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临床试验/NCT05100875
NCT05100875已完成不适用

Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis: A Pilot Feasibility and Acceptability Study

Douglas Mental Health University Institute2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Participant completion rate

研究概览

简要总结

This study will investigate if the SSERT (Social Skills and Emotion Regulation Training) intervention is feasible and acceptable in individual with psychotic disorder and a history of trauma.

详细描述

Many individuals with psychotic disorders experience poor functional outcomes such as lower quality of life, lower levels of education, and lower life expectancy. Comorbid mental disorders, such as posttraumatic stress disorder and related posttraumatic stress symptoms tend to aggravate psychotic symptoms and, as a result, worsen functional outcomes. Further, emotion regulation and interpersonal functioning are generally impaired in individuals with psychotic disorders and histories of childhood trauma, and preliminary evidence suggests that these impairments may mediate the relationship between childhood trauma and psychotic symptom severity. Despite the high levels of trauma observed in psychotic populations, the last decade has seen only a modest increase in the number of trials examining the efficacy of trauma interventions in this population. Further, given the initial distress, destabilization, and increased vulnerability that may occur when first engaging in trauma-focused intervention, it has been argued that in those with psychotic disorders, stabilizing/grounding interventions may be a necessary fist step prior to engagement in trauma therapy. This study will thus assess whether the Social Skills and Emotion Regulation Training (SSERT) for Trauma in Psychosis is feasible and acceptable to offer as a preparatory intervention, and will examine its preliminary effect on emotion regulation, interpersonal functioning, and other functional outcomes. SSERT proposes a single-arm baseline with post-intervention design. We will recruit 20 participants with a psychotic disorder, a history of trauma, and an impairment in interpersonal functioning and/or emotion regulation. The intervention will consist of nine weekly hour-long individual sessions and one final 90-minute session. The feasibility of SSERT will be assessed by examining the profile or safety of the study (including whether there are any adverse events reported), the participant flow (missed sessions, attrition rates, retention/completion rates), and through both standardized and qualitative items assessing therapist feedback. The acceptability of SSERT will be assessed subjectively, specifically though participant responses on therapy satisfaction, therapeutic alliance, and motivation for therapy questionnaires. Qualitative analyses will identify common themes and assess participant comments. We expect that SSERT will be both feasible and acceptable to administer to this population. Any expectations regarding the intervention's effect in improving emotion regulation, interpersonal functioning, and other functional outcomes is exploratory. Overall, SSERT may help people with psychotic disorders to better understand how the experience and effect of trauma impacts their relationships and emotion management. The intervention may also help to improve functional outcomes and relationship quality by teaching emotion regulation and grounding strategies, and through learning to become more engaged and flexible in relationships.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • (1) diagnosis of a schizophrenia spectrum or other psychotic disorder including affective psychosis;
  • (2) trauma history meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) PTSD criterion A;
  • (3) at least a mild impairment in either emotional regulation or interpersonal functioning, identified using predetermined cut-offs of ≤ 2 on the Emotion Regulation Skills Questionnaire or ≥ 1 on the Inventory or Interpersonal Problems-32 ;
  • (4) at least 18 years of age;
  • (5) clinically stable/taking a stable dose of antipsychotic medication;
  • (6) French or English-speaking; and
  • (7) with no major physical illness.

排除标准

  • (1) history of a medical or neurological condition that can affect cognition, which will be verified via participant self-report;
  • (2) current severe substance use disorder; and
  • (3) an IQ score below 70, estimated using the Wechsler Abbreviated Scale of Intelligence - Two subtest version (vocabulary, matrix reasoning)

结局指标

主要结局

Participant completion rate

时间窗: 10 weeks of the intervention

Feasibility, percentage of participants to complete at least 50% of sessions

The Satisfaction with Therapy Questionnaire

时间窗: Completion time 5 minutes

Acceptability/satisfaction, self-report questionnaire

Client Motivation for Therapy Scale

时间窗: Completion time 5 minutes

Acceptability, self-report questionnaire

Adverse events

时间窗: 10 weeks of the intervention

Feasibility, number of recorded adverse events directly associated with the trial

Working Alliance Inventory-Short Revised

时间窗: Completion time 5 minutes

Acceptability, self-report questionnaire

SSERT Feasibility Questionnaire-Therapist

时间窗: Completion time 10 minutes

Feasibility, self-report questionnaire completed by the therapist

Client Satisfaction Questionnaire

时间窗: Completion time 5 minutes

Acceptability/satisfaction, self-report questionnaire

次要结局

  • Emotion Regulation Skills Questionnaire(Completion time 5 minutes)
  • Inventory of Interpersonal Problems- 32(Completion time 5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Lepage

Clinical professor

McGill University

研究点 (2)

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