Implementation of a Transdiagnostic Emotion-focused Treatment for Comorbid Emotional Problems and Chronic Pain in Clinical Care. A Sequential Replicated and Randomized Single Case Experimental Design (SCED).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire (PHQ-9) change
研究概览
简要总结
In society today, mental health problems, specifically stress-, anxiety- and depressive disorders, are a primary cause of long-term sick leave, leading to significant societal costs and suffering. One important issue hindering implementation of successful treatments is that there is a marked co-occurrence between these problems and somatic health problems, such as different types of pain. An important key to solving this problem is to develop a more integrated conceptualization of, and treatment model for, these patients' health problems. Specifically, one way to understand the co-occurrence between mental and somatic health problems is offered by the 'transdiagnostic' perspective. The aim of this project is to implement and evaluate the effectiveness of a transdiagnostic emotion-focused treatment protocol in clinical context. The treatment addresses comorbid mental (stress, anxiety- and depressive) and somatic health (pain) problems and targets core emotion regulation processes that are hypothesized to maintain and exacerbate these problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data is collected using a secure digital platform. Outcome assessors will be blinded to baseline length allocations.
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
- •> 11 points on the anxiety or depression subscale, Hospital Anxiety and Depression scale
- •somatic health problems (pain > 3 months) with functional impairment (>3 on question 2 of the Multidimensional Pain Inventory, MPI, OR > 20 points on question 21-24 of the Örebro Musculoskeletal Pain Questionnaire, ÖMPQ)
排除标准
- •severe psychiatric problems requiring immediate other treatment
- •current psychological treatment
- •recently started psychopharmacological treatment for anxiety or depression (<3 months prior to planned treatment)
- •insufficient mastery of the Swedish language
结局指标
主要结局
Patient Health Questionnaire (PHQ-9) change
时间窗: repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks.
change in self rated depression. Scale range 0-27 (higher values worse outcome)
Pain change
时间窗: repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks.
change in pain intensity (scale 0-6) and interference. Scale range 0-6 (higher values worse outcome)
Generalised Anxiety Disorder (GAD-7) change
时间窗: repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks.
change in self rated anxiety. Scale range 0-27 (higher values worse outcome)
Symptom Catastrophizing Scale (SCS) change
时间窗: Baseline, 5 months and 11 months as well as repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks.
Change in catastrophic interpretation of symptoms. Scale range 0-14 (higher values worse outcome)
Pain coping change
时间窗: repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks.
change in pain worry (scale 0-6) and avoidance (scale range 0-8) (higher values worse outcome)
次要结局
- Psychological Inflexibility in Pain Scale (PIPS) change(Baseline, 5 months and 11 months)
- Mini international neuropsychiatric interview (MINI)(Baseline, 5 months)
- EQ5-D change(Baseline, 5 months and 11 months)
- Montgomery Åsberg Depression Rating Scale (MADRS) change(Baseline, 5 months and 11 months)
- Difficulties in Emotion Regulation Scale (DERS-16) change(Baseline, 5 months and 11 months)
- Work limitation questionnaire-16 change(Baseline, 5 months and 11 months)
- Multidimensional Pain Inventory (MPI) change(Baseline, 5 months and 11 months)
- Insomnia Sleep Inventory (ISI) change(Baseline, 5 months and 11 months)