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临床试验/NCT02375061
NCT02375061已完成不适用

A Positive Psychology Intervention for Fibromyalgia Patients to Promote Physical and Psychological Wellbeing Using Information and Communication Technologies

Universitat Jaume I2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Beck Depression Inventory II

研究概览

简要总结

This study is aimed to test the efficacy of a Positive Psychology Intervention (Best Possible Self, BPS) over optimism, future expectancies and positive affect at mid-term, in comparison to a control group, in fibromyalgia patients. The principal hypothesis is that the BPS intervention will enhance significantly the levels of optimism, positive future expectancies and positive affect in comparison to the Control group at short and mid-term.

详细描述

Previous studies have demonstrated the effects of positive psychological factors in pain adjustment. Specially, optimism has been linked to lower pain sensitivity, better physical functioning, less psychological distress and pain catastrophizing. Until recently, the beneficial effects of optimism on pain have been studied mostly in correlational studies or in experimental interventions in laboratory settings. To address the gap between research and clinical practice, the aim of this study is to test the efficacy of the Best Possible Self intervention (BPS) using Information and Communication Technologies (ICTs) with fibromyalgia patients.

BPS is a guided imagery exercise that requires participants to envision themselves in the future, achieving desired goals in different areas of their lives. This exercise has shown efficacy improving optimism, future expectancies and positive affect compared to a control condition, in general population (Meevissen, Peters & Alberts, 2011; Sheldon &Lyubomirsky, 2012; Peters, Flink, Boersma & Linton, 2010). Taking into account the prior literature, the aim of the present study is to carry out a randomized controlled study in order to replicate the findings about the effects of BPS on optimism, mood and affect in a chronic pain population. The exercise will be applied through a Positive Technology system and the effects will be analyzed during four months. The design employed in this study is similar to the used in other studies (Meevissen et al, 2011; Renner, Schwarz, Peters & Huibers, 2014; Sheldon & Lyubomirsky, 2006).

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 (Participant)

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

  • Patients have to fulfill the American College of Rheumatology criteria for primary FMS.
  • Sign a consent form stating their willingness to participate

排除标准

  • Presence of another severe physical illness
  • Presence of severe psychological disorders
  • Be currently involved in another psychological treatment

结局指标

主要结局

Beck Depression Inventory II

时间窗: 4 months

This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. The instrument has good internal consistency (Cronbach's alpha of 0.76 to 0.95) and test-retest reliability of around 0.8. The Spanish version of this instrument has also shown a high internal consistency (Cronbach's alpha of 0.87) for both the general and the clinical population (Cronbach's alpha of 0.89). Summed to obtain the total score, which can be a maximum of 63 points.

次要结局

  • Pain Catastrophizing(4 months)
  • Positive and Negative Affect Scale(4 months)
  • General Self-Efficacy scale(4 months)
  • Life Orientation Test(4 months)
  • Quality of Life(4 months)
  • Overall Anxiety Severity and Impairment Scale(4 months)
  • Subjective probability task(4 months)

研究者

发起方
Universitat Jaume I
申办方类型
Other
责任方
Sponsor

研究点 (2)

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