Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)
CAT-EM
2 other identifiers
interventional
205
1 country
8
Brief Summary
The investigators propose a cluster randomized effectiveness trial comparing Cognitive Adaptation Training (CAT; a psychosocial treatment using environmental supports such as signs, alarms, pill containers, checklists, technology and the organization of belongings established in a person's home or work environment to bypass the cognitive and motivational difficulties associated with schizophrenia ) to existing community treatment (CT) for individuals with schizophrenia in 8 community mental health centers across multiple states including 400 participants. Mechanisms of action will be examined. Participants will be assessed at baseline and 6 and 12 months on measures of functional and community outcome, medication adherence, symptoms, habit formation and automaticity, cognition and motivation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Apr 2019
Longer than P75 for not_applicable schizophrenia
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedStudy Start
First participant enrolled
April 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedAugust 9, 2024
July 1, 2023
5.2 years
January 28, 2019
August 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Social and Occupational Functioning Scale Scores
A rating from 0-100 reflecting global level of Social and Occupational functioning; Higher scores indicate better functioning.
baseline, 6 months, 12 months
Secondary Outcomes (5)
Change in Daily activity
baseline, 6 months, 12 months
Change in Multnomah Community Ability Scale mean score
baseline, 6 months, 12 months
Change in Adherence Estimate Score
baseline, 6 months, 12 months
Change in Negative Symptom Assessment-16 Mean Score
baseline, 6 months, 12 months
Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score
baseline, 6 months, 12 months
Other Outcomes (2)
Change in Effort Expenditure for Rewards Task (EEfRT) Probability Difference score
baseline, 6 months, 12 months
Change in global score of Brief Assessment of Cognition (BACS) App
baseline, 6 months, 12 months
Study Arms (2)
Cognitive Adaptation Training
EXPERIMENTALPsychosocial treatment using environmental supports such as signs, alarms, pill containers, checklists, technology and the organization of belongings established in a person's home or work environment to bypass the cognitive and motivational difficulties associated with schizophrenia, and support habits for functional behavior to promote recovery.
Community Treatment
ACTIVE COMPARATORMedication follow-up and case management as provided by the community mental health center according to usual care.
Interventions
Psychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior
Medication follow-up and case management as provided in usual community care in the setting
Eligibility Criteria
You may qualify if:
- Males and females who have given informed consent.
- Between the ages of 18 and 65.
- Clinical Diagnosis of Schizophrenia, or Schizoaffective Disorder
- Able to provide evidence of a stable living environment (individual apartment, family home, board and care facility) within the last three months and no plans to move in the next year.
- Able to understand and complete rating scales and assessments.
- Agree to home visits
- Be able to have reimbursed home visits as part of treatment
You may not qualify if:
- Alcohol or drug or dependence within the past 2 months.
- Currently being treated by an Assertive Community Treatment (ACT) team.
- History of assault within the past year or other conditions that in the judgement of the treatment team make home visits unsafe.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
United Services Inc.
Dayville, Connecticut, 06241, United States
Henderson Behavioral Health
Lauderdale Lakes, Florida, 33319, United States
Chestnut Health Systems
Granite City, Illinois, 62040, United States
Community Mental Health Center Inc.
Lawrenceburg, Indiana, 47025, United States
Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03101, United States
Peace Health
Eugene, Oregon, 97401, United States
Providence Center
Providence, Rhode Island, 02904, United States
The Harris Center for Mental Health & IDD
Houston, Texas, 77074, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dawn Velligan, PhD
University of Texas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Raters assessing clinical outcome variables are centralized raters who are blind to treatment group as well as study design and aims.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Henry B. Dielmann Chair of Psychiatry and Behavioral Sciences
Study Record Dates
First Submitted
January 28, 2019
First Posted
February 4, 2019
Study Start
April 4, 2019
Primary Completion
May 31, 2024
Study Completion
May 31, 2024
Last Updated
August 9, 2024
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 6 mos following publication of the primary outcomes of the study and extending for a period of 2 years
- Access Criteria
- deidentified data only upon email request to PI with specific research questions and analysis plan.
The investigators will be fully compliant with the NIMH Data Archive Data Sharing Terms and Conditions, including submitting and harmonizing all descriptive/raw data and analyzed data generated by the grant at the item and subject-level to the National Database for Clinical Trials (NDCT). All submitted data will include a Global Unique Identifier (GUID) and will not include personally identifiable information (PII).