- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05805397
Effectiveness of Motivation Skills Training (MST) (MST)
November 3, 2025 updated by: Alice Saperstein, PhD, Columbia University
Motivation Skills Training to Enhance Functional Outcomes for People With Schizophrenia
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.
Study Overview
Status
Recruiting
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 (Estimated)
80
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 Contact
- Name: Alice Saperstein, PhD
- Phone Number: 646-774-8464
- Email: Alice.Saperstein@nyspi.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10025
- Recruiting
- The Bridge, Inc.
-
Contact:
- Kizzy Massey
-
New York, New York, United States, 10032
- Not yet recruiting
- New York State Office of Mental Health
-
Contact:
- Alice Medalia, PhD
-
-
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
- 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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 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 immediately following treatment completion and 2-months after.
Other Names:
|
|
Active Comparator: Healthy Behaviors Control Group
HBC is a weekly group-based intervention that provides psychoeducation and skills training to help individuals improve physical health
|
Participants will complete a baseline assessment, receive weekly HBC sessions in a group format for a duration of 12 weeks, and will repeat the assessment battery from baseline immediately following treatment completion and 2-months after.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 months
|
|
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.
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heinrich's Quality of Life Scale (QLS)
Time Frame: 5 months
|
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.
|
5 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barkley Deficits in Executive Functioning Scale - Short Form (BDEFS-SF)
Time Frame: 5 months
|
BDEFS-SF is a self report measure of executive skills relevant to goal-directed behaviors.
A summary score is the sum of all 20 items, each rated on a 4-point scale, with a range of 20 to 80 where higher scores indicate greater severity of executive dysfunction.
|
5 months
|
|
Specific Levels of Functioning (SLOF)
Time Frame: 5 months
|
SLOF rates functioning with each item scored on a 5-point scale measuring physical functioning, personal care skills, interpersonal relationships, social acceptability, activities of community living, and work skills.
Scores within each domain are the sum of all domain items with higher scores reflecting better functioning.
|
5 months
|
|
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS)
Time Frame: 5 months
|
SCI-PANSS is a semi-structured interview that assesses symptoms of psychotic disorders.
Items are each rated from 1 to 7. The total score is the sum of all items, ranging from 30-210, with higher scores indicating greater severity of symptoms.
|
5 months
|
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)
April 15, 2024
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
November 30, 2026
Study Registration Dates
First Submitted
March 21, 2023
First Submitted That Met QC Criteria
April 5, 2023
First Posted (Actual)
April 10, 2023
Study Record Updates
Last Update Posted (Estimated)
November 5, 2025
Last Update Submitted That Met QC Criteria
November 3, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAU8435
- 1R34MH129552-01A1 (U.S. NIH Grant/Contract)
- 8394-2 (Other Identifier: New York State Psychiatric Institute Institutional Review Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
A list of all data expected to be collected in association with this clinical trial will be submitted to the National Institute of Mental Health (NIMH) Data Archive.
Descriptive and raw data will be submitted on a semi-annual basis.
IPD Sharing Time Frame
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
All data and materials will be made available for research to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with the NIMH Data Archive.
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.
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