Cultivating Well-being Beyond Symptomatology in Subclinical Paranoia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Well-being at 12 weeks, 3 months and 12 months
研究概览
简要总结
The 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 subclinical paranoia. Feliz-Mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions by the use of a mobile application 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 and the daily use of a mobile application of the program) 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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants between 18 and 35 years old
- •At least two standard deviations above mean on the scales of distress, suspicion and /or interpersonal sensitivity in the SCL-90 questionnaire.
排除标准
- •Participants with borderline personality disorder
- •Participants with substance use disorders and /or
- •Participants with severe cognitive impairment.
研究组 & 干预措施
TAU + waiting list
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.
TAU + Feliz-Mente Intervention
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: Feliz-Mente (third generation psychotherapy) (Behavioral)
结局指标
主要结局
Change from Well-being at 12 weeks, 3 months and 12 months
时间窗: Change baseline, 12 weeks, 3 months and 12 months
Psychological Well-Being Scales (Ryff, 1995)
次要结局
- Change from self-esteem at 12 weeks, 3 months and 12 months(Change baseline, 12 weeks, 3 months and 12 months)
- Change from Well-beingDistress at 12 weeks, 3 months and 12 months(Change baseline, 12 weeks, 3 months and 12 months)
- Change from Attachment at 12 weeks, 3 months and 12 months(Change baseline, 12 weeks, 3 months and 12 months)
- Change from Paranoid ideation at 12 weeks, 3 months and 12 months(Change baseline, 12 weeks, 3 months and 12 months)
- additional Outcome Measures Experience of trauma events(baseline)
研究者
Carmen Valiente Ots
Principal Investigator
Universidad Complutense de Madrid