients in Group 4 were not explained with the detailed mechanism of FD and psychoactive medicine

Treatment:

Behavioral: explanation when prescribing psychoactive medicine