NCT05746455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 18, 2024

Completed
Last Updated

December 18, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

February 17, 2023

Results QC Date

November 21, 2024

Last Update Submit

November 21, 2024

Conditions

Keywords

MotivationSkills Training

Outcome Measures

Primary Outcomes (2)

  • 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. The average MAP score ranges from 0-4 with lower scores indicating better outcomes.

    Baseline and up to 14 weeks

  • 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.

    Baseline and up to 14 weeks

Secondary Outcomes (1)

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

    Baseline and up to 14 weeks

Study Arms (1)

Motivation Skills Training (MST)

EXPERIMENTAL

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.

Behavioral: Motivation Skills Training (MST)

Interventions

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.

Motivation Skills Training (MST)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Bridge Inc

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Dr. Alice Saperstein
Organization
Columbia University

Study Officials

  • Alice Saperstein, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medical Psychology (in Psychiatry)

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 27, 2023

Study Start

May 30, 2023

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

December 18, 2024

Results First Posted

December 18, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

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.

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.
Access Criteria
Data in NIH repositories may be accessed through the NIH Data Access Committee which reviews data access and submission requests.

Locations