A Randomized, Wait List-Controlled, Clinical Trial of IBD Strong Peer for Self-Management of Psychological Distress by Persons Living With Inflammatory Bowel Diseases (IBD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- General quality of life score (Eq5D-3L )
研究概览
简要总结
Psychological distress (PD) as a result of inflammatory bowel disease (IBD) is prevalent and associated with worse disease-related outcomes. IBD-associated psychological distress (IBD-PD) is particularly common at initial diagnosis, during disease flares, before surgery, and during transitions of care. Access to evidence-based, gold-standard psychological interventions and emotional support for IBD-PD has been identified as a major care gap by persons living with IBD. The COVID-19 pandemic has further exacerbated the burden of PD for persons living with chronic diseases like IBD, predisposing at-risk individuals to even greater mental struggles. Studies have shown a minority of patients are asked about IBD-PD in routine clinical care and that even if asked, access to mental health care is extremely limited. iPeer2Peer is an evidence-based, peer-led, virtually administered intervention for IBD-PD in the pediatric population that has demonstrated feasibility, acceptability and early effectiveness. Using qualitative data derived from an extensive stakeholder engagement process, iPeer2Peer has been adapted to meet the needs of adults living with IBD-PD. This program, IBD Strong Peer, will be studied through a randomized, wait list-controlled hybrid implementation-effectiveness trial in Nova Scotia. This study will provide implementation data needed to improve and adapt the intervention and implementation strategy to meet local needs, as well as provide early effectiveness data. This data will inform the design and statistical power needed for future larger, multicenter randomized control trials. IBD Strong Peer has significant potential to improve access to evidence-informed interventions for IBD-PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult IBD patient (18 years or older)
- •In a period of transition (newly diagnosed, transitioning from pediatric to adult care, flaring or changing medications, recently admitted to hospital, or facing the need for surgery)
排除标准
- •Screening positive for severe psychological pathology
- •Do not speak English
- •Diagnosis of a major comorbid psychiatric condition such as bipolar disorder or schizophrenia,
- •No access to the internet
研究组 & 干预措施
IBD Strong Peer2Peer intervention
干预措施: IBD Strong Peer2Peer (Behavioral)
Waitlist -controls
干预措施: Waitlist control (Other)
结局指标
主要结局
General quality of life score (Eq5D-3L )
时间窗: week 8
General quality of life score measured by the European Quality of Life 5 Dimensions 3 Level Version (Eq5D-3L) index
General quality of life score (SF-36)
时间窗: week 8
General quality of life score measured by the SF-36 questionnaire
Fidelity
时间窗: week 8
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Recruitment success
时间窗: week 8
recruitment success \[participation/ total number approached or referred\]
IBD Related quality of life score
时间窗: week 8
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Psychological distress (DSM-V)
时间窗: week 8
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Attrition rate
时间窗: week 8
Rate of participants who drop out of the study
Adherence rate
时间窗: week 8
Rate of participants who adhere to the study protocol
Participant Satisfaction
时间窗: week 8
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index \< 0.9 = suboptimal satisfaction)
Participant Self efficacy score
时间窗: week 8
Self-efficacy, measured by the New General Self Efficacy Scale
Psychological distress (PSS)
时间窗: week 8
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Psychological distress (GAD7)
时间窗: week 8
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Psychological distress (PHQ8)
时间窗: week 8
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
次要结局
未报告次要终点
研究者
Jennifer Jones
Clinical Gastroenterologist, Associate Professor, Department of Medicine, Dalhousie University
Nova Scotia Health Authority
