Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Change in SF-36 physical health (SF-36 PPH scales)
研究概览
简要总结
The aim of this multi-center, two-armed, randomized controlled trial is to assess the effect of a novel internet-based therapist-assisted treatment program "One step at a time" designed for the treatment of patients with moderate to severe functional somatic disorder (FSD).
The trial will enroll 166 patients with FSD who will be randomized (1:1) to either the experimental condition (14 weeks' treatment with "One step at a time") or the active control condition ("GetStarted"), which is a non-guided internet-based treatment program for patients with FSD. The trial will include patients aged 18-60 years with an established single/oligo-organ or multi-organ FSD diagnosis, with a duration of minimum 6 months. The primary outcome measures will be based on self-reported physical health (SF-36 PPH) and treatment satisfaction (CGI-I). The trial will be considered effective if a higher proportion of patients in the experimental condition report a clinically significant outcome compared with patients in the active control condition at the 3-month follow-up after treatment.
详细描述
OBJECTIVE: To assess the clinical efficacy of the therapist-guided internet-delivered treatment program "One step at a time" for functional somatic disorders (FSDs) compared with an active control "Get Started".
DESIGN: The trial will employ a two-armed randomized, controlled design with an active control condition.
PARTICIPANTS: We will include adult patients (18-60 years) with a medical diagnosis of functional somatic disorder. For a description of eligibility criteria, see the section "Eligibility".
PROJECT GROUP: Thomas Tandrup Lamm (Psychologist, MSc.); Lisbeth Frostholm (Professor, Psychologist, MSc., Ph.D.); Heidi Frølund Pedersen (Associate Professor, Psychologist, MSc., Ph.D.); and Brjánn Ljótsson (Associate Professor, Psychologist MSc., Ph.D.).
The trial will be conducted by the research group at the Dept. of Functional Disorders (www.functionaldisorders.dk), based at Aarhus University Hospital, Denmark. The clinic was established in 1999 and offers assessment and specialized treatment to patients with severe FSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must fulfil the criteria for moderate-severe FSD operationalized as being diagnosed with either single/oligo-organ BDS, with 2 organ systems that are each affected by 3 or more symptoms, or multi-organ BDS, with 3 or 4 organ systems that are each affected by 3 or more symptoms.
- •Patients must have symptom duration > 6 months.
- •If older than 25, patients must have been active in the labor market or educational system for at least 12 months during the last 2 years.
- •Patient must have access to a computer or tablet with internet connection.
- •Patient must be able to understand, read, and write Danish fluently.
排除标准
- •Patients are excluded from participation if they present with severe comorbid somatic or psychiatric disease that is insufficiently treated at the time of assessment and is deemed to constitute a potential barrier for engaging in the treatment.
- •Patients are excluded if they lack motivation to engage in internet-delivered treatment.
- •Patients are excluded if they have poor self-reported IT skills.
- •Patients are excluded if they lack informed consent.
- •Patients are excluded if they have ongoing treatments with opioids and benzodiazepines.
- •Patient's use of psychoactive medications should be stable.
结局指标
主要结局
Change in SF-36 physical health (SF-36 PPH scales)
时间窗: Pre-assessment (-2 weeks), baseline (0 weeks), during treatment (weeks 3, 6, and 9), after treatment (14 weeks), at 3-month follow up (26 weeks), and at 12-month follow up (62 weeks)
The SF-36 is a self-reported physical, mental, and social health. Analysis of primary outcome will be based on the PPH subscales. The change that is used to test the main hypothesis is the change from baseline (0 weeks) to 3-month follow-up (26 weeks). The full SF-36 is measured at the following time-points: Pre-assessment (-2 weeks), baseline (0 weeks), after treatment (14 weeks), at 3-month follow up (26 weeks), and at 12-month follow up (62 weeks). During During treatment (week 3, 6, 9), only the SF-36 PPH subscales (Bodily pain, physical functioning, vitality) will be measured.
Clinical Global Improvement Scale (CGI)
时间窗: 3-month follow up (26 weeks)
Single item 5-point self-reported evaluation of overall health improvement. The time point that is used to test the main hypothesis at 3-month follow-up (26 weeks). The CGI is measured on the following time points: After treatment (14 weeks), at 3-month follow up (26 weeks), at 12-month follow up (62 weeks)
次要结局
- Experiences of satisfaction Questionnaire (ESQ)(After treatment (14 weeks))
- Motivation and alliance with therapist (WAI-SR)(Mid-treatment (6 weeks))
- Experiences in close relations (ECR)(Baseline (0 weeks))
- The BDS Checklist-25(Pre-assessment (-2 weeks), Baseline (0 weeks), after treatment (14 weeks) at 3 month follow up (26 weeks) and at 12 month follow up (62 weeks).)
- Brief Illness perception questionnaire (b-IPQ)(Pre-assessment (-2 weeks), Baseline (0 weeks), during treatment (weeks 3, 6, and 9), After treatment (14 weeks), at 3 month follow up (26 weeks) and at 12 month follow up (62 weeks))
- The Behavioural Responses to Illness Questionnaire (BRIQ)(Pre-assessment (-2 weeks), baseline (0 weeks), during treatment (week 3, 6, and 9), after treatment (14 weeks), at 3-month follow up (26 weeks), and at 12-month follow up (62 weeks))
- The Numeric Rating Scale (NRS)(Pre-assessment (-2 weeks), Baseline (0 weeks), During treatment (weeks 3, 6, and 9), After treatment (14 weeks), and at 3 month follow up (26 weeks) at 12 month follow up (62 weeks))
- Emotional distress, anxiety, depression subscales of the 92-item Danish version of the Symptom Checklist (SCL-92)(Pre-assessment (-2 weeks), Baseline (0 weeks), after treatment (14 weeks), at 3-month follow up (26 weeks), and at 12 month follow up (62 weeks).)
- The credibility/expectancy questionnaire (CEQ)(Before treatment (0 weeks) and after treatment (14 weeks))
- Toronto Alexithymia Scale (TAS-20) subscales(Baseline (0 weeks), after treatment (14 weeks))
- Whiteley-6 revised(Pre-assessment (-2 weeks), baseline (0 weeks), after treatment (14 weeks), at 3-month follow up (26 weeks), and at 12-month follow up (62 weeks))
- Costs associated with Psychiatric Illness (TiC-P)(Before treatment (0 weeks), at 3 month follow up (26 weeks) and at 12 month follow up (62 weeks))
- The inventory for the assessment of negative effects of psychotherapy (INEP)(After treatment (14 weeks))
- The Sources of Meaning and Meaning in Life Questionnaire (SoMe short version)(Baseline (0 weeks), After treatment (14 weeks))
- The Internet Evaluation and Utility Questionnaire (iEUQ)(After treatment (14 weeks))
- Interoceptive awareness and Sensitivity Questionnaire (ISAQ)(Baseline (0 weeks), After treatment (14 weeks))
- Emotional Approach Coping scale (EACS)(Baseline (0 weeks), After treatment (14 weeks))
- Amsterdam Resting State Questionnaire (ARSQ)(Baseline (0 weeks), after treatment (14 weeks), at 3-month follow up (26 weeks))
- Somatization sub-scale of the 92-item version of the Symptom Checklist (SCL-92_SOM)(Pre-assessment (-2 weeks), baseline (0 weeks), after treatment (14 weeks) and at 3-month follow up (26 weeks))
- Emotional Distress subscale of the 92-item version of the Symptom Checklist (SCL-92_DIST)(During treatment (weeks 3, 6, 9))
- Socio-Demography(Pre-assessment (-2 weeks), Baseline (0 weeks))
- European Quality of Life 5-dimensions (EQ-5D-5L)(Baseline (0 weeks), after treatment (14 weeks) at 3-month follow up (26 weeks) and at 12-month follow up (62 weeks).)