Enhancing Cognitive and Work/School Outcomes in First Episode Psychosis Using Cognitive Self-Management Strategies
Enhancing Cognitive and Work/School Outcomes in People With First Episode Psychosis: Testing the Effectiveness of Cognitive Self-Management Strategies
The goal of this pilot cluster randomized trial is to understand if adding a standardized cognitive self-management program, Thinking Skills for Work-Cognitive Self-Management Strategies (CSM) to Coordinated Specialty Care Supported Employment and Education (SEE) programs improves the work and school outcomes of young adults experiencing first episode psychosis. The main questions it aims to answer are:
- Does adding the CSM program to usual SEE services lead to improved work and school outcomes, such as ability to find a job or enroll in school, or ability to keep a job or stay in school?
- Does adding the CSM program to usual SEE services improve cognition and cognitive self-efficacy? Researchers will recruit six research sites and these will be randomized to either treatment as usual, where they will offer regular SEE services, or the experimental groups, where they will offer regular SEE services plus the CSM program.
Participants in both groups will be asked to complete a brief assessment at baseline, 6-months, 12-months, and 18-months. Participants in the experimental group will be asked to participate in the 12-session CSM program in addition to their regular SEE services.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The Coordinated Specialty Care (CSC) programs in the EPINET-TX Network provide Supported Employment and Education (SEE) services for young adults between the ages of 15-32 experiencing first episode psychosis (FEP). In this pilot cluster randomized clinical trial (RCT), six CSC programs representing different geographical regions including the urban southwest (serving a majority Latino population), the urban central and southeast (serving majority African American population), and the rural north and northeast (serving a racially/ethnically mixed population) that are part of the EPINET-TX Network will be recruited. Once the 6 SEE teams have been recruited, they will be randomized using a stratified procedure based on geographic region and populations served.
The 3 SEE teams randomized to the experimental group will be trained in CSM by the Boston University (BU) research team. During the training period, the CSC team program director and SEE specialist will be trained in CSM resources and methods, beginning with an online self-paced training course, followed by weekly and then biweekly zoom-based group supervision with BU researchers. CSM sessions will be audio-recorded as part of initial training and ongoing fidelity checks. Zoom meeting training sessions will also be recorded. CSM training is expected to take approximately three months, and the participating SEE programs will be reimbursed for staff training time. Designated site CSC personnel from both the experimental and the control group sites will be trained to administer the outcome assessments.
After training of CSC teams and assessors is complete, recruitment of young adults with FEP will begin at all 6 sites simultaneously. Recruitment of young adult participants will include information meetings conducted by the program directors of participating CSC programs, consent and assent meetings, and the baseline assessment. Once identified, these program directors will be added as staff on the Institutional Review Board (IRB).
The 6 CSC teams will then administer either the experimental intervention (CSM + SEE) intervention or the control intervention (SEE only). Staff within the experimental group will continue to receive support from the BU PI's, who will periodically administer the CSM Fidelity Scale to ensure CSM intervention fidelity.
Young adult participants in both the experimental and control groups will complete assessments at baseline, 6 months, 12 months, and 18 months. These assessments will take place in person by a trained onsite assessor. The baseline assessment battery will include a demographics questionnaire, history of employment and education questionnaire, the WRAT to assess reading level, and 2 cognitive assessments (described below). Follow-up assessments will only include the cognitive measures. These assessments are expected to take between 60-90 minutes for a total of 6 hours of time.
In addition, research sites will share the results of the Core Assessment Battery (CAB), an assessment that is administered as a part of routine CSC care every six months, with the BU researchers every 6 months. Additional information about prescribed medication, SEE program utilization, and psychiatric hospitalizations is normally collected quarterly and will be shared at each assessment. Education and employment logs will be collected weekly and shared with the BU research team. This information will be collected on all young adult participants.
Young adults with FEP in the experimental group will participate in the CSM intervention. The teaching of Cognitive Self-Management Strategies (CSM) by SEE specialists includes an additional 12 sessions that range from 45 to 60 minutes long. Thus, participants in the experimental group will complete about 18 hours of study activities over an 18-month period. Those in the control group will participate in the assessments, about 6 hours of study activities over an 18-month period.
After the study is over, participants from the control group still enrolled in the CSC program will be offered CSM if appropriate to their goals.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Susan R McGurk, PhD
- Número de teléfono: 617-353-3549
- Correo electrónico: mcgurk@bu.edu
Copia de seguridad de contactos de estudio
- Nombre: Alexa Trolley-Hanson, MS
- Número de teléfono: 617-353-3549
- Correo electrónico: athanson@bu.edu
Ubicaciones de estudio
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Texas
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Big Spring, Texas, Estados Unidos, 79720
- Reclutamiento
- West Texas Centers Promoting Behavioral and Developmental Health
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Contacto:
- Monique Gusman
- Número de teléfono: 1-800-852-2193
- Correo electrónico: monique.gusman@wtcmhmr.org
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Investigador principal:
- Amanda Ryan, PhD
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Granbury, Texas, Estados Unidos, 76048
- Reclutamiento
- Pecan Valley Centers for Behavioral and Developmental Healthcare
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Contacto:
- David Risner
- Número de teléfono: 817-579-4400
- Correo electrónico: drisner@pecanvalley.org
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Contacto:
- Amanda Ryan, PhD
- Correo electrónico: amanda.ryan@austin.utexas.edu
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Investigador principal:
- Molly Lopez, PhD
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Laredo, Texas, Estados Unidos, 78041
- Reclutamiento
- Border Region Behavioral Health Care
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Contacto:
- Amanda Ryan, PhD
- Correo electrónico: amanda.ryan@austin.utexas.edu
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Investigador principal:
- Molly Lopez, PhD
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Contacto:
- Janie Hernandez
- Número de teléfono: 956-794-3178
- Correo electrónico: sanjuanah@borderregion.org
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Longview, Texas, Estados Unidos, 75604
- Aún no reclutando
- Community Healthcore
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Investigador principal:
- Amanda Ryan, PhD
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Investigador principal:
- Molly Lopez, PhD
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Contacto:
- Jaime Jaggers
- Número de teléfono: 903-237-2326
- Correo electrónico: Jaime.Jaggers@CommunityHealthcore.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- currently in their first 18 months of enrollment in the CSC program
- at least 15 years of age
- receiving SEE services but not employed or enrolled in school
- have the desire to work or resume school.
Exclusion Criteria:
1) Young adults who are not fluent in english
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: CSM plus SEE Group
The 3 sites (30 participants) from this site will receive the standardized 12 session CSM program in addition to regular SEE services.
The CSM sessions will occur weekly and last between 45-60 minutes.
They cover 12 different areas of cognition such as self-assessment, recognizing strengths, challenging negative thinking, attention and concentration, memory organization, planning ahead, problem-solving, and thinking speed.
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CSM is a 12-session program that promotes the development of specific cognitive strategies to promote success in employment and education outcomes.
This is a standardized, evidence-based intervention with adults with serious mental illness.
Each session is facilitated by a trained cognitive specialist and lasts between 45- 60 minutes.
Session topics include self-assessment of cognitive skills, recognizing strengths, challenging negative thoughts, attention and concentration, memory, organization, planning, and thinking ahead.
In this intervention, participants receive regular weekly Supported Education and Employment (SEE) services.
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Comparador activo: Treatment as Usual
In this arm, the 3 sites (30 participants) will participate in regular weekly SEE services.
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In this intervention, participants receive regular weekly Supported Education and Employment (SEE) services.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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School and Education Activity Tracker
Periodo de tiempo: Tracked weekly through study completion (about 18 months)
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This qualitative measure tracks the participant's participation in education or employment activities on a weekly basis.
It includes questions about the education or employment activity and the time spent completing the activity.
The minimal value is 0, there is no maximum value.
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Tracked weekly through study completion (about 18 months)
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The Cognitive Problems and Strategies Assessment
Periodo de tiempo: Baseline, 6-, 12-, and 18-months
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Standardized measure that assesses cognitive functioning and strategy use.
It includes two subscales, the "Cognitive Problems Subscale" and the "Strategy Use Subscale", each consisting of 30 items that are scored from 0-3 (cumulative 0-90).
A higher score on the Cognitive Problems Subscale indicates a worse outcome, whereas higher scores on the Strategy Use Subscale indicate better outcomes.
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Baseline, 6-, 12-, and 18-months
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Cognitive Self-Efficacy Scale
Periodo de tiempo: Baseline, 6-, 12-, and 18-months
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Standardized measure that assesses an individual's confidence in everyday cognitive tasks.
This is a 10 item scale with values ranging from 0 to 100, with higher values indicating better outcomes.
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Baseline, 6-, 12-, and 18-months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Clinical Outcomes in Measurement-based care Assessment of Symptoms and Severity (COMPASS-10)
Periodo de tiempo: baseline, 6-, 12-,18-months
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This 10-item clinician-rated instrument evaluates positive, negative, and affective symptom severity for individuals experiencing early-phase or first-episode psychotic disorders.
Rated on a scale from 0 (not present) to 6 (very severe).
Lower values indicate treatment progress in this study.
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baseline, 6-, 12-,18-months
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The Global Functioning Social and Role Subscales
Periodo de tiempo: Baseline, 6-, 12-, 18-months
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This 2 item scale measure was designed for young adults and measures a participant's social connections and daily responsibilities.
This clinician-rated scale is scored from 1 to 10, where higher numbers indicate better outcomes.
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Baseline, 6-, 12-, 18-months
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The Personal Wellbeing Index
Periodo de tiempo: Baseline, 6-, 12-, and 18- months
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This is a self-report, 8-item scale, that measures life satisfaction across standard of living, personal health, and relationships.
Scores range from 0 (low-wellbeing) to 10 (high-wellbeing).
Higher scores indicate better outcomes in this study.
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Baseline, 6-, 12-, and 18- months
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The Alcohol Use Scale
Periodo de tiempo: Baseline, 6-, 12-, and 18-months
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This study uses 1 item from this scale, "Please rate your worst 1 month over the past 6 months." Participants report the following ratings:
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Baseline, 6-, 12-, and 18-months
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The Drug Use Scale
Periodo de tiempo: Baseline, 6-, 12-, and 18-months
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This 1-item self-report scale measures a participant's drug use over the past 6 months. Participants report the following ratings:
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Baseline, 6-, 12-, and 18-months
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Substance Use Abuse Treatment Stage
Periodo de tiempo: Baseline, 6-, 12-, and 18-months
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This 1 item scale measures the extent to which a participant is engaged in treatment for their substance use. It is a self-report scale in which the participant chooses one of the following options:
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Baseline, 6-, 12-, and 18-months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Demographics Form
Periodo de tiempo: Baseline only
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Standardized set of questions about a participants age, gender, race/ethnicity, gender, and diagnosis
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Baseline only
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History of employment and education
Periodo de tiempo: Baseline only
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Standardized set of questions about an individual's past employment and education activities
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Baseline only
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susan R McGurk, PhD, Boston University Center for Psychiatric Rehabilitation
- Investigador principal: Kim Mueser, PhD, Boston University Center for Psychiatric Rehabilitation
Publicaciones y enlaces útiles
Publicaciones Generales
- McGurk SR, Mueser KT, Xie H, Bloch P, DeTore NR, Pashka N, Guarino S, Ruiz A, Elliot C, Gagnon H, Bailey E, Fraser V, Welsh J, Cunningham H, Rizzano L, Wolfe R, Drake RE. A dismantling study of comprehensive cognitive remediation for improving employment outcomes: what is the role of computer cognitive training? Psychol Med. 2025 Jul 22;55:e208. doi: 10.1017/S0033291725100986.
- McGurk, S. R., & Mueser, K. T. (2021). Cognitive Remediation for Successful Employment and Psychiatric Recovery: The Thinking Skills for Work Program. Guilford Press.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 7734E
- 90RTEM0004 (Otro número de subvención/financiamiento: Nat. Institute on Disability Indep. Living and Rehab Research)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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