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临床试验/NCT04600401
NCT04600401Unknown不适用

Efficacy of Positive Mental Health Program for Adults

Carme Ferré Grau2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年5月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Positive Mental Health Questionnaire (PMHQ) - moment 1

研究概览

简要总结

The aim of this study is to evaluate the efficacy of a positive mental health program for adults, designated Mentis Plus+, in community. Our hypotheses are:

  1. compared with the wait-list control group, the persons who join the experimental group and participate in the Mentis Plus+, will have more positive mental health on the end of the program;
  2. in the Mentis Plus+ participants, positive mental health will be increased at the end of the program and at follow-up (three- six months later) and their psychological vulnerability will reduce.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

the researcher, who will collect the outcome assessments and assume data entry and analysis, will stay blinded to treatment allocations.

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

  • to be a participant aged ≥ 18;
  • participant without a diagnosis of psychiatric pathology;
  • agree to participate in the program by signing informed consent;
  • participant with the "low-level or languising" in at least one factor of the positive mental health questionnaire

排除标准

  • non-Portuguese speakers

结局指标

主要结局

Positive Mental Health Questionnaire (PMHQ) - moment 1

时间窗: PMHQ will be applied in the baseline of the Mentis Plus+ Program, to both groups

The PMHQ consists of 39 items. In the PMHQ, values between 39 (minimum value) and 156 (maximum value) can be obtained, and higher the value obtained, lower the positive Mental Health level is. Therefore, we can categorize different levels of Positive Mental Health: High level or Flourishing (Results between 39-78), Intermediate level (Results between 79-117) and Low level or Languising (Results between 118-156).

Psychological Vulnerability Scale (PVS) - moment 1

时间窗: PVS will be applied in the baseline of the Mentis Plus+ Program, to both groups

The PVS is a six-item scale. Each item is measured in a scale Frequency Likert five points (1-5), where a higher number corresponds to greater frequency (does not describe me at all = 1 to describes me very well = 5). Possible total scores range from 6 to 30, with higher scores indicating greater psychological vulnerability. greater psychological vulnerability.

Psychological Vulnerability Scale (PVS) - moment 3

时间窗: PVS will be reapplied for follow-up of the evaluation, after completion of the study, on average 3 months, in both groups

The PVS is a six-item scale. Each item is measured in a scale Frequency Likert five points (1-5), where a higher number corresponds to greater frequency (does not describe me at all = 1 to describes me very well = 5). Possible total scores range from 6 to 30, with higher scores indicating greater psychological vulnerability. greater psychological vulnerability.

Positive Mental Health Questionnaire (PMHQ) - moment 2

时间窗: PMHQ will be applied up to 18 weeks of the Mentis Plus + Program,to both groups

The PMHQ consists of 39 items. In the PMHQ, values between 39 (minimum value) and 156 (maximum value) can be obtained, and higher the value obtained, lower the positive Mental Health level is. Therefore, we can categorize different levels of Positive Mental Health: High level or Flourishing (Results between 39-78), Intermediate level (Results between 79-117) and Low level or Languising (Results between 118-156).

Positive Mental Health Questionnaire (PMHQ) - moment 3

时间窗: The PMHQ will be reapplied for follow-up of the evaluation, after completion of the study, on average 3 months, in both groups

The PMHQ consists of 39 items. In the PMHQ, values between 39 (minimum value) and 156 (maximum value) can be obtained, and higher the value obtained, lower the positive Mental Health level is. Therefore, we can categorize different levels of Positive Mental Health: High level or Flourishing (Results between 39-78), Intermediate level (Results between 79-117) and Low level or Languising (Results between 118-156).

Psychological Vulnerability Scale (PVS) - moment 2

时间窗: PVS will be applied up to 18 weeks of the Mentis Plus + Program,to both groups

The PVS is a six-item scale. Each item is measured in a scale Frequency Likert five points (1-5), where a higher number corresponds to greater frequency (does not describe me at all = 1 to describes me very well = 5). Possible total scores range from 6 to 30, with higher scores indicating greater psychological vulnerability. greater psychological vulnerability.

次要结局

  • Sociodemografic and clinical data - moment 1(Sociodemografic and clinical data will be applied in the baseline of the Mentis Plus+ Program, to both groups)
  • Sociodemografic and clinical data - moment 3(Sociodemografic and clinical data will be reapplied for follow-up of the evaluation, after completion of the study, on average 3 months, in both groups)
  • Sociodemografic and clinical data - moment 2(Sociodemografic and clinical data will be applied up to 18 weeks of the Mentis Plus + Program,to both groups)

研究者

发起方
Carme Ferré Grau
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Carme Ferré Grau

Clinical Professor

University Rovira i Virgili

研究点 (2)

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