search
Back to results

Effectiveness of Motivation Skills Training (MST) (MST)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivation Skills Training
Healthy Behaviors Control Group
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 Mental Illness, Motivation Skills

Eligibility Criteria

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

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

Sites / Locations

  • New York State Office of Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivation Skills Training (MST)

Healthy Behaviors Control Group

Arm 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

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

Outcomes

Primary Outcome Measures

Motivation and Pleasure Scale (MAP)
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.
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. A single rating is used to quantify goal attainment with higher scores indicating better outcomes.

Secondary Outcome Measures

Heinrich's 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
March 21, 2023
Last Updated
September 29, 2023
Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT05805397
Brief Title
Effectiveness of Motivation Skills Training (MST)
Acronym
MST
Official Title
Motivation Skills Training to Enhance Functional Outcomes for People With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
November 2025 (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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized group assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivation Skills Training (MST)
Arm Type
Experimental
Arm 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
Arm Title
Healthy Behaviors Control Group
Arm Type
Active Comparator
Arm Description
HBC is a weekly group-based intervention that provides psychoeducation and skills training to help individuals improve physical health
Intervention Type
Behavioral
Intervention Name(s)
Motivation Skills Training
Other Intervention Name(s)
MST
Intervention 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 immediately following treatment completion and 2-months after.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Behaviors Control Group
Other Intervention Name(s)
HBC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motivation and Pleasure Scale (MAP)
Description
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.
Time Frame
5 months
Title
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. A single rating is used to quantify goal attainment with higher scores indicating better outcomes.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Heinrich's 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
5 months
Other Pre-specified Outcome Measures:
Title
Barkley Deficits in Executive Functioning Scale - Short Form (BDEFS-SF)
Description
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.
Time Frame
5 months
Title
Specific Levels of Functioning (SLOF)
Description
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.
Time Frame
5 months
Title
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS)
Description
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.
Time Frame
5 months

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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Saperstein, PhD
Phone
646-774-8464
Email
Alice.Saperstein@nyspi.columbia.edu
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
New York State Office of Mental Health
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Medalia, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Effectiveness of Motivation Skills Training (MST)

We'll reach out to this number within 24 hrs