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临床试验/NCT05114733
NCT05114733已完成不适用

Individualized Vocational and Educational Support and Training for Clinical High Risk for Psychosis (InVEST)

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年2月22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
26
试验地点
1
主要终点
Feasibility of intervention- recruitment rate

研究概览

简要总结

The purpose of this study is to test the efficacy of InVEST (Individualized Vocational and Educational Support and Training) for CHR-P (clinical high risk for psychosis) to address specific role functioning difficulties associated with the CHR-P phase. Our specific goals are:

  1. Part 1: Preliminary open trial of InVEST (n = 8) to collect preliminary feasibility and acceptability data by providing the intervention, administering assessments, and collecting focus group and self-report feedback from open trial participants. The open trial phase will help to refine recruitment approaches and to modify the treatment manual as needed.
  2. Part 2: Preliminary randomized controlled trial of InVEST vs. Delayed InVEST (DI) to explore preliminary evidence of efficacy of InVEST vs. DI (n = 30). The investigators hope to gain understanding of the feasibility of InVEST and the study's assessment procedures, and to gain a preliminary understanding of the intervention's efficacy for functioning difficulties experienced by young people at CHR-P.

详细描述

InVEST is a novel intervention that aims to target three clusters of mechanisms believed to be key in contributing to increasing functional impairment in CHR-P: 1) executive functioning (a cognitive mechanism), 2) increased stress sensitivity (an emotional mechanism), and 3) task initiation difficulties (a behavioral mechanism). Conceptually, these mechanisms are consistent with a CBT conceptualization of role functioning impairment, and the strategies to target each mechanism will be adapted based on existing evidence-based interventions combined with clinical expertise in CHR-P treatment. Finally, our proposed project is based on robust scientific evidence supporting the need for early intervention, targeting functional impairment and related risk factors in individuals at CHR-P.

This study will be organized in two parts:

Part 1: Manual development and a preliminary open-trial (n = 8) to guide the development and refinement of InVEST through coach experiences and study participant feedback. Participants will complete the intervention and then a post-intervention focus group, providing data on the feasibility of InVEST and to direct the development of the InVEST intervention manual.

Part 2: A small, randomized trial comparing InVEST treatment (2 groups, n = 15 each). Participants will be randomized using a delayed treatment design, with half of participants randomized into InVEST and half randomized into a 4-month Delayed InVEST (DI; 4 month wait to start). Primary outcome measures will include CHR-P symptoms; global role functioning; executive functioning; stress sensitivity; task initiation; hopelessness; and suicidality.

Overview of Intervention: InVEST for CHR-P

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
Single (Outcomes Assessor)

盲法说明

part 1 is open label design. Next part is RCT waiting list control design. assessors will be unaware of whether the participant was in the waiting list condition or the active condition.

入排标准

年龄范围
12 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • can speak English,
  • meet broad CHR-P criteria based on the Structured Interview for Psychosis Risk Syndromes (SIPS),
  • shows at least mild role functioning impairment on the Global Functioning-Role scale (GF:R),
  • parent is willing to provide permission (and client is willing to assent) for invest coaches to communicate with treatment providers.

排除标准

  • Previously met diagnostic criteria for full psychosis on the Structured Interview for Psychosis Risk Syndromes.
  • Does not meet inclusion criteria listed above.

研究组 & 干预措施

InVEST

Experimental

4 month treatment condition

干预措施: InVEST (Behavioral)

delayed invest

No Intervention

participants in delayed invest wait four months and are reassessed before taking part in the intervention

结局指标

主要结局

Feasibility of intervention- recruitment rate

时间窗: baseline

recruitment rates

Feasibility of intervention- drop out

时间窗: 4 months

drop outs

Feasibility of intervention -Client Satisfaction

时间窗: 4 months

Attkisson Client Satisfaction Questionnaire is a seven item scale measuring an individual's personal experience with a service (range 7-28 with higher scores indicating greater level of satisfaction)

次要结局

  • Role functioning(change from baseline to 4 months and baseline to 8 months)

研究者

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

Michelle Friedman-Yakobian

Assistant Professor

Beth Israel Deaconess Medical Center

研究点 (1)

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