NCT07838324招募中不适用
A Pilot Investigation of Pain Reprocessing Therapy for Functional Dyspepsia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Average Gastroparesis Cardinal Symptom Index Score
研究概览
简要总结
The purpose of this research is to test whether pain processing therapy, a novel psychological intervention that emphasizes exposure-based techniques, can reduce digestive symptom severity and improve functioning in people with functional dyspepsia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilled Rome V diagnostic criteria for functional dyspepsia postprandial distress syndrome subtype, with or without epigastric pain syndrome.
- •A total score of at least 3 on the Gastroparesis Cardinal Symptom Index (GCSI) indicating symptom severity to be moderate or higher.
- •Normal gastric emptying as confirmed by standard gastric emptying testing (if such a testing was clinically done).
- •Upper endoscopy negative to rule out structural or organic etiologies for GI symptoms (within last 1 year).
- •Fluent in English language.
- •Able to provide informed consent and comply with study procedures.
排除标准
- •Evidence of organic gastrointestinal disease or surgical history that could explain participant symptoms (e.g., peptic ulcer disease, celiac disease, inflammatory bowel disease, eosinophilic gastritis or eosinophilic esophagitis, malignancy).
- •Current or recent (within the past 12 months) eating disorder such as anorexia nervosa or bulimia nervosa. Historical eating disorder diagnosis may also be exclusionary if residual disordered eating patterns, fear of weight gain, or food-related body image concerns are judged by the investigator to potentially confound symptom interpretation or participation.
- •Underweight BMI (<17 kg/m²) or evidence of clinically significant unintentional weight loss (>25% body weight in 6 months).
- •Current use of enteral or parenteral nutrition for >50% of caloric needs and/or participant unwillingness to reduce use of enteral or parenteral nutrition at the time of study enrollment.
- •History of developmental or intellectual disability, current cognitive impairment that would preclude participation, or other neurological illness impairing cognitive functioning.
- •Active suicidal ideation, suicide attempt within the past 12 months, severe psychiatric illness, severe depressive symptomatology, acute distress, or other symptomatology that, in the investigator's judgment, would necessitate a different level of psychiatric care and/or prevent full engagement in psychological intervention sessions or adherence to study procedures.
- •Medical disability or any unstable systemic illness (e.g., decompensated hepatic, cardiac, renal, or neurological disease) that could interfere with participation, comprehension, or safety in psychological intervention sessions.
- •Current daily cannabis use (inhaled, edible, or medical). Other substance use or misuse of prescription medications may also be exclusionary if substance use patterns are judged by the investigator to potentially confound symptom interpretation or participation.
- •Current pregnancy or lactation.
- •Inability or unwillingness of individual to give informed consent.
- •Non-fluent in English, or any condition that would limit compliance or follow-up.
研究组 & 干预措施
Pain Reprocessing Therapy
Experimental
Participants will receive eight weekly pain reprocessing therapy sessions. Session 1 will occur at Week 0, and sessions will continue weekly through Session 8 at Week 7.
The first and last sessions will be delivered in person when possible to coordinate with baseline and post-treatment physiologic testing, and interim sessions will be completed via telehealth.
干预措施: Pain Reprocessing Therapy (Behavioral)
结局指标
主要结局
Change in Average Gastroparesis Cardinal Symptom Index Score
时间窗: Baseline, Week 7
Change in average Gastroparesis Cardinal Symptom Index score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire will be assessed. The Gastroparesis Cardinal Symptom Index assesses upper gastrointestinal symptom severity; higher scores indicate greater symptom severity.
次要结局
- Change in Maximum Tolerated Volume During Nutrient Drink Test(Baseline, Week 7)
- Change in Symptom Ratings During Nutrient Drink Test(Baseline, Week 7)
- Change in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Score(Baseline, Week 7)
- Mean Change From Baseline in Gastrointestinal Unhelpful Thinking Scale Pain Catastrophizing Subscale Score(Baseline, Week 7)
- Mean Change From Baseline in Visceral Sensitivity Index Score(Baseline, Week 7)
- Mean Change From Baseline in Fear of Food Questionnaire Score(Baseline, Week 7)
- Mean Change From Baseline in Nine Item ARFID Screen Fear Subscale Score(Baseline, Week 7)
- Mean Change From Baseline in PROMIS Physical Function Score(Baseline, Week 7)
- Mean Change From Baseline in PROMIS Anxiety Score(Baseline, Week 7)
- Mean Change From Baseline in PROMIS Depression Score(Baseline, Week 7)
- Mean Change From Baseline in PROMIS Fatigue Score(Baseline, Week 7)
- Mean Change From Baseline in PROMIS Sleep Disturbance Score(Baseline, Week 7)
- Mean Change From Baseline in PROMIS Ability to Participate in Social Roles and Activities Score(Baseline, Week 7)
- Mean Change From Baseline in PROMIS Pain Interference Score(Baseline, Week 7)
- Mean Change From Baseline in PROMIS Pain Intensity Score(Baseline, Week 7)
- Mean Change From Baseline in PROMIS Anger Score(Baseline, Week 7)
- Percentage of Participants Who Complete the Pain Reprocessing Therapy Intervention(Baseline, Week 7)
- Percentage of Participants Who Report Satisfaction With Pain Reprocessing Therapy(Week 7)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
PRT for Chronic Low Back PainChronic Low Back Pain (CLBP)Nociplastic PainNCT07696741University Health Network, Toronto30
已完成
不适用
Painhunting Therapy for Event Related DepressionLoss-Related DepressionInterpersonal LossComplicated GriefNCT07490691Painhunting LLP84
进行中（未招募）
不适用
Pain Reprocessing Therapy for Chronic Primary PainNociplastic PainChronic Primary PainNCT07287072University of Oslo12
尚未招募
不适用
Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related DepressionDepression - Major Depressive DisorderNCT07738146Painhunting LLP60
尚未招募
不适用
Rewiring Chronic PainFull PRTPartial PRT (Non Somtic)Treatment as UsualNCT07724808Ben-Gurion University of the Negev150