Effectiveness of Motivation Skills Training (MST)

Sponsor
Columbia University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05805397
Collaborator
National Institute of Mental Health (NIMH) (NIH)
80
1
2
22
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivation Skills Training
  • Behavioral: Healthy Behaviors Control Group
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized group assignmentRandomized group assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Motivation Skills Training to Enhance Functional Outcomes for People With Schizophrenia
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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.
Other Names:
  • MST
  • Active Comparator: Healthy Behaviors Control Group

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

    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.
    Other Names:
  • HBC
  • Outcome Measures

    Primary Outcome Measures

    1. Motivation and Pleasure Scale (MAP) [5 months]

      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.

    2. Goal Attainment Scaling (GAS) [5 months]

      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.

    Secondary Outcome Measures

    1. Heinrich's Quality of Life Scale (QLS) [5 months]

      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.

    Other Outcome Measures

    1. Barkley Deficits in Executive Functioning Scale - Short Form (BDEFS-SF) [5 months]

      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.

    2. Specific Levels of Functioning (SLOF) [5 months]

      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.

    3. Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) [5 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York State Office of Mental Health New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Alice Saperstein, PhD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alice Saperstein, PhD, Assistant Professor of Medical Psychology, Columbia University
    ClinicalTrials.gov Identifier:
    NCT05805397
    Other Study ID Numbers:
    • 8394-2
    • 1R34MH129552-01A1
    First Posted:
    Apr 10, 2023
    Last Update Posted:
    Apr 10, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alice Saperstein, PhD, Assistant Professor of Medical Psychology, Columbia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 10, 2023