Guided Internet-delivered Treatment for Moderate Depression, Social Anxiety Disorder and Panic Disorder - An Open Naturalistic Multicentre Cost-effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- Panic disorder symptoms
研究概览
简要总结
The goal of this observational multicentre study is to address the effectiveness and cost-effectiveness of providing a therapist guided internet based cognitive behavioural therapy (ICBT) for common mental disorders in a routine healthcare setting.
Main research questions is 1) What is the effectiveness of guided internet based treatment for moderate depression, panic disorder and social anxiety disorder across clinics in routine care? 2) What is the cost-effectiveness of guided internet based treatment for moderate depression, panic disorder and social anxiety disorder across clinics? 3) Who benefits from guided internet-delivered treatment? 4) What are the predictors of drop-out from guided internet based treatment? 5) To what extent does user experiences of guided internet based treatment influence adherence and effectiveness? Participants will receive up to nine guided ICBT sessions (modules) and answer questionnaires covering symptoms severity, health related quality of life, work and social ability, user satisfaction and medication. All questionnaires are part of the standard patient follow up routines in the four treatment locations participating in the study. Analytical approach is to compare locations/clinics and subgroups of patients.
详细描述
The therapist guided internet based cognitive therapy (ICBT) cover moderate depression, social anxiety disorder (SAC) and panic disorder (PD).
The eMeistring-program is standard treatment in all four hospitals/locations participating in the study. Patients are recruited through the ordinary clinical patient pathways. After a pre-treatment assessment, an initial face-to-face visit takes place (T1). Patients are given the opportunity to participate in the study based on informed concent. Next, participants in the depression program will receive eight guided internet based cognitive behavioural therapy sessions or modules. Similarly SAC and PD patients will receive nine modules. Therapist guidance are provided at least once a week via a secure email system. When sessions are finished (T2), a new face-to-face visit with the therapist is offered.
Therapists are licensed health personnel e.g. psychologists, registered nurses and clinical social workers, working in the clinics.
Administrative data about covering organizational implementation of the eMeistring treatment program, personnel involved and level of treatment activity is collected separately.
Inclusion criteria's for eMeistring therapy: having moderate depression, panic disorder and social anxiety disorder as a primary disorder, and having computer and internet access.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Having moderate depression, panic disorder and social anxiety disorder as a primary disorder. Access to computer and internet.
排除标准
- •Having severe depression, suicidal impulses and thoughts, bipolar disorders, psychosis, substance abuse, unstable medication last month, severe reading or writing disabilities.
结局指标
主要结局
Panic disorder symptoms
时间窗: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
For panic disorder group: Panic disorder disorder symptoms assessed by PDSS-SR, Panic Disorder Severity Scale. Minimum raw score: 0, maximum raw score: 28. Composite scores range from 0-4. The composite score is the average of the seven items. Higher score indicates higher severity of panic disorder.
Depression severity
时间窗: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
For moderate depression group: Depression severity assessed by PHQ-9, Patient Health Questionnaire score. Minimum score is 0, maximum score is 27. Higher score indicates more severe depression
Social phobia
时间窗: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)
For social anxiety group: Social Phobia assessed by SPIN, Social Phobia Inventory score. Minimum score is 0, maximum score is 68. Higher score indicates more severe phobia.
次要结局
- Depression severity(Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4))
- System Usability(Up to 14 weeks after treatment start (T2))
- Cost of health care services(Period between pre treatment (T1) and up to 14 weeks after treatment start (T2), and to six months after post treatment (T3) and until two years (T4))
- Work participation(Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4))
- Medication(Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4))
- Sickness absenteeism(Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4))
- Health Related Quality of Life(Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4))
- Work and social adjustment(Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4))
- Anxiety severity(Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4))