Short-term Efficacy Evaluation of a Psychotherapeutic Intervention Model in Nursing on Nursing Diagnosis "Anxiety": A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 主要终点
- Change in the Level of Anxiety (NOC outcomes "Anxiety Level" and "Anxiety Self-Control" - Portuguese version)
研究概览
简要总结
This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on the nursing diagnosis "Anxiety". A randomised controlled trial will be carried out to do so.
详细描述
This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on nursing diagnosis "Anxiety" (according to International Classification for Nursing Practice (ICNP)/North American Nursing Diagnoses Association (NANDA) standardized nursing language). A randomised controlled trial will be carried out to do so. In a single-blinded nurse-led 6 months controlled trial, conducted at a hospital outpatient setting in Portugal, approximately 60 patients with anxiety will be randomised to the intervention (n=30) or control groups (n=30). The objective is to compare the outcomes associated with "treatment-as-usual" and the benefits of implementing the psychotherapeutic intervention model in nursing previously developed (5 sessions), which will be evaluated using Nursing Outcomes Classification (NOC) outcomes "Anxiety Level" and "Anxiety Self-Control" (Portuguese version).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-64 years old;
- •Nursing Diagnosis "Anxiety" (according to ICNP/NANDA standardized nursing language) - assessment using NOC outcome "Anxiety Level" (Portuguese version);
- •Elementary education (completed).
排除标准
- •Psychiatric diagnosis of dementia or psychotic spectrum disorder;
- •Being in therapy provided by a psychologist (at the moment of the session 0);
- •Cognitive impairment (assessment using Mini-Mental State Examination);
- •Moderate or severe intellectual disability;
- •Confusional state;
- •Psychomotor agitation.
研究组 & 干预措施
Psychotherapeutic Intervention(s) for Anxiety
People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will be treated using Nursing Interventions Classification (NIC) psychotherapeutic intervention(s) for anxiety (plus psychopharmaceuticals).
干预措施: NIC Psychotherapeutic Intervention(s) for Anxiety (Behavioral)
Psychotherapeutic Intervention(s) for Anxiety
People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will be treated using Nursing Interventions Classification (NIC) psychotherapeutic intervention(s) for anxiety (plus psychopharmaceuticals).
干预措施: Psychopharmaceuticals (any drugs prescribed by the psychiatrist) (Drug)
Treatment-as-Usual for Anxiety
People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will receive treatment as usual for anxiety (psychopharmaceuticals).
干预措施: Psychopharmaceuticals (any drugs prescribed by the psychiatrist) (Drug)
结局指标
主要结局
Change in the Level of Anxiety (NOC outcomes "Anxiety Level" and "Anxiety Self-Control" - Portuguese version)
时间窗: At the beginning of the study (Session 0) and one week after session 5 (approximately 6 weeks after the beginning of the study)
次要结局
未报告次要终点
研究者
Francisco Miguel Correia Sampaio
RMN, MSc, PhD Student
Universidade do Porto