Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM) (CAT-EM)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03829280 |
Recruitment Status :
Recruiting
First Posted : February 4, 2019
Last Update Posted : June 21, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia Schizoaffective Disorder | Behavioral: Cognitive Adaptation Training Behavioral: Community Treatment | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Cluster Randomized clinical trial conducted at 8 community mental health outpatient treatment sites across the country |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Raters assessing clinical outcome variables are centralized raters who are blind to treatment group as well as study design and aims. |
Primary Purpose: | Treatment |
Official Title: | Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM) |
Actual Study Start Date : | April 4, 2019 |
Estimated Primary Completion Date : | August 2024 |
Estimated Study Completion Date : | August 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Cognitive Adaptation Training
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, and support habits for functional behavior to promote recovery.
|
Behavioral: Cognitive Adaptation Training
Psychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior
Other Name: CAT |
Active Comparator: Community Treatment
Medication follow-up and case management as provided by the community mental health center according to usual care.
|
Behavioral: Community Treatment
Medication follow-up and case management as provided in usual community care in the setting
Other Name: CT |
- Change in Social and Occupational Functioning Scale Scores [ Time Frame: baseline, 6 months, 12 months ]A rating from 0-100 reflecting global level of Social and Occupational functioning; Higher scores indicate better functioning.
- Change in Daily activity [ Time Frame: baseline, 6 months, 12 months ]Negative Symptom Assessment item 14 assessing typical daily behavior using a structured interview with behavioral anchor points. Scale is rated 1 to 6 with higher scores indicating lower levels of engagement in daily activity (i.e. more severe apathy)
- Change in Multnomah Community Ability Scale mean score [ Time Frame: baseline, 6 months, 12 months ]Assessment of community functioning on a 17 -item scale with domains assessing interference with functioning, adjustment to living, social competence and behavioral problems. Items are averaged to produce a mean score. Items are each rated on a scale from 1-5 with higher scores reflecting better community functioning.
- Change in Adherence Estimate Score [ Time Frame: baseline, 6 months, 12 months ]A 3 item scale assessing variables associated with adherence. Items are rated based upon self report about the importance of taking medication, worry about medication and financial burden of medication on a scale from agree completely to disagree completely. Each answer is assigned points based on an algorithm and added producing a total score. Higher scores indicate a higher risk for adherence and a lower probability of adherence. Scores range for 0 to 100.
- Change in Negative Symptom Assessment-16 Mean Score [ Time Frame: baseline, 6 months, 12 months ]Assesses 16 negative symptoms in the domains of communication, emotion/affect, social activity, motivation and psychomotor activity on a scale from 1-6. Items are added and divided by 16 to produce a mean score. A global score is also produced based upon clinical judgement following the interview Higher scores reflect higher levels of negative symptoms.
- Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score [ Time Frame: baseline, 6 months, 12 months ]24 item scale assessing multiple dimensions of psychopathology including positive symptoms; negative symptoms, anxiety/depression, and activation on a series of 7 point scales. Higher scores reflect higher levels of symptoms.
- Change in Effort Expenditure for Rewards Task (EEfRT) Probability Difference score [ Time Frame: baseline, 6 months, 12 months ]computerized task of effort put forth to win various amounts of money under various levels of probability. The probability difference score equals the percent of hard choices in the high probability condition minus the percent of hard choices in the low probability condition. Higher scores indicate more frequent choices of hard tasks at the high versus low probability level. individuals who answer the same way on all tasks are eliminated (estimate 1%)
- Change in global score of Brief Assessment of Cognition (BACS) App [ Time Frame: baseline, 6 months, 12 months ]Ipad delivered version of BACS assessing memory, attention, executive function and psychomotor speed. Standard scores are generated and summed to create a global cognition score with higher scores indicating better levels of cognitive function.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829280
Contact: Dawn I Velligan, PhD | 2105675508 | velligand@uthscsa.edu | |
Contact: Feyiu Li, PhD | 2105675594 | LiF4@uthscsa.edu |
United States, Connecticut | |
United Services Inc. | Recruiting |
Dayville, Connecticut, United States, 06241 | |
Contact: Sandy Long slong@usmhs.org | |
United States, Florida | |
Henderson Behavioral Health | Recruiting |
Lauderdale Lakes, Florida, United States, 33319 | |
Contact: Elise Ward eward@hendersonbh.org | |
United States, Illinois | |
Chestnut Health Systems | Recruiting |
Granite City, Illinois, United States, 62040 | |
Contact: Jamie Jung jjung@chestnut.org | |
United States, Indiana | |
Community Mental Health Center Inc. | Recruiting |
Lawrenceburg, Indiana, United States, 47025 | |
Contact: Bill Hardy bill.hardy@cmhcinc.org | |
United States, New Hampshire | |
Mental Health Center of Greater Manchester | Recruiting |
Manchester, New Hampshire, United States, 03101 | |
Contact: Sue Guarino guarinos@mhcgm.org | |
United States, Oregon | |
Peace Health | Recruiting |
Eugene, Oregon, United States, 97401 | |
Contact: Coleen Hudkins CHudkins@peacehealth.org | |
United States, Rhode Island | |
Providence Center | Recruiting |
Providence, Rhode Island, United States, 02904 | |
Contact: Tara Zorabedian tzorabedian@carene.org | |
United States, Texas | |
The Harris Center for Mental Health & IDD | Not yet recruiting |
Houston, Texas, United States, 77074 | |
Contact: Scott Hickey Scott.Hickey@TheHarrisCenter.org |
Principal Investigator: | Dawn Velligan, PhD | University of Texas |
Responsible Party: | The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT03829280 |
Other Study ID Numbers: |
HSC20180237H 1R01MH117101-01 ( U.S. NIH Grant/Contract ) |
First Posted: | February 4, 2019 Key Record Dates |
Last Update Posted: | June 21, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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). |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Schizophrenia Cognitive Adaptation Training Functional Outcome |
Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |