Physiological Reactivity and Psychosocial Functioning in Pediatric Patients With Gastrointestinal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 6
- 主要终点
- Retention Rate
研究概览
简要总结
This is a prospective, assessment-based study to examine the relationship between psychophysiological functioning and psychological symptoms in youth newly diagnosed with inflammatory bowel disease (IBD) compared to healthy controls.
详细描述
Similar to other chronic stressors, diagnosis with a chronic illness places youth at risk of adverse psychosocial outcomes. Inflammatory bowel diseases (IBD), Crohn's disease, ulcerative colitis, and indeterminate colitis are chronic, immune-mediated diseases of the gastrointestinal tract characterized by unpredictable remissions of disease activity followed by relapses of symptoms. Although some research has found higher levels of disease activity to relate to greater depressive symptoms, the overall relationship between disease activity and emotional functioning has been mixed, suggesting that additional individual differences need to be considered in addition to illness-related factors when predicting emotional outcomes. Increased risk for developing anxiety disorders and depression has been documented in youth with IBD. Individual differences in physiological reactivity may affect patients' risk for developing psychosocial difficulties within the context of chronic stress. Additional risk factors for developing psychosocial challenges need to be identified to identify moderators of outcomes above and beyond disease activity.
Individual differences in physiological reactivity may affect patients' risk for developing psychosocial difficulties within the context of chronic stress. Physiological reactivity, which broadly refers to bodily reactions in response to a stressor, varies with regards to intensity and threshold for activation between individuals.
In youth affected by non-medical chronic stress (e.g., family conflict, trauma history), measures of autonomic dysfunction have been used to explain why some individuals have worse psychological and physical outcomes compared to others exposed to similar levels of chronic stress. Results support autonomic dysfunction as a vulnerability factor for adjustment problems within the context of chronic environmental stress.
The current study aims to test whether differences in psychophysiological reactivity serve as risk factors in the relationship between clinical disease activity in youth newly diagnosed with IBD and psychosocial adjustment problems. The relationship between psychophysiological reactivity and psychosocial adjustment problems in youth with IBD will be compared to healthy controls. Youth participants with IBD will be enrolled in a coping skills treatment to test the effectiveness of a cognitive-behavioral intervention including biofeedback to reduce anxiety and depression and disease symptoms. The research team will conduct a pilot intervention targeting autonomic dysfunction through biofeedback-enhanced coping skills treatment delivered virtually over 6-sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with biopsy-confirmed IBD
- •Ages 13 through 18 years inclusive
- •English fluency for parent and child participants.
- •Accompanied by at least 1 parent/guardian who is willing to participate
- •Positive depression or anxiety symptom screen using the patient health questionnaire (PHQ-9) or Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety measures
排除标准
- •Previous diagnosis of intellectual disability
- •Autism spectrum disorder.
- •Parent is unwilling to participate.
研究组 & 干预措施
Wait-list control
Participants randomized to the wait-list control group will complete the same measures of lifetime stress, autonomic reactivity, depression, anxiety. The identical treatment will be offered to control participants after the 6-week time point.
Biofeedback Enhanced Treatment
Participants in this group will participate in biofeedback enhanced cognitive behaviorally based coping skills treatment. Treatment will consist of a 6-visit group intervention conducted online, via Emory zoom. Groups will include 5-8 patients each. Sessions will include brief, daily homework to facilitate mastery that is developmentally tailored to youth (e.g., practice skills with support from phone or tablet apps). Groups will meet approximately every week for 6 weeks. Advanced Ph.D. students in clinical psychology and Principal Investigator will deliver the treatment protocol. They will complete questionnaires before and after each session to measure autonomic reactivity in response to stress induction and coping strategies.
干预措施: Biofeedback Enhanced Treatment (Behavioral)
结局指标
主要结局
Retention Rate
时间窗: 6 weeks (End of treatment), and 2 months post treatment
Retention rates will be summarized using the number of individuals who gave consent to participate in the trial, who completed 6 weeks of the intervention they were randomized to, as well as the count of participants completing the Post-Treatment assessment 2 months after finishing 6 weeks of Biofeedback Enhanced Treatment.
Client Satisfaction Questionnaire (CSQ-8) Scores Following Biofeedback Enhanced Treatment
时间窗: 6 weeks (End of treatment)
Acceptability of the Biofeedback Enhanced Treatment was assessed using adolescent- and parent-reported program satisfaction ratings on the Client Satisfaction Questionnaire (CSQ-8). Adolescents and parents completed this 8-item survey on a 4-point scale, with total scores ranging from 8 to 32; higher scores indicated greater satisfaction. Each group completed the questionnaire 6 weeks after finishing the Biofeedback Enhanced Treatment. No survey was provided to participants during the waitlist phase, as no treatment was administered during the waiting period.
次要结局
- Changes in the Screen for Child Anxiety Related Disorders (SCARED) Scores at 6 Weeks (End of Treatment)(baseline, 6 weeks (End of treatment))
- Change in the Children's Depression Inventory 2 (CDI-2) at Six Weeks Compared to Baseline(6 weeks (End of treatment))
- Change in the Children's Depression Inventory 2 (CDI-2) at 2 Months Post-treatment Compared to Baseline(2 months post-Biofeedback Enhanced Treatment)
- Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 6 Weeks(baseline, 6 weeks (End of treatment))
- Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 2 Months After Completing Treatment Intervention(baseline, 2 months post-treatment)
- Changes in Screen for Child Anxiety Related Disorders (SCARED) Scores in Both Groups at 2 Months After Completing Treatment(baseline, 2 months post treatment)
- Changes in the Children's Somatic Symptoms Inventory (CSSI) 7-item (GI Subscale) After Completion of Biofeedback Enhanced Treatment(baseline, 6 weeks (End of treatment))
- Changes in the Children's Somatic Symptoms Inventory- (CSSI) 7-item (GI Subscale) at 2 Months After Completion of Treatment Intervention(baseline, 2 months post-treatment)
- Change in Autonomic Reactivity at 6 Weeks (End of Treatment)(baseline, 6 weeks (End of treatment))
研究者
Bonney Reed
Associate Professor
Emory University