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临床试验/NCT05746455
NCT05746455已完成不适用

Motivation Skills Training to Enhance Functional Outcomes for People With Schizophrenia (Open Trial)

Columbia University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年5月30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
8
试验地点
1
主要终点
Change in Motivation and Pleasure Scale (MAP)

研究概览

简要总结

This study will take place at one outpatient clinic serving adults with serious mental illness and will recruit ten individuals (N=10) with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder to participate in an Open Trial of Motivation Skills Training (MST). MST is a weekly group-based skills training intervention that aims to improve knowledge about one's level and sources of motivation, the ability to monitor and regulate (understand and manage) motivation, so that one can better initiate and sustain goal-directed behavior. Participants who consent for research will complete assessments of motivation, goal attainment, quality of life, executive functioning, community functioning, and psychiatric symptoms severity. The intervention phase will be approximately 12 weeks in duration and will entail weekly MST group sessions. At treatment endpoint, participants will be asked to repeat the assessment battery from baseline as well as a satisfaction survey. Change in motivation, goal attainment and quality of life will indicate whether MST is engaging the hypothesized target (motivation) and whether there is impact on functioning.

详细描述

Schizophrenia is a major public health problem associated with core motivational deficits that are amongst the strongest predictors of impaired functional outcomes. Without motivation, people are unable to maintain their pursuit of employment or educational goals, engage in treatment, and regularly participate in healthy life decisions. Current pharmacological and psychosocial treatments for schizophrenia have demonstrated limited effectiveness for improving this core symptom. Motivation Skills Training (MST) is a novel intervention that addresses this clinical need. The premise of MST is that knowledge about one's level and sources of motivation underlies the ability to regulate (i.e., understand and manage) motivation, and that motivation self-regulation can in turn facilitate task initiation and persistence. By facilitating goal-directed behavior, MST aims to enhance daily functioning and goal attainment in people with schizophrenia. MST teaches people about motivation and how to self-regulate motivation, empowering individuals to become active agents in controlling their own motivation and behavior. This study uses a 2-phase model of intervention testing to establish the feasibility, acceptability and pilot effectiveness of MST for adults ages 18-65 with a schizophrenia spectrum diagnosis. An initial open trial of MST in one outpatient clinic will provide stakeholder input on the acceptability and clinical utility of MST content and format, informing refinements to the treatment manual. A subsequent randomized controlled trial will test the effectiveness of MST versus a Healthy Behaviors Control (HBC) group, both conducted in the context of routine recovery-oriented services.

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

  • A primary Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia or schizoaffective disorder
  • Medically and psychiatrically stable outpatient status
  • English Fluency

排除标准

  • Indications of Intellectual Disability as documented in medical history or measured by < 70 premorbid full scale Intelligence Quotient (IQ) estimate
  • Severe substance use within the past 3 months determined by DSM-5 criteria
  • Neurologic condition causing brain disease
  • Mild to severe cognitive impairment associated with possible dementia

结局指标

主要结局

Change in Motivation and Pleasure Scale (MAP)

时间窗: Baseline and up to 14 weeks

MAP is an interviewer rated measure of motivation, pleasure, and engagement in work, school, recreational and social activities. Possible total scores range from 0 to 36, with lower scores indicating better outcomes. The average MAP score ranges from 0-4 with lower scores indicating better outcomes.

Change in Goal Attainment Scaling (GAS)

时间窗: Baseline and up to 14 weeks

GAS measures progress towards personal goal attainment, rated along a continuum of predetermined successful outcomes on a scale from 0 to 10. Higher scores indicate better outcomes.

次要结局

  • Change in Heinrichs Carpenter Quality of Life Scale (QLS)(Baseline and up to 14 weeks)

研究者

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

Alice Saperstein, PhD

Associate Professor of Medical Psychology (in Psychiatry)

Columbia University

研究点 (1)

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