NCT05805397

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
4mo left

Started Apr 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Apr 2024Nov 2026

First Submitted

Initial submission to the registry

March 21, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

2.5 years

First QC Date

March 21, 2023

Last Update Submit

November 3, 2025

Conditions

Keywords

Mental IllnessMotivation Skills

Outcome Measures

Primary Outcomes (2)

  • 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.

    5 months

  • 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.

    5 months

Secondary Outcomes (1)

  • Heinrich's Quality of Life Scale (QLS)

    5 months

Other Outcomes (3)

  • Barkley Deficits in Executive Functioning Scale - Short Form (BDEFS-SF)

    5 months

  • Specific Levels of Functioning (SLOF)

    5 months

  • Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS)

    5 months

Study Arms (2)

Motivation Skills Training (MST)

EXPERIMENTAL

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

Behavioral: Motivation Skills Training

Healthy Behaviors Control Group

ACTIVE COMPARATOR

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

Behavioral: Healthy Behaviors Control Group

Interventions

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.

Also known as: MST
Motivation Skills Training (MST)

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.

Also known as: HBC
Healthy Behaviors Control Group

Eligibility Criteria

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

You may qualify if:

  • Age 18-65
  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Bridge, Inc.

New York, New York, 10025, United States

RECRUITING

New York State Office of Mental Health

New York, New York, 10032, United States

NOT YET RECRUITING

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Alice Saperstein, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized group assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medical Psychology

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 10, 2023

Study Start

April 15, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

November 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

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
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.

Locations