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临床试验/NCT02671929
NCT02671929已完成2 期

Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study as an After Care After Inpatient Psychosomatic Treatment

Johannes Gutenberg University Mainz2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
83
试验地点
2
主要终点
Satisfaction of the intervention group with the internet-based self-help program measured with an reworded version of the "patient satisfaction questionnaire" (ZUF-8)

研究概览

简要总结

The purpose of this study is to determine the feasibility and effectiveness of an internet-based self help program concerning satisfaction with the treatment and their life, depression and anxiety. Both study groups get access to the internet-based self-help program. The intervention group receives additional feedback to their progress in the program from an online therapist. The investigators hypothesize that (1) at least 75% of the patients in the intervention group are "satisfied" or "very satisfied" with the self-help program, (2) 50% of the patients in the intervention group work with all eight units and (3) patients of the intervention group have a higher emotional competence than the patients of the control group at the end of the self-help program.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • day care/ inpatient treatment in the Department of Psychosomatic Medicine and Psychotherapy at the University Medical Center of the Johannes Gutenberg-University Mainz
  • minimum age of 18 years
  • private internet access
  • e-mail address

排除标准

  • acute suicidality
  • psychosis
  • current alcohol or drug addiction
  • life time diagnosis of a schizophrenic, schizoaffective, bipolar or organic psychic disorder

结局指标

主要结局

Satisfaction of the intervention group with the internet-based self-help program measured with an reworded version of the "patient satisfaction questionnaire" (ZUF-8)

时间窗: 10 weeks after study inclusion (T1)

次要结局

  • Self-esteem measured with the German version of the "RSE" (Rosenberg Self-Esteem Scale)(10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2))
  • Emotional competence measured with the "SEK-27" (questionnaire for self-assessment of emotional competence)(10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2))
  • Quality of life measured with the German version of the "EUROHIS-QOL 8" (European Health Interview Survey Quality of Life 8)(10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2))
  • Anxiety measured with the German version of the "GAD-7" (General Anxiety Disorder Screener)(10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2))
  • Somatoform afflictions measured with the German version of the "SSS-8" (Somatic Symptom Scale)(10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2))
  • Therapeutic alliance measured with the German version of the "WAI-SR" (Working Alliance Inventory - Short Revised)(10 weeks after study inclusion (T1))
  • Depression measured with the German version of the "PHQ-9" (Patient Health Questionnaire)(10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2))
  • Subjective prognosis of work ability measured with the "SPE" (Subjective Prognosis of Work Ability)(10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2))
  • Acceptance of the internet-based self-help program measured with an especially for the self-help program devised questionnaire(End of every unit (weekly) and 10 weeks after study inclusion (T1))
  • Usage of the internet-based self-help program measured with an especially for the self-help program devised questionnaire(10 weeks after study inclusion (T1))
  • Depersonalisation measured with the German short version of the "CDS-2" (Cambridge Depersonalisation Scale)(10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2))
  • Utilization of alternative after care measures (psychotherapy and drugs) with a self-devised questionnaire(10 weeks after study inclusion (T1))

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 (2)

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