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临床试验/NCT03019718
NCT03019718已完成不适用

Implementation of the Online Aftercare Intervention 'GSA-Online Plus' (Healthy and Without Stress at the Workplace)

Johannes Gutenberg University Mainz6 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
6
主要终点
Recommendation rate of 'GSA-Online plus'

研究概览

简要总结

The purpose of this study is to implement the internet-based aftercare program 'GSA-Online plus' in several rehabilitation clinics with patients of different indications (psychosomatic, orthopedic and cardiovascular diseases). 'GSA-Online plus' is an internet-based aftercare program for patients with work-related problems or anxieties facing return to work after longterm sickness absence and inpatient rehabilitation. The patients have access to various exploratory and motivational videos on the study website until their inpatient rehabilitation ends. Afterwards, they start a 12-week writing intervention based on a psychotherapeutic concept, the psychodynamic 'Core Conflictual Relationship Theme Method (CCRT)'. Patients write weekly online diary entries which are answered by anonymous online therapists usually within 24 hours. In a previous randomised controlled trial the efficacy of the intervention was determined, whereas the current study focuses on the implementation and realization in a naturalistic setting (effectiveness).

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

性别
All
接受健康志愿者

入选标准

  • Referral (physician) or request (patient) to take part in the internet-based aftercare program
  • Current or prospective employment within 4 weeks after inpatient rehabilitation
  • Private internet access
  • Informed consent
  • Knowledge of the German language

排除标准

  • Severe psychiatric or somatic disease

结局指标

主要结局

Recommendation rate of 'GSA-Online plus'

时间窗: study inclusion (T1)

How often will 'GSA-Online plus' be recommended as an aftercare after inpatient rehabilitation?

Number of patients participating in 'GSA-Online plus'

时间窗: 12 weeks after study inclusion (T14)

At least 66% of patients with a corresponding recommendation should use 'GSA-Online plus' at least once.

次要结局

  • Working ability measured with the short form of the "Work Ability Index" (WAI)(At study inclusion (T1) and 12 weeks later (T14))
  • Somatic symptom burden measured with the Somatic Symptom Scale-8 (SSS-8)(At study inclusion (T1) and 12 weeks later (T14))
  • Depressive symptoms measured with a subscale of the "Patient Health Questionnaire" (PHQ-9)(At study inclusion (T1) and 12 weeks later (T14))
  • Loneliness measured with the "Loneliness Scale" (LS-S)(At study inclusion (T1) and 12 weeks later (T14))
  • Future prospects of employment measured with the "Subjective Prognosis of Work Ability Scale" (SPE)(At study inclusion (T1) and 12 weeks later (T14))
  • Anxiety measured with the "General Anxiety Disorder Scale" (GAD-7)(At study inclusion (T1) and 12 weeks later (T14))
  • Psychological stress measured with the "Perceived Stress Scale" (PSS-4)(At study inclusion (T1) and 12 weeks later (T14))
  • Psychosocial stressors measured with a subscale of the "Patient Health Questionnaire" (PHQ-10)(At study inclusion (T1) and 12 weeks later (T14))
  • General capability measured with the "Sheehan-Disability Scale"(At study inclusion (T1) and 12 weeks later (T14))
  • Personal resources measured with the "Oslo Support Scale" (OSS-3)(At study inclusion (T1) and 12 weeks later (T14))
  • Overall health status measured with the "EQ-5D-3L" questionnaire(At study inclusion (T1) and 12 weeks later (T14))
  • Regular Monitoring of self-rated health status(up to 12 weeks from study inclusion (T2-T13))
  • Personal resources measured with the "Brief Resilient Coping Scale" (BRCS)(At study inclusion (T1) and 12 weeks later (T14))
  • Willingness to pay(12 weeks after study inclusion (T14))
  • Regular Monitoring of self-rated work ability(up to 12 weeks from study inclusion (T2-T13))
  • Evaluation of the therapeutic feedback(up to 12 weeks from study inclusion (T2-T13))
  • Evaluation of GSA-Online+(12 weeks after study inclusion (T14))

研究者

发起方
Johannes Gutenberg University Mainz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Rüdiger Zwerenz

Principle Investigator

Johannes Gutenberg University Mainz

研究点 (6)

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