Motivation Skills Training for Schizophrenia

NCT ID: NCT05746455

Last Updated: 2024-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Keywords

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Motivation Skills Training

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Motivation Skills Training (MST)

Participants will complete a baseline assessment, receive weekly MST sessions in a group format for a duration of 12 weeks, and will then repeat the assessment battery from baseline as well as a satisfaction survey.

Group Type EXPERIMENTAL

Motivation Skills Training (MST)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age 18-65
2. A primary Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia or schizoaffective disorder
3. Medically and psychiatrically stable outpatient status
4. English Fluency

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Alice Saperstein, PhD

Associate Professor of Medical Psychology (in Psychiatry)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alice Saperstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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The Bridge Inc

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1R34MH129552-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

8394-1

Identifier Type: -

Identifier Source: org_study_id