REMOTION: a Randomized Controlled Pilot Trial to Investigate the Feasibility and Potential Effectiveness of a Blended, Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- General symptom severity
研究概览
简要总结
Emotion regulation has been identified as an important transdiagnostic factor in the treatment of mental health disorders. This study aims to examine, for the first time, REMOTION, a novel blended therapy intervention aimed at reducing symptom severity and improving emotion regulation of patients in an outpatient psychotherapy setting. REMOTION is an internet based intervention that is administered as an add-on to psychotherapy. This study aims to investigate feasibility and also potential effectiveness of REMOTION in an outpatient setting. Participants will be randomly assigned to the study conditions. Outcomes are assessed at baseline, after six weeks and after twelve weeks.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •In psychotherapeutic treatment at the outpatient clinic of the Department of Clinical Psychology at the University of Bern
- •Mental disorder present
- •Internet access available
- •Written informed consent
排除标准
- •Current participation in another intervention, outside of the treatment at the outpatient clinic, that is geared specifically at emotion regulation
- •Current or history of psychotic disorders or bipolar disorder
- •Acute suicidality
- •Insufficient mastery of German language
研究组 & 干预措施
TAU
Participants in TAU receive psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern.
干预措施: TAU (Behavioral)
REMOTION + TAU
Participants in the REMOTION group receive REMOTION in addition to psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern.
干预措施: TAU (Behavioral)
结局指标
主要结局
General symptom severity
时间窗: 12 weeks
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
次要结局
- Difficulties in emotion regulation(baseline, 6 weeks,12 weeks)
- Depressive Symptoms(baseline, 6 weeks, 12 weeks)
- Health related quality of life(baseline, 6 weeks, 12 weeks)
- Feasibility parameter: adherence(6 weeks, 12 weeks (REMOTION group only))
- Feasibility parameter: program usability(6 weeks, 12 weeks (REMOTION group only))
- Feasibility parameter: attitude toward psychological online interventions(baseline, 6 weeks, 12 weeks)
- Feasibility parameter: satisfaction with the intervention(6 weeks, 12 weeks (REMOTION group only))
- Anxiety symptoms(baseline, 6 weeks, 12 weeks)
- Feasibility parameter: number of participants taking part in the study(at randomization)
- Well-Being(baseline, 6 weeks, 12 weeks)
- Feasibility parameter: user experience(6 weeks, 12 weeks (REMOTION group only))
- Emotion competencies questionnaire(baseline, 6 weeks, 12 weeks)