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临床试验/NCT06851637
NCT06851637已完成不适用

Reducing Symptoms of Depression, Stress and Anxiety and Enhancing Positive Mental Health: a Randomized-controlled Study of the Positive Emotions Training

Ruhr University of Bochum2 个研究点 分布在 1 个国家目标入组 297 人开始时间: 2022年11月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
297
试验地点
2
主要终点
Positive Mental Health Scale (PMH)

研究概览

简要总结

Based on the results of the previously published paper "Positive Emotions Training (PoET) as an online intervention to improve mental health: a feasibility study" (Niemann et al., 2023) the goal of this study was to examine the effects of the "Positive Emotions Training" on mental health in a randomized-controlled study. Furthermore, possible predictors for the efficacy of PoET are to be explored.

Hypotheses:

  1. It was hypothesized that participants receiving PoET would show a significant increase in positive mental health factors at the second assessment point (T2) at end of the second training day.
  2. Furthermore, participants receiving PoET are to be expected to show a significant decrease in depression, anxiety and stress symptoms at T2.
  3. It was hypothesized that the changes in mental health factors remain stable up to the last assessment point (T3) three month after the training.
  4. Lastly, it was hypothesized that there would be no significant changes in the positive or negative mental health factors in the control group at T2 and T3.
  5. The possible predictors of the training's efficacy were not hypothesized, but examined in exploratory investigations.

Methods:

The final sample was n = 207 with n = 90 in the PoET group and n = 117 in the control. The control group did not receive any intervention in the experimental period, but was offered to participate in a later PoET. The allocation was randomized. Participants in the PoET group completed two online training sessions (3 hours each) via Zoom. Group size was about 25-30 people. The sessions included the following positive psychology constructs: happiness, humour, optimism, loving kindness and gratitude on the first day, and hope, self-efficacy, meaningfulness, forgiveness and resilience on the second day. All participants completed a questionnaire at the beginning of the first training session, at the end of the second one as well as three months after the second session. Participants were given an exercise booklet for all exercises (during the training sessions and at home). The one-week break between the two sessions was advertised as a "7-day-challenge" to improve the motivation in participants to exercise at home.

Data was collected pseudonymised via "qualtrics". Data analyses were conducted with RStudio. For the possible effects of PoET on mental health two-factorial repeated measures ANOVAs were conducted. For the exploration of possible predictors for the efficacy of the training, a hierarchical regression was conducted.

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

  • legal age (18), ability to use Zoom and all associated technology

排除标准

  • 未提供

结局指标

主要结局

Positive Mental Health Scale (PMH)

时间窗: before 1st and after 2nd training session, three months after 2nd training session

9 items, 4-point-scale from 0 ("I do not agree ") to 3 ("I agree"), assessing emotional and psychological aspects of wellbeing, higher scores reflect better positive mental health

Depression Anxiety Stress Scale 21 (DASS-21)

时间窗: before 1st and after 2nd training session, three months after 2nd training session

21 items, 4-point-scale from 0 ("did not apply to me at all") to 3 ("applied to me very much or most of the time"), assessing negative emotional states, higher scores reflect more symptoms of depression, anxiety and stress

次要结局

  • Life Orientation Test revised (LOT-r)(before 1st and after 2nd training session, three months after 2nd training session)
  • Satisfaction with Life Scale (SWLS)(before 1st and after 2nd training session, three months after 2nd training session)
  • Brief Resilience Scale (BRS)(before 1st and after 2nd training session, three months after 2nd training session)
  • Perceived Stress Questionnaire (PSQ)(before 1st and after 2nd training session, three months after 2nd training session)
  • Socio-demographic data(before 1st training session)
  • Satisfaction in different areas of life(before 1st and after 2nd training session, three months after 2nd training session)
  • Implementation of at-home exercices(after 2nd training session and three months after 2nd training session)

研究者

发起方
Ruhr University of Bochum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lara Steinmann

Master of Science (M. Sc.) in Clinical Psychology

Ruhr University of Bochum

研究点 (2)

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