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临床试验/NCT05805397
NCT05805397招募中不适用

Motivation Skills Training to Enhance Functional Outcomes for People With Schizophrenia

Columbia University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Motivation and Pleasure Scale (MAP)

研究概览

简要总结

This study will take place at four outpatient clinics serving adults with serious mental illness. Informed consent will be obtained from N=80 individuals with a Diagnostic and Statistical Manual of Mental Illnesses (DSM)-5 diagnosis of schizophrenia or schizoaffective disorder meeting inclusion/exclusion criteria to participate in a randomized controlled trial comparing Motivation Skills Training (MST) to a Healthy Behaviors Control (HBC) group. Eligible participants will receive a baseline assessment including sociodemographic and psychosocial assessments, measures of motivation, goal attainment, and quality of life, as well as measures of executive skills, community functioning, and psychiatric symptoms severity. Both MST and HBC will be implemented as once weekly group therapies. The treatment phase is approximately 12-14 weeks. MST will focus on motivation knowledge and self-regulation skills while HBC will focus on physical health and health-related skills.

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
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

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

  • 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 three months determined by DSM-5 criteria
  • Neurologic condition causing brain disease
  • Mild to severe cognitive impairment associated with possible dementia measured by a Mini Mental Status Exam score below 20 in individuals ages 60 and older

结局指标

主要结局

Motivation and Pleasure Scale (MAP)

时间窗: 5 months

MAP is a 9-item interviewer rated measure of motivation, pleasure, and engagement in work, school, recreational and social activities. The MAP total score is the sum of all items with a possible range from 0 to 36, with lower scores indicating better outcomes.

Goal Attainment Scaling (GAS)

时间窗: 5 months

GAS measures progress towards personal goal attainment, rated along a continuum of predetermined successful outcomes on a scale from 0 to 10. A single rating is used to quantify goal attainment with higher scores indicating better outcomes.

次要结局

  • Heinrich's Quality of Life Scale (QLS)(5 months)

研究者

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

Alice Saperstein, PhD

Assistant Professor of Medical Psychology

Columbia University

研究点 (2)

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