Motivation Skills Training to Enhance Functional Outcomes for People With Schizophrenia (Open Trial)
Phase: NA
Conditions: Schizophrenia, Schizoaffective Disorder
Sponsor: Columbia University

Study Title: Motivation Skills Training for Schizophrenia 
 
Clinicaltrials.gov: NCT05746455 
 
Study Protocol 
 
Date of Approval: 12/23/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protocol Information: 
 
IRB of Record: New York State Psychiatric Institute (subsequently transferred to Columbia 
University) 
Protocol # 8394 
First Date of IRB Approval: 12/23/2022 
 
Contact Principal Investigator: Alice Saperstein, PhD  
Co-Investigator(s): Alice Medalia, PhD 
NYSPI PI Division: Behavioral Health Services and Policy Research 
 
Source of Funding: Federal  
Institute/Agency: National Institute of Mental Health  
Grant Name: Motivation Skills Training to Enhance Functional Outcomes for People with 
Schizophrenia 
Grant Number: R34 MH129552-01A1 
 
Background, Significance and Rationale: 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. The processes by which 
individuals identify, monitor, and control their motivational states in service of their goals are 
collectively known as metamotivation. We developed a group-based intervention, Motivation 
Skills Training (MST) by drawing from the motivation-science literature and strategies employed 
in educational settings that teach students to self-regulate motivation and thereby improve 
academic performance. Pilot data support the efficacy and acceptability of MST, which provides 
training in strategies to self-motivate in order to enhance the initiation of and persistence in goal- 
directed activities. This proposal takes the next steps to address three key questions: 
1. Is MST, a group-based motivation skills intervention, feasible and acceptable for people with 
schizophrenia attending outpatient community mental health clinics? 
2. Do people with schizophrenia who participate in MST demonstrate increased motivation to 
engage in goal-directed behaviors? 
3. Does the addition of MST to existing recovery-oriented services improve functional 
outcomes? 
Purpose: Facilitate a scalable approach to treating motivation impairment in people with 
schizophrenia spectrum disorders. Quantitative outcomes and qualitative data gathered from 
service recipients and providers during an open trial of MST in an outpatient community clinic 
will inform refinements to treatment parameters and content to improve target engagement, 
acceptability, and clinical utility.  
 
Study Locations: New York State Office of Mental Health licensed outpatient community clinic.  
 
Description of Subject Population: The study sample includes adults with schizophrenia and 
schizoaffective disorder age 18-65 receiving routine services.  
 
 

Procedures: This is an open trial of MST taking place in one outpatient mental health clinic with 
1-2 licensed mental health clinicians providing MST. Clients receiving an array of group-based 
outpatient services are asked if they would like to learn more  about MST and about research.  
Interested clients are referred to a trained member  of the study team for additional information, 
informed consent and eligibility screening according to inclusion/exclusion criteria. Through 
these procedures, the goal is to enroll 10 participants who are adults with a DSM-5 diagnosis of 
schizophrenia or schizoaffective disorder, age 18-65, fluent in English, and medically and 
psychiatrically stable. For those who consent for research, eligible participants undergo baseline 
assessment including sociodemographic and psychosocial data and structured measures of 
motivation and goal attainment. MST occurs in weekly, small group 90-minute sessions over the 
span of 12- 14 weeks. Participants may remain engaged in a variety of outpatient services 
ranging from individual psychotherapy and medication management, to supported employment. 
There are no change to these treatments as usual. Each MST session entails (1) 
psychoeducation to introduce motivation knowledge and self-regulation skills, (2) individualized 
goal setting and progress tracking, (3) group workshopping around skill applications and 
supports. Individualized goal setting and weekly review of goal progress provides the context for 
identifying what factors are positively or negatively impacting one’s motivation and for directly 
applying motivation knowledge and skills. Research participants including those who exit early 
from MST and MST graduates, are asked to complete a satisfaction questionnaire that asks 
about the acceptability of the assessment procedures and whether MST sessions were found to 
be helpful for self- motivation, steps toward goal attainment, and functioning in day-to-day life. 
Additional questions will ascertain the benefits and challenges to completing sessions. 
Participants will be asked to repeat measures of motivation, goals, symptom severity, and 
functioning. Data summarized from pre-post assessments, satisfaction evaluation, and feedback 
will be used to refine the assessment protocol, treatment parameters, skills training content and 
the structure of the treatment manual. 
 
Informed Consent:  The process of informed consent occurs in-person at the recruitment site 
where individuals are receiving their mental health services. All who agree to an initial meeting 
with research personnel have the full study explained  to them and have ample opportunity to 
ask questions prior to signing consent. The process of informed consent includes explanation of 
the amount of time required, the possible risks and benefits of study participation, their right to 
refuse participation in the study without prejudice and alternatives to study participation, their 
right to terminate participation at any moment without prejudice, procedures to protect 
confidentiality, and the contact information for the PI and IRB. The risks of travel for in-person 
visits during COVID-19 is discussed. A consent  procedure note documents this. The consent 
process includes discussion of the possibility for remote research procedures if completion of 
certain components of the protocol in-person (e.g. interviews) is no longer possible. This 
discussion describes the HIPAA-compliant platforms to be used and any concerns the potential 
participant may have, such as access to a private space, access at home to adequate devices, 
cell signal, or wifi. The consent note documents this discussion. 
 
The research team uses additional safeguards during the consent process to ascertain capacity 
by asking and assessing responses to the following questions: 
1. Do you have to participate in this study? 
2. Can you describe some things you would be asked to do if you participate in this study? 
3. Can you tell me one risk that is involved when participating in research? 
4. Can you tell me how we protect your privacy (i.e. keep your personal information confidential)? 
5. What should you do if you are uncomfortable or want to stop participating in an activity that is 
part of the research? 
6. If you decide not to participate, will your treatment at this clinic be affected? 

A list of possible correct answers is provided to the researcher performing this assessment. 
Incorrect responses are immediately addressed to clarify the information and the question is 
asked again to ensure that clients understand the information provided. If the client’s capacity is 
in question, the referring clinician is consulted. A progress note in the research chart documents 
the process of informed consent and the results of the capacity assessment conducted by the 
member of the research team. 
 
Eligibility: 
 
CRITERION 
METHOD OF ASCERTAINMENT 
Inclusion: 
1. Age 18-65 
1. Client report of DOB, checked by Chart 
Review 
2. A primary DSM-5 diagnosis of schizophrenia or 
schizoaffective disorder 
3. Medically and psychiatrically stable  outpatient 
status 
2. Referral Source or Chart Review, 
confirmed by structured clinical interview 
(SCID-5)  
3. Referral Source or Chart Review, 
confirmed by C- SSRS 
4. English Fluency 
4. Observation during Informed Consent, 
checked by Test of Premorbid Functioning 
(TOPF) 
Exclusion: 
1. Indications of Intellectual Disability as 
documented in medical history or measured by < 
70 premorbid Full Scale IQ 
1. Referral Source, Medical history, 
confirmed by TOPF 
 
Criteria for Early Discontinuation: Criteria for early discontinuation follow clinic-based 
guidelines. A person is discontinued from a service if they are no longer able to attend at the 
expected rate of weekly sessions due to scheduling conflicts (e.g. work/school), hospitalization 
for medical or substance use treatment, inpatient psychiatric hospitalization, or discharged from 
the clinic. The clinicians use clinical judgment as to the appropriateness of continued 
participation for each person, taking into account evidence of clinical worsening, suicidality, or 
other  issues that may arise during participation. Consultation with the PI will be sought through 
routine supervision prior to discontinuation. No additional criteria will be used for research 
purposes. 
 
Assessment Measures:  
 
Structured Screening Assessments: (1) The Structured Clinical Interview for DSM 5 (SCID-5) is 
used to confirm a chart diagnosis of schizophrenia or schizoaffective disorder and screen out 
severe substance use in the past 3 months. (2) The Test of Premorbid Functioning (TOPF)  
estimates premorbid intellectual functioning. Inclusion requires an estimated Full Scale IQ of ≥ 
70. (3) The Columbia-Suicide Severity Rating Scale (C-SSRS) is administered to assess risk 

and psychiatric stability. Screening assessments take about 30 minutes in total to complete. (4) 
The Mini Mental Status Exam (MMSE) is used only in participants age 60 and older to rule out 
mild to severe cognitive impairment associated with possible dementia. 
Sociodemographic and Psychosocial Data: At baseline, sociodemographic data includes racial 
and ethnic identification, gender identity, age, and educational attainment. Psychosocial data 
includes illness onset and chronicity, current independent living and employment status. These 
data take about 10 minutes to obtain. 
Outcome Measures: Baseline and post-treatment assessments include measures of motivation, 
goal attainment and community functioning.  
 
Motivation: The Motivation and Pleasure (MAP) subscale of the Clinical Assessment Interview 
for Negative Symptoms (CAINS) is used to assess the intervention target, motivation. The 
CAINS was developed utilizing recommendations from the NIMH-MATRICS Consensus 
Development Conference on Negative Symptoms. The MAP is a 9-item clinical interview which 
examines motivation, pleasure, and engagement in work, school, recreational and social 
activities. The MAP scale is reliable and has been shown to be correlated with real-world 
functioning and self-rated quality of life. This measure will take about 20 minutes to complete. 
Average MAP item score at baseline will be used to stratify participants by degree of motivation 
deficit (≥2 moderate-severe vs <2 mild) within each clinic for randomization. Change in total 
MAP score is the primary outcome. 
 
Functional Outcomes: (1) The primary functional outcome is goal attainment using Goal 
Attainment Scaling (GAS), a standardized, ecologically valid method of measuring the extent to 
which a participant’s recovery goals are achieved in the course of intervention. Individualized 
goal setting is a routine part of rehabilitation and recovery services and progress towards goal 
attainment is a sensitive and specific person- centered outcome measure. On the GAS goals 
are individually identified and anchor points along a continuum of a “successful outcome” are 
established a priori. We use a scoring method derived from previous research which has shown 
sensitivity to change in a clinical trial targeting psychosocial functioning in adults with serious 
mental illness. This measure takes about 20 minutes to complete. (2) The secondary functional 
outcome measure is the Heinrichs Carpenter Quality of Life Scale (QLS), an interviewer-rated 
measure of psychosocial functioning on four domains: interpersonal functioning; intrapsychic 
foundations, instrumental role function, and common objects/activities. This measure takes 
about 20 minutes to complete. 
 
Research Related Delay to Treatment: There is no research related delay to treatment. 
 
Clinical Treatment Alternatives: Individuals who do not participate in research have all 
treatment options at the clinic where they receive outpatient services made available to them. 
Participants can decline involvement in the protocol at any time. 
Risks/Discomforts/Inconveniences: Research participation & confidentiality: The study is 
conducted with individuals with schizophrenia-spectrum disorders who are referred for skills 
training through collaborative decision making with their treating clinician, and therefore have a 
pre-determined capacity to take part in decisions about their treatment. Because the procedures 
and intervention strategies are considered no more than minimal or standard risk, the 
designated population has capacity to consent to participate in research. The greatest risk 
involved in this study is loss of confidentiality as sensitive information (e.g., diagnosis, 
symptoms) will be collected for research. However, all health information collected for research 

is de-identified. Methods to protect confidentiality are described in the next section. 
Assessments: Goal setting, psychiatric symptom and functional assessment measures are 
commonly used in psychiatric treatment contexts including the outpatient facilities where this 
study will take place. Some participants may find the interviews tiring. Some participants may 
become uncomfortable talking about their psychiatric symptoms. Extra precautions to ensure 
that no person is overwhelmed will include: (1) offering breaks, (2) offering refreshments, and 
(3) dividing the assessment session if feasible. The voluntary nature of 
participating in research procedures will be emphasized as needed. 
 
Intervention: Skills training and psychoeducation are an integral component of recovery-oriented 
psychosocial  services for people with serious and persistent mental illness such as those 
diagnosed with a schizophrenia spectrum disorder. We therefore expect that participants will be 
able to engage in the skill learning activities and do not anticipate any undue burden to 
participants during either intervention. Although there are no anticipated risks as a function of 
MST, given that the sample involves people with psychotic disorders, and that people may 
struggle with motivation specifically, special attention is devoted  to minimizing perceived 
burden, stress, and ensuring participant safety. The clinicians facilitating the intervention 
sessions are specialists in providing behavioral interventions to this population and are attentive 
to signs of burden, stress, or fatigue. Breaks during treatment sessions are offered as needed. 
Session attendance is tracked; participants discuss progress and troubleshoot barriers to 
participation with the treating clinician on a weekly basis. The relevance of skill learning (to 
enhance motivation or to enhance health and well-being) to everyday life is a focus of the 
intervention. The content of the intervention and the style of intervention delivery is sensitive to 
the experience of barriers to treatment engagement. Importantly, therapeutic content and skills 
training techniques are designed to support individuals’ sense of competency, autonomy, create 
a sense of relatedness among group members and clinicians, which are all factors associated 
with treatment engagement and learning success. Helping participants to recognize the value 
and to create personal meaning promote engagement and minimize stress. 
Necessary or requested treatment for psychosis and other disorders: Participation in this study 
does not alter clinical treatment for psychosis or other disorders (e.g., medication management, 
skills training) as designated by the treatment team. Changes in mental status that coincide with 
the study would likely be secondary to the course of the illness as opposed to precipitants 
associated with the research protocol. Outpatient treatment teams are trained to handle events 
such as clinical worsening, defined as an increase in symptoms (e.g., hallucinations, paranoia) 
that causes significant distress, poses imminent risk of harm to self or to others, and/or impairs 
the ability of the individual to participate in study procedures. Routine structured assessment 
and management of suicidal behavior and ideation within outpatient treatment is ongoing. When 
immediate emergency intervention is required, whether clinical worsening becomes evident 
during assessment or treatment, the evaluating clinician will determine which of three options is 
indicated: psychiatric evaluation at the nearest Emergency Department, increased monitoring, or 
continued treatment at current level of care. A  safety planning intervention is then invoked. Any 
unanticipated adverse event involving a participant in research will be reported immediately to 
the PI by the appropriate treatment team member. Clinical supervision will allow for routine 
discussion of participants’ clinical stability and ability to continue with treatment sessions. 
 
We further ensure sufficient surveillance of risk by integrating an Independent Safety Monitor 
(ISM) whose role is defined by the funding agency (NIMH). 
 

Methods to Minimize Risk: Procedures associated with potential loss of confidentiality and 
measures to protect confidentiality are listed in the consent form. A HIPAA Authorization form, 
reviewed at the time of informed consent, lists those entities with whom knowledge of 
participation and data may be shared. Hard copy data (e.g., assessment forms) are labeled with 
a unique numerical identifier that does not reference any personal information and are stored in 
a locked cabinet in a locked office accessible only to the research team. Consent forms contain 
identifying information but are not coupled with identification numbers and are kept in a locked file 
drawer in a locked office, separate from hard copy data, accessible only to the PI. A secure 
electronic database in which data is entered is only accessible to the research team. The 
database is created and managed by the Statistical Analysis Center which collaborates with 
Columbia University Irving Medical Center’s IT Security office to certify systems for use as 
secure and reliable repositories for clinical data. Public dissemination of the results and data 
deposited into public repositories will contain no identifying information about individual 
subjects. 
As a federally funded study, there is a Certificate of Confidentiality. 
 
Direct Benefits to Subjects: Participants may or may not learn new information or skills. 
 
Compensation or Reimbursement: Participants in the Open Trial are compensated $40 for 
the baseline assessment and $50 for the post-treatment assessment. 
 
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