eBehandling - Health and Work Utility, Use and User Experience of a New Digital Transdiagnostic Work-Focused Intervention for Patients in Specialist Mental Health Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 18
- 主要终点
- Degree of Sickleave
研究概览
简要总结
Mental health problems and disorders affect one in every five amongst the working- age adults in the countries of the Organization for Economic Cooperation and Development. This constitutes a major public health challenge that also has large implications for work participation and productivity.
Major depression and anxiety are the most prevalent of the mental disorders and are therefore named common mental disorders (CMD). CMD have become a major cause of work absenteeism, with 30% of all sick leave in Norway being due to CMDs in 2024.
Early interventions addressing psychological aspects and vocational challenges related to work have shown a positive effect on return to work. Therefore, finding ways to increase availability and reduce barriers to evidence-based treatments seems a viable route to reducing mental health's impact on sick leave and absenteeism.
Research show that improvement in symptoms from ordinary psychotherapy has little impact on sick-leave. The same results have been found for internet-based cognitive therapy (ICBT). One of the challenges in specialised mental health care is that the work focus has been an additive or extended part of the treatment, not integrated in the treatment itself.
Several studies have been conducted on psychological treatments that specifically target return to work for people with CMDs. Systematic reviews have shown that work-focused therapy has a small, but significant effect over treatment as usual on return to work and finds that 20% more workers in the intervention groups had returned to work, compared to control groups.
The availability of traditional therapy is scarce and there is an need for new effective ways of delivery. internet-based cognitive therapy has been shown to be as effective as traditional therapy in many systematic reviews and meta analysis and seems a good approach to reach the goal of increasing availability.
To account for the heterogene group of people on sick leave the investigators have created a transdiagnostic, work-focused internet-based cognitive behaviloural therapy program.
This study aims is to is to investigate the utility and use of this treatment program for patients with common mental health disorders on sick leave or work assessment allowance. This includes the user experience of participation and experienced utility of the treatment program.
详细描述
Study aims The main aim of the current study is to investigate the utility and use of a digital transdiagnostic work-focused CBT treatment program for patients with common mental health disorders on sick leave or work assessment allowance. This includes the user experience of participation and experienced utility of the treatment program. Secondary aims are related to mediators and moderators of treatment efficacy and the participants' experience with the program.
Research questions
- To what extent does the treatment program impact Return to Work, self-reported symptoms, and everyday functioning?
- To what extent do clinical, work-related and demographic factors affect treatment adherence and treatment response?
- To what extent do adherence and changes in work-related self-efficacy predict outcomes?
- What type and frequency of negative effects does participants report?
- How do participants describe their experience of use and utility of the program, as well as its challenges and benefits?
Hypotheses of main effects H1a. The investigators expect a large main effect of treatment on total percentage sick leave from pre- to post treatment, with gains maintained at follow up.
H1b. The investigators expect a large main effect of treatment on the number of participants with full return to work from pre- to post treatment, with gains maintained at follow up.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being an outpatient in specialised mental health care service,
- •above 18 years old,
- •full or graded sick leave, or on work assessment allowance
- •primary diagnosis of F30 - F40 (ICD-10),
- •currently employed.
排除标准
- •ongoing psychotic disorder and/or mania,
- •ongoing substance abuse, incl. sedative medications,
- •ongoing episode of major depression,
- •organic brain disease,
- •severe reading and writing difficulties.
研究组 & 干预措施
Digital transdiagnostic work-focused CBT treatment program
digital transdiagnostic work-focused CBT treatment program for patients with common mental health disorders on sick leave or work assessment allowance
干预措施: Transdiagnostic, work-focused Cognitive Behavioural Therapy (Behavioral)
结局指标
主要结局
Degree of Sickleave
时间窗: baseline, 6 weeks, 12 weeks, 6 months and 12 months
Self-reported degree of sick leave (percentage)
Return to Work Self-efficacy 11
时间窗: baseline, 6 weeks, 12 weeks, 6 months and 12 months
11-item questionnaire measuring an individual's confidence in their ability to work and perform work tasks. Items are scored on a scale from 1 ("Totally disagree") to 6 ("Totally agree"). Items 2 and 6 are reversed.
次要结局
- Generalized Anxiety Disorder-7(baseline, 6 weeks, 12 weeks, 6 months and 12 months)
- Patient Health Questionnaire-9(baseline, 6 weeks, 12 weeks, 6 months and 12 months)
- CORE-10(at 2, 4, 8 and 10 weeks)
- CORE-OM(baseline, 6 weeks, 12 weeks, 6 months and 12 months)
- The Work and Social Adjustment Scale(baseline, 6 weeks, 12 weeks, 6 months and 12 months)
- The Negative Effects Questionnaire(at 12 weeks)