Clinical trial NCT05746455: Motivation Skills Training for Schizophrenia
Official title: Motivation Skills Training to Enhance Functional Outcomes for People With Schizophrenia (Open Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Motivation
Skills Training
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-02-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Trial
Primary purpose: TREATMENT

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.

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. A primary Diagnostic and Statistical Manual of Mental Disorders (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 3 months determined by DSM-5 criteria
3. Neurologic condition causing brain disease
4. Mild to severe cognitive impairment associated with possible dementia

Primary outcomes:
measure: Change in Motivation and Pleasure Scale (MAP)
timeFrame: Baseline and up to 14 weeks
measure: Change in Goal Attainment Scaling (GAS)
timeFrame: Baseline and up to 14 weeks
Secondary outcomes:
measure: Change in Heinrichs Carpenter Quality of Life Scale (QLS)
timeFrame: Baseline and up to 14 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: The Bridge Inc
state: New York
Study officials:
affiliation: Columbia University
name: Alice Saperstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: