Effectiveness of Motivation Skills Training (MST)

Schizophrenia Clinical Trial

— MST  

Official title:

Motivation Skills Training to Enhance Functional Outcomes for People With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05805397
• Other study ID #: 8394-2
• Secondary ID: 1R34MH129552-01A
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Alice Saperstein, PhD
• Phone: 646-774-8464
• Email: Alice.Saperstein[@]nyspi.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	New York State Office of Mental Health	New York	New York
United States	The Bridge, Inc.	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Barkley Deficits in Executive Functioning Scale - Short Form (BDEFS-SF)	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.	5 months
Other	Specific Levels of Functioning (SLOF)	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.	5 months
Other	Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS)	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.	5 months
Primary	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
Primary	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	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.	5 months