Impact of an Intervention with a Narrative Approach in Overusers: a Clinical Trial

Официальное название

Impact of an Intervention with a Narrative Approach in Overusers in Primary Health Care: a Controlled and Randomized Trial

Обзор

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.

Подробное описание

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.

Statistical analysis: In order to determine the discriminant capacity of the variables associated with the intervention, we will build a multiple regression model in which we will include those that were statistically significant in the bivariate analysis and those that are relevant according to the bibliography.

Expected results: The results will provide evidence on the effectiveness of said intervention.

Application and Relevance: This type of intervention would most likely reduce the pressure on medical-health professionals.

Вмешательства

• Другое Intervention with a narrative approach.
  Health social workers will carry out a intervention with a narrative approach, through its training profile based on transversal skills, which will consist of 10 sessions carried out over five months. The interval between sessions will be of two weeks with a specific duration of fifty minutes per session. This type of intervention, with the objective of reorienting and redefining the demand or the initial problems that motivated the consultation, gives space to the patient\'s subjective comp

Первичные конечные точки

• Change from baseline in affective social support at 1 month, 6 months, and 18 months [Срок оценки: Before randomization and at the end of treatment at 1 month, six months and 18 months]

Вторичные конечные точки (3)

• Change from baseline in probability of having an anxiety or depressive at 1 month, 6 months, and 18 months [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Before randomization and at the end of treatment at 1 month, six months and 18 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Centre d'Atenció Primària Montnegre, Institut Català de la Salut, Barcelona, Catalonia, Sp — Barcelona

Идентификаторы

NCT: NCT06258512 · CatalanIH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗