Clinical trial NCT05805397: Effectiveness of Motivation Skills Training (MST)
Official title: Motivation Skills Training to Enhance Functional Outcomes for People With Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Mental Illness
Motivation Skills
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-04-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized group assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Motivation and Pleasure Scale (MAP)
timeFrame: 5 months
measure: Goal Attainment Scaling (GAS)
timeFrame: 5 months
Secondary outcomes:
measure: Heinrich's Quality of Life Scale (QLS)
timeFrame: 5 months
Other outcomes:
measure: Barkley Deficits in Executive Functioning Scale - Short Form (BDEFS-SF)
timeFrame: 5 months
measure: Specific Levels of Functioning (SLOF)
timeFrame: 5 months
measure: Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS)
timeFrame: 5 months
Locations:
city: New York
country: United States
facility: The Bridge, Inc.
state: New York
city: New York
country: United States
facility: New York State Office of Mental Health
state: New York
Study officials:
affiliation: Columbia University
name: Alice Saperstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: