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临床试验/NCT04768959
NCT04768959已完成不适用

Cultivating Well-being Beyond Symptomatology in Severe Psychiatric Conditions: A Randomized Controlled Trial

Universidad Complutense de Madrid1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
Well-being

研究概览

简要总结

The multicomponet psychological intervention is called Feliz-Mente, with third generation therapy components that aims to improve wellbeing and self-enhancement. Without intervening directly on the symptoms, it is expected to increase positive experiences, the use of personal strengths and positive relationships, and aims to build a more meaningful self-narrative in persons with severe psychiatric conditions. Feliz-Mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions to improve treatment adherence and daily practice. The design for the present study is a randomized controlled trial, which compares the post-intervention measures of the experimental group (group receiving the intervention) with the post-intervention measures of the control group (treatment as usual + waiting list).

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •were aged 18-65 years
  • •had a minimum of motivation and commitment to participate in group therapy

排除标准

  • •limited cognitive resources or serious formal thinking disorder and/or
  • •a concurrent diagnosis of substance dependence or a severe personality disorder that could interfere with benefiting from a psychotherapy group.

研究组 & 干预措施

No Intervention: TAU + waiting list

No Intervention

This control group is a waiting list group. Participants received treatment as usual (TAU). Once the RCT is finished, participants have the chance to participate in the intervention group.

Experimental: TAU + Feliz-Mente Intervention

Experimental

Feliz-Mente (third generation psychotherapy):The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party.

干预措施: FelizMente (Behavioral)

结局指标

主要结局

Well-being

时间窗: Change from Well-being at 12 weeks and 6 months

Psychological Well-Being Scales (Ryff, 1995)

次要结局

  • Attachment(Change from Attachment at 12 weeks and 6 months)
  • Experiential Avoidance(Change from Experiential Avoidance at 12 weeks and 6 months)
  • Self-esteem(Change from self-esteem at 12 weeks and 6 months)
  • Psychological Symptoms(Change from Psychological Symptoms at 12 weeks and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carmen Valiente Ots

Carmen Valiente Ots

Universidad Complutense de Madrid

研究点 (1)

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