- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05746455
Motivation Skills Training for Schizophrenia (MST)
November 21, 2024 updated by: Alice Saperstein, PhD, Columbia University
Motivation Skills Training to Enhance Functional Outcomes for People With Schizophrenia (Open Trial)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10025
- The Bridge Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18-65
- 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
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 3 months determined by DSM-5 criteria
- Neurologic condition causing brain disease
- Mild to severe cognitive impairment associated with possible dementia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Goal Attainment Scaling (GAS)
Time Frame: 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.
|
Baseline and up to 14 weeks
|
|
Change in Motivation and Pleasure Scale (MAP)
Time Frame: 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.
|
Baseline and up to 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Heinrichs Carpenter Quality of Life Scale (QLS)
Time Frame: Baseline and up to 14 weeks
|
QLS is a semi-structured interview which evaluates psychosocial functional outcome.
QLS is scored by summing the 7 items reflecting four domains: interpersonal functioning, intrapsychic foundations, instrumental role function, and common objects/activities.
Total scores ranges from 0 to 42 where higher scores indicate better functioning.
|
Baseline and up to 14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alice Saperstein, PhD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2023
Primary Completion (Actual)
October 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
February 17, 2023
First Submitted That Met QC Criteria
February 17, 2023
First Posted (Actual)
February 27, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
November 21, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8394-1
- 1R34MH129552-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Raw data will be made available to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with public repositories such as the National Institute of Mental Health (NIMH) Data Archive.
Data will include demographic information, baseline and post raw data derived from primary and secondary outcome measures.
IPD Sharing Time Frame
A list of all data expected will be submitted by July 10, 2023.
Subsequently raw data will be submitted on a semi-annual basis.
Unpublished de-identified data will be submitted prior to study completion and will be shared within one year after project completion or when the data are published, whichever is earlier.
IPD Sharing Access Criteria
Data in NIH repositories may be accessed through the NIH Data Access Committee which reviews data access and submission requests.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Fundació Institut de Recerca de l'Hospital de la...Recruiting
-
First Affiliated Hospital of Fujian Medical UniversityNot yet recruiting
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Newron Pharmaceuticals SPARecruitingTreatment-resistant SchizophreniaUnited States, India
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarCompletedTreatment Resistant SchizophreniaIndia
-
Kaohsiung Medical University Chung-Ho Memorial...Not yet recruitingSchizophrenia Disorder
-
Shanghai Zhongze Therapeutics Co., Ltd.Yale UniversityNot yet recruiting
-
Ole Köhler-ForsbergAarhus University HospitalRecruiting
Clinical Trials on Motivation Skills Training (MST)
-
Boston Children's HospitalNot yet recruiting
-
Columbia UniversityNational Institute of Mental Health (NIMH)RecruitingSchizophrenia | Schizoaffective DisorderUnited States
-
Boston University Charles River CampusSan Francisco State UniversityCompleted
-
Hospices Civils de LyonRecruiting
-
Mersin UniversityCompleted
-
Charles Drew University of Medicine and ScienceNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
Charles Drew University of Medicine and ScienceWithdrawnCancer | Breast Cancer | Lung Cancer | Colon Cancer | Caregiver BurnoutUnited States
-
Elif BakırCompletedType 1 DiabetesTurkey
-
Syracuse UniversityNational Institute of Mental Health (NIMH)CompletedHIV Infections | Child Abuse, SexualUnited States
-
Centre for Addiction and Mental HealthOntario Ministry of Health and Long Term CareCompletedSchizophreniaCanada