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Clinical Trials/NCT05805397
NCT05805397RecruitingNot Applicable

Motivation Skills Training to Enhance Functional Outcomes for People With Schizophrenia

Columbia University2 sites in 1 country80 target enrollmentStarted: April 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
80
Locations
2
Primary Endpoint
Goal Attainment Scaling (GAS)

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •DSM-5 Diagnosis of Schizophrenia or Schizoaffective Disorder
  • •Medically and psychiatrically stable outpatient status
  • •English Fluency

Exclusion Criteria

  • •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

Arms & Interventions

Motivation Skills Training (MST)

Experimental

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

Intervention: Motivation Skills Training (Behavioral)

Healthy Behaviors Control Group

Active Comparator

HBC is a weekly group-based intervention that provides psychoeducation and skills training to help individuals improve physical health

Intervention: Healthy Behaviors Control Group (Behavioral)

Outcomes

Primary Outcomes

Goal Attainment Scaling (GAS)

Time Frame: 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.

Motivation and Pleasure Scale (MAP)

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alice Saperstein, PhD

Assistant Professor of Medical Psychology

Columbia University

Study Sites (2)

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