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临床试验/NCT06631911
NCT06631911终止不适用

Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms in Routine Psychiatric Care: A Pilot Study

Daniel Maroti1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11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
终止
发起方
入组人数
20
试验地点
1
主要终点
Patient Health Questionnaire-15 (PHQ-15)

研究概览

简要总结

Emotional Awareness and Expression Therapy (EAET) has emerged as a promising approach for addressing persistent physical symptoms (PPS). Investigating EAET within the context of routine psychiatric care is crucial for several reasons:

Many patients with PPS experience significant distress and functional impairment, yet traditional medical treatments often fail to provide adequate relief. Integrating EAET into routine care could offer a valuable therapeutic option for this population.

Preliminary studies suggest that EAET can lead to significant reductions in pain and other somatic symptoms. Investigating its effectiveness in routine care settings could enhance treatment outcomes for patients who have not responded to conventional therapies.

There is often a disconnect between mental health and physical health treatment in routine care. Investigating EAET can help bridge this gap, fostering collaboration between mental health professionals and primary care providers to address the complexities of patients' health issues.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • The participant certifies that they have undergone a medical assessment for their physical symptoms (see separate certificate).
  • The participant rates either moderate distress from physical symptoms on the PHQ-15 questionnaire (over 10 points) or significant distress from a single physical symptom (at least 2 points for that symptom).
  • The participant expresses interest in exploring whether emotional factors, such as stress, may contribute to their symptom profile.
  • Any prescribed medications must have been stable for at least one month.

排除标准

  • Participants suffer from ongoing substance abuse (alcohol or drugs) or are assessed to have severe mental health issues (psychotic disorders, moderate to high suicide risk, antisocial personality disorder, etc.).
  • Participants are currently prescribed medications that are clearly addictive and sedative in nature (e.g., benzodiazepines).
  • Participants are involved in other psychological treatments focused on physical symptoms. However, other psychological treatments are permitted as long as the supportive therapy does not occur more than once a month.
  • Participants do not have sufficient proficiency in the Swedish language.
  • Please note that it is the chief physician of each respective research sponsor who, based on collected anamnesis and self-assessment information, makes the final decision regarding whether a participant should be included or excluded from the research project.

研究组 & 干预措施

Emotional Awareness and Expression Therapy

Other

Please see description for intervention

干预措施: Emotional Awareness and Expression Therapy (EAET) (Behavioral)

结局指标

主要结局

Patient Health Questionnaire-15 (PHQ-15)

时间窗: Pre-post treatment (at treatment termination)

Somatic symptom severity during the "last week " are assessed with the Patient Health Questionnaire-15 (PHQ-15). Items are rated 0 ("not bothered at all"), 1 ("bothered a little"), or 2 ("bothered a lot"); total scores range from 0 to 30.

Visual Analoge Scales

时间窗: Pre-post treatment (at treatment termination)

A second primary outcome is the two Visual Analoge Scales suggested by the EURONET-SOMA network (Rief et al., 2017). Somatic symptom intensity is measured from 1 ("No symptom") to 10 ("Symptom as bad as you can imagine") and somatic symptom interference from 1 ("No interference") to 10 ("Maximum interference").

次要结局

  • Sheehan Disability Scale(1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).)
  • Post traumatic symptom Check List-5 (PCL-5),(1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).)
  • Patient Health Questionaire-9 (PHQ-9)(1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).)
  • Patient Health Questionaire-15 (PHQ-15)(Pre-FU (12 weeks after intervention))
  • Generalized Anxiety Disorder 7-item scale (GAD-7)(1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).)
  • Visual Analoge Scales(Pre-FU (12 weeks after intervention))

研究者

发起方
Daniel Maroti
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniel Maroti

PhD, principal investigator

Stockholm University

研究点 (1)

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