Effects of a Psychosocial Teleassistance Programme for Adults With Spina Bifida
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Quality of life - The World Health Organization WHOQOL-BREF Quality of Life Assessment
研究概览
简要总结
This clinical trial assesses the effect of a telecare psychosocial intervention designed for adults with spina bifida. The intervention consists of 10 weekly 1.5-hour group sessions, followed by two 3-month follow-up sessions. Each group will consist of 6 to 7 individuals. The intervention is aimed at strengthening aspects of self-concept, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.
详细描述
The present study undertakes the development and evaluation of a structured, psychosocial teleassistance intervention designed for adult individuals with spina bifida. The variables of interest and intervention include quality of life, self-esteem, self-concept, anxious-depressive symptomatology, interpersonal needs and coping strategies. The study aims to test whether the psychosocial teleassistance programme improves the aforementioned variables.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be diagnosed with spina bifida by a specialist.
- •Being between 18 and 75 years old.
- •Having their informed consent or the informed consent of their legal guardians.
- •Having Spanish as one of their main languages.
- •Having access to a computer (with a camera, microphone and speakers integrated) and Internet connection to take part in the videoconferences.
排除标准
- •Age that is inconsistent with the established range.
- •The presence of any comorbid diagnosis or sensory deficit that would impede the effective execution of the intervention's activities.
研究组 & 干预措施
Psychosocial teleassistance intervention
Psychosocial intervention, comprising 10 group sessions, followed by two 3-month follow-up sessions, is offered.
干预措施: Psychosocial teleassistance intervention (Behavioral)
Wait list
Waiting list control group.
干预措施: Psychosocial teleassistance intervention (Behavioral)
结局指标
主要结局
Quality of life - The World Health Organization WHOQOL-BREF Quality of Life Assessment
时间窗: 3 months after the intervention
The World Health Organization WHOQOL-BREF Quality of Life Assessment (WHOQOL-BREF) is a tool designed to assess quality of life using twenty-six items. The questionnaire measures four different domains: physical health, psychological health, social relationships, and environment. Domain scores are transformed to a scale ranging from 0 to 100. Higher scores reflect better quality of life.
Anxiety and depression - The Hospital Anxiety and Depression Scale
时间窗: 3 months after the intervention
The Hospital Anxiety and Depression Scale (HADS) is a scale primarily designed to assess anxiety and depressive symptomatology using 14 items. The instrument is composed of two subscales: an anxiety subscale and a depression subscale. Total scores on each subscale range from 0 to 21, where a higher score is indicative of greater symptom severity.
Depression - The Patient Health Questionnaire
时间窗: 3 months after the intervention
The Patient Health Questionnaire (PHQ-9) is a brief, nine-item tool designed to detect and measure the severity of depression. The score can range from 0 to 27. Higher scores reflect more severe depressive symptoms, whereas lower scores indicate minimal or no depressive symptoms.
Self-esteem - The Rosenberg Self-Esteem Scale
时间窗: 3 months after the intervention
The Rosenberg Self-Esteem Scale (RSE) is a 10-item scale designed to assess self-esteem. The final score ranges from 10 to 40. Higher scores reflect greater self-esteem, whereas lower scores indicate reduced self-esteem.
Self-Concept - Self-Concept Questionnaire Form-5
时间窗: 3 months after the intervention
The Self-Concept Questionnaire Form-5 (AF-5) is an instrument used to evaluate self-concept across five dimensions: social, academic-work/professional, emotional, family, and physical. Domain scores are transformed to a scale ranging from 0 to 10. Higher scores indicate a better self-concept across domains, while lower scores reflect worse self-concept in those areas.
次要结局
- Functionality - The Barthel Index(3 months after the intervention)
- Coping strategies - The Brief Cope Stress Questionnaire(3 months after the intervention)
- Interpersonal Needs - The Interpersonal Needs Questionnaire(3 months after the intervention)