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临床试验/NCT06432114
NCT06432114已完成不适用

Coping Through Sensory Modulation. A Sensory Awareness Program (SAP) for Reducing Anxiety and Mobilizing Coping Strategies for People With Severe Mental Health Problems. A Randomized Controlled Trial.

Lund University1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
207
试验地点
1
主要终点
Becks anxiety inventory (BAI)

研究概览

简要总结

Few alternatives to addictive medical treatment exists for persons with severe mental health problems (SMHP) and anxiety, often connected to high risk of suicide. Access to effective interventions that depart in individuals' needs to cope with anxiety in everyday life is crucial to provide and desperately warranted by service users. Service users are often unaware of sensory needs, connected to anxiety outburst. The Sensory Awareness Program (SAP) is a group-based self-management intervention of 10 weeks developed to meet complex needs of regulating anxiety and related self-destructive behaviors. SAP stems from theories on sensory modulation and is an approach to manage physiological arousal associated with anxiety through self-regulated sensory-based coping strategies. International research show that sensory modulation is effective both as a method to reduce anxiety and thus restraint in acute mental health services (MHS), and also to empower users. However, much research to date focus on using sensory strategies within wards. International research and pre-studies of testing the SAP in outpatient MHS indicate that it is a promising self-management intervention to support everyday life. Earlier studies further show that users' unawareness of sensory needs triggers anxiety, and that anxiety itself is the main contributing factor for disrupting everyday life. Also, staff acknowledge sensory modulation but lack knowledge on whether programs such as SAP is effective and possible to implement.

The overall aim is to investigate the effectiveness of SAP as compared to treatment as usual (TAU) among 200 outpatients. The investigators hypothesize that SAP will be more effective than TAU in terms of reduced anxiety (primary outcome) at three months follow-up. Secondary clinical and personal recovery outcomes post intervention and at three and six months follow up will also be targeted and assumed to be in favour of the SAP group. The implementation process of the SAP will also be explored.

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 (Investigator, Outcomes Assessor)

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

  • Be assigned to a MHS
  • Age over 18
  • Having SMHP (including a diagnosis of mood disorder, anxiety disorder, eg PTSD, panic disorder etc, and/or psychotic disorder)
  • Experience anxiety

排除标准

  • Acutely mentally unwell
  • Cognitively impaired
  • Non-Swedish speaking

研究组 & 干预措施

Sensory Awareness Program

Experimental

干预措施: Sensory Awareness Program (SAP) (Behavioral)

Sensory Awareness Program

Experimental

干预措施: Treatment as usual (TAU) (Other)

Treatment as usual

Other

干预措施: Treatment as usual (TAU) (Other)

结局指标

主要结局

Becks anxiety inventory (BAI)

时间窗: Before intervention, post intervention (at 3 months), 6 and 9 months

The Beck Anxiety Inventory (BAI) is a self-report questionnaire measuring the severity of anxiety symptoms with 21 questions, each describing a symptom of anxiety. The participant rates each item on a scale from 0 to 3, indicating how much he/she experiences each symptom. The scores range from 0 to 63, with higher scores indicating more severe levels of anxiety.

次要结局

  • Hopkins Symptom Checklist-25 (HSCL-25)(Before intervention, post intervention (at 3 months), 6 and 9 months)
  • Difficulties in Emotion Regulation scale (DERS)(Before intervention, post intervention (at 3 months), 6 and 9 months)
  • Coping Orientation of Problem Experience Inventory (COPE)(Before intervention, post intervention (at 3 months), 6 and 9 months)
  • Manchester Short Assessment of Quality of Life Scale (MANSA)(Before intervention, post intervention (at 3 months), 6 and 9 months)
  • Pearlin Mastery Scale(Before intervention, post intervention (at 3 months), 6 and 9 months)
  • Process of Recovery Questionnaire (QPR-7)(Before intervention, post intervention (at 3 months), 6 and 9 months)
  • Profiles of Occupationa Engagement (POES)(Before intervention, post intervention (at 3 months), 6 and 9 months)
  • The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)(Before intervention, post intervention (at 3 months), 6 and 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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