search
Back to results

Motivation Skills Training for Schizophrenia (MST)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivation Skills Training (MST)
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Motivation, Skills Training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Bridge Inc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Motivation Skills Training (MST)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Motivation and Pleasure Scale (MAP)
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.
Change in Goal Attainment Scaling (GAS)
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.

Secondary Outcome Measures

Change in Heinrichs Carpenter Quality of Life Scale (QLS)
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.

Full Information

First Posted
February 17, 2023
Last Updated
September 29, 2023
Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT05746455
Brief Title
Motivation Skills Training for Schizophrenia
Acronym
MST
Official Title
Motivation Skills Training to Enhance Functional Outcomes for People With Schizophrenia (Open Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Motivation, Skills Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open Trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivation Skills Training (MST)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivation Skills Training (MST)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Motivation and Pleasure Scale (MAP)
Description
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.
Time Frame
Baseline and up to 14 weeks
Title
Change in Goal Attainment Scaling (GAS)
Description
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.
Time Frame
Baseline and up to 14 weeks
Secondary Outcome Measure Information:
Title
Change in Heinrichs Carpenter Quality of Life Scale (QLS)
Description
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.
Time Frame
Baseline and up to 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Saperstein, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Bridge Inc
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Motivation Skills Training for Schizophrenia

We'll reach out to this number within 24 hrs