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临床试验/NCT05942495
NCT05942495已完成不适用

A Pilot Study on the Effectiveness of Schema Focused Group Therapy for Persistent Anxiety and Depressive Symptoms: a Single Case Experimental Design

GGZ Noord-Holland-Noord2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年7月18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
发起方
入组人数
15
试验地点
2
主要终点
Anxiety and depressive symptoms, as repeatedly measured by (an idiosyncratic set of) a self-report questionnaire; the Depression Anxiety Stress Scales-21 (DASS-21).

研究概览

简要总结

Rationale: Although there are effective treatments available for anxiety and depression, there is a large group of clients that does not benefit sufficiently from first-choice treatment. For this group of clients, no suitable alternative exists yet. One of the main hypothesis about maintaining factors is that there are underlying personality features that impede recovery. Schema focused therapy (SFT) is a transdiagnostic therapy focusing on underlying personality features. It has been proven to be an effective therapy for people with personality disorders and there are initial indications that SFT is also an effective treatment for anxiety and depressive symptoms. A short-term schema focused group therapy (SFGT) has been developed within GGZ-NHN, which is expected to benefit clients with persistent anxiety and depressive symptoms, but has not yet been studied.

Objective of the study: In the present study the effectiveness of short-term SFGT (protocol of De Jager, Burger & Groot) on (1) persistent anxiety and depressive symptoms, and (2) early maladaptive schemas (EMS), experiential avoidance and the mode of the healthy adult will be investigated.

详细描述

Study design: A Single Case Experimental Design (SCED), using repeated measures over four different phases.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persistent anxiety or depression symptoms (at least moderate score at the subscale depression (≥7 or anxiety ≥6 on the DASS-21).
  • History of at least one previous evidence-based therapy focused on anxiety, depression or PTSD according to the Dutch national guidelines.
  • Able to comprehend Dutch at a level sufficient to complete self-report.

排除标准

  • Clients with severe problems that need to be addressed first, including substance abuse, psychosis, anxiety disorder, PTSD or depression that not have been treated.
  • Start of (or change in) medication which is not yet stabilized at the start of this study.
  • Psychosocial problems such as homelessness, no income or high debts which would make the clients unable to participate in a group.

研究组 & 干预措施

SFGT

Experimental

Whitin subject design with one arm; SFGT groep intervention

干预措施: short-term schema focused group therapy (Behavioral)

结局指标

主要结局

Anxiety and depressive symptoms, as repeatedly measured by (an idiosyncratic set of) a self-report questionnaire; the Depression Anxiety Stress Scales-21 (DASS-21).

时间窗: From baseline to follow-up, total of 37-40 weeks. We will administrate 10 items, idiosyncratically chosen. Measured once every 4 days.

The DASS-21 consists of three subscales (Depression, Anxiety, and Stress). Each item can be rated on a scale from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time"). All subscales content 7 items which makes the score range 0-21 for each subscale. Higher scores indicate the experience of more severe symptoms

次要结局

  • Early maladaptive schemas as measured with the Young Schema Questionnaire Short Form (YSQ-S3).(From baseline to follow-up, total of 37-40 weeks. Complete YSQ will be filled in 5 times during study. Two early maladpative schema's, 10 items, idiosyncratically chosen will be measured once every 16 days)
  • Personality pathology as measured by the Level of Personality Functioning-screener brief form (LPFS-BF);(25 weeks; before start baseline and after finishing therapy)
  • Experiential avoidance as measured with the Brief Experiential Avoidance Questionnaire (BEAQ).(From baseline to follow-up, total of 37-40 weeks. BEAQ will be filled in once every 16 days)
  • Schema modi as measured with the Schema Modi Inventory (SMI)(From baseline to follow-up, total of 37-40 weeks. Complete SMI will be filled in 5 times during study. Mode of the healthy parent, 10 items, will be measured once every 16 days)
  • General psychopathology as measured by the (totalscore of the) Outcome Questionnaire (OQ-45)(37-40 weeks; OQ-45 will be filled in 5 times during study)

研究者

发起方
GGZ Noord-Holland-Noord
申办方类型
Other
责任方
Sponsor

研究点 (2)

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