Effectiveness of Motivation Skills Training (MST)

NCT ID: NCT05805397

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2026-11-30

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Motivation Skills Training

Intervention Type: BEHAVIORAL

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.

Healthy Behaviors Control Group

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

Group Type: ACTIVE_COMPARATOR

Healthy Behaviors Control Group

Intervention Type: BEHAVIORAL

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.

Interventions

Motivation Skills Training

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

Healthy Behaviors Control Group

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MST; HBC

Eligibility Criteria

Inclusion Criteria

1. Age 18-65

2. DSM-5 Diagnosis of Schizophrenia or Schizoaffective Disorder

3. Medically and psychiatrically stable outpatient status

4. English Fluency

Exclusion Criteria

1. Indications of Intellectual Disability as documented in medical history or measured by < 70 premorbid full scale Intelligence Quotient (IQ) estimate

2. Severe substance use within the past three months determined by DSM-5 criteria

3. Neurologic condition causing brain disease

4. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Alice Saperstein, PhD

Assistant Professor of Medical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alice Saperstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

The Bridge, Inc.

New York, New York, United States

Site Status: RECRUITING

New York State Office of Mental Health

New York, New York, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Alice Saperstein, PhD

Role: CONTACT

Alice.Saperstein@nyspi.columbia.edu

646-774-8464

Facility Contacts

Kizzy Massey

Role: primary

Alice Medalia, PhD

Role: primary

Other Identifiers

1R34MH129552-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

8394-2

Identifier Type: OTHER

Identifier Source: secondary_id

AAAU8435

Identifier Type: -

Identifier Source: org_study_id