Impact of an Intervention with a Narrative Approach in Overusers in Primary Health Care: a Controlled and Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Change from baseline in affective social support at 1 month, 6 months, and 18 months
研究概览
简要总结
The goal of this clinical trial is to compare an intervention with a narrative therapy-based approach with standard care in overusers in general practice . The main question it aims to answer are:
• An intervention with an approach based on narrative therapy can improve the perception of emotional support, and reduce the probability of suffering from anxiety and/or depression, the number of consultations, and the number of medications in primary care overusers.
Participants will 10 individual sessions carried out over five months. The interval between sessions will be two weeks with a specific duration of fifty minutes per session..
If there is a comparison group: Researchers will compare two groups of overusers to see if reduces the number of visits to the primary care doctor.
详细描述
Background: The best treatment for the excessive use of the consultation is currently being discussed.
Hypothesis: An intervention with an approach based on narrative therapy, compared to standard care, leads to reducing psychosocial distress and reducing the number of consultations with the family doctor.
Objective: To evaluate the effectiveness of an intervention based on co-constructing a new narrative of symptoms of non-organic origin compared to usual clinical care, with respect to affective social support, the probability of suffering from anxiety and/or depression, and the use of the medical consultation.
Methodology: Pragmatic, controlled and randomized, non-masked clinical trial. Study subjects: 264 users (132 in each group, intervention and control) with excessive use of the consultation (95th percentile of the distribution of appointment-type and/or urgent visits to the medicine service). Intervention will be compared with narrative approach + standard care / standard care.
Determinations: Symptoms of anxiety and depression, social support, number of consultations, age, sex, marital status, educational level, income level, employment status.
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
- None
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Users in the 95th percentile in the distribution of consultations face-to-face, patient self-initiated consultations with PHC services within the period of 1 year.
排除标准
- •Drug abuse or dependence, except for nicotine and tetrahydrocannabinol.
- •Comorbidity with DSM-IV-TR (American Psychiatric Association, 2000) severe mental disorders.
- •Comorbidity with ICD-10 (World Health Organization, 2008) severe cognitive disorders or sensory disabilities.
- •Major locomotor mobility limitations or terminal illness
结局指标
主要结局
Change from baseline in affective social support at 1 month, 6 months, and 18 months
时间窗: Before randomization and at the end of treatment at 1 month, six months and 18 months
\- Health-related social support: Affective social support: between 5-14 poor social support / between 15 and 25 good social support. Confidential social support: between 6-17 no confidential social support / between 18 and 30 good social support. Total social support: between 11-32 no social support / between 33-55 social support It is a variable that values people's perception, from a person-centered approach to care: For its measurement we will use the DUKE-UNC functional social support scale. This is a questionnaire self-assessment consisting of 11 items that evaluates perceived social support using a five-point Likert scale. This scale provides three indicators: Affective social support with a range between 25 and 5, being the point of cut of 15; Confidential social support with a range between 30 and 6 points, being cut-off point of 18 and total social support with a range between 55 and 11 points, the cut-off point being 33. If the final score is below 33, the considers absence
次要结局
- Change from baseline in probability of having an anxiety or depressive at 1 month, 6 months, and 18 months(Before randomization and at the end of treatment at 1 month, six months and 18 months)
- Change from baseline in variables related to drug exposure at 1 month, 6 months, and 18 months(Before randomization and at the end of treatment at 1 month, six months and 18 months)
- Number of visits patient self-initiated consultations with PHC services, and totals, per year(Before randomization and at the end of treatment at 1 month, six months and 18 months)
研究者
Valentin Calvo Rojas
Principal Investigator
Catalan Institute of Health