跳至主要内容
临床试验/NCT03887559
NCT03887559招募中不适用

Adding a Group Based Stabilization and Skill Training Intervention for Patients With Long Lasting Posttraumatic Reactions Receiving Outpatient Treatment in Specialized Mental Health Care - A Randomized Controlled Trial

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
Questionnaire about Process of Recovery' (QPR) Change from baseline

研究概览

简要总结

This study evaluates the addition of a group based stabilization and skill-training intervention to individual out-patient treatment for long lasting post-traumatic reactions. Half of the participants will receive the combined treatment while the other half will receive individual treatment as usual.

详细描述

Many patients in mental health care have previously experienced life-stressors and traumatic events that are related to the problems they seek treatment for. Although the diagnostic labels vary, the clinical picture often demonstrates long lasting complex psychological and somatic post-traumatic symptoms such as avoidance, bodily activation, difficulties in regulating emotions and in relationships with others, impaired quality of life and reduced level of function. Patients often receive long-term individual therapy in general mental health care, occasionally without clinically significant improvement. Still, they continue treatment due to high symptom pressure and low level of functioning. The study targets a novel intervention which tests the effect of adding a group based stabilization and skill training intervention to conventional individual treatment among 160 patients already receiving treatment in a community mental health hospital. Change in variables covering mental health issues, functional impairment, well-being, use of hospital services and drug prescriptions will be examined, as well as markers of inflammation found in sera before and after intervention. The purpose is to develop better and more effective treatment options for a large number of patients who receive mental health care in community mental health hospitals.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Receiving treatment in ordinary out-patient clinics
  • Having been exposed to or witnessing to traumatic event(s) defined as "one or several extremely threatening or horrific events or series of events or situations being of such a character which is likely to overwhelming distress in almost anyone in a similar situation", measured by Stressful Life Events Screening Questionnaire
  • Presenting with posttraumatic reactions such as hyperarousal, avoidance, intrusions, emotional dysregulation or interpersonal difficulties.
  • Symptom duration for a minimum of six months.
  • Understand and speak Norwegian to an extent that is required to participate in a stabilization- and skill-training group.

排除标准

  • Active psychotic symptoms.
  • Substance or drug addiction or abuse.
  • High suicidal risk considered by the individual therapist.
  • Having participated in the course previously.

结局指标

主要结局

Questionnaire about Process of Recovery' (QPR) Change from baseline

时间窗: 12 months after intervention group has completed group treatment

Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)

次要结局

  • The Clinical Outcome in Routine Evaluation (CORE-10) change from baseline(4 weeks, 6 months and 12 months after intervention group has completed group treatment)
  • WHO Five Well-Being Index (WHO-5) change from baseline(4 weeks, 6 months and 12 months after intervention group has completed group treatment)
  • The International Trauma Questionnaire (ITQ) change from baseline(4 weeks, 6 months and 12 months after intervention group has completed group treatment)
  • The Work and Social Adjustment Scale (WSAS) change from baseline(4 weeks, 6 months and 12 months after intervention group has completed group treatment)
  • Posttraumatic Cognition Inventory (PTCI-9) change from baseline(4 weeks, 6 months and 12 months after intervention group has completed group treatment)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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