Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM) (CAT-EM)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Behavioral: Cognitive Adaptation Training; Behavioral: Community Treatment

Detailed Description

Schizophrenia remains one of the most disabling conditions world-wide with an economic burden that exceeded $155 billion dollars in fiscal year 2013 alone. Despite existing medication and community treatment, many individuals with this diagnosis continue to have poor outcomes and struggle toward recovery. CAT is 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, and support habits for functional behavior to promote recovery. In a series of efficacy studies, CAT improved social and occupational functioning, symptoms, and adherence to medication, and reduced rates of readmission. The investigators propose a cluster randomized effectiveness trial comparing Cognitive Adaptation Training (CAT) to existing community treatment (CT) for individuals with schizophrenia in 8 community mental health centers across multiple states including 400 participants. This would be the first large-scale effectiveness study of CAT for improving functional outcomes for those with schizophrenia seen in community mental health centers (CMHCs) where the majority of those with schizophrenia are followed for outpatient care and to study the purported mechanisms of action based on an integrated theoretical model. 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. CAT treatment will be weekly for 6 months, biweekly for 3 months and monthly for the remainder of the trial. Purported mechanisms of action for CAT including bypassing impairments in cognitive function to improve functional outcome and bypassing motivational impairments to create automatic habits to improve functional outcome will be examined.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dawn I Velligan, PhD; Phone Number: 2105675508; Email: velligand@uthscsa.edu
• Study Contact Backup: Name: Feyiu Li, PhD; Phone Number: 2105675594; Email: LiF4@uthscsa.edu

Study Locations

• United States
  • Connecticut
    • Dayville, Connecticut, United States, 06241
      • United Services Inc.
  • Florida
    • Lauderdale Lakes, Florida, United States, 33319
      • Henderson Behavioral Health
  • Illinois
    • Granite City, Illinois, United States, 62040
      • Chestnut Health Systems
  • Indiana
    • Lawrenceburg, Indiana, United States, 47025
      • Community Mental Health Center Inc.
  • New Hampshire
    • Manchester, New Hampshire, United States, 03101
      • Mental Health Center of Greater Manchester
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Peace Health
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Providence Center
  • Texas
    • Houston, Texas, United States, 77074
      • The Harris Center for Mental Health & IDD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males and females who have given informed consent.
2. Between the ages of 18 and 65.
3. Clinical Diagnosis of Schizophrenia, or Schizoaffective Disorder
4. 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.
5. Able to understand and complete rating scales and assessments.
6. Agree to home visits
7. Be able to have reimbursed home visits as part of treatment

Exclusion Criteria:

1. Alcohol or drug or dependence within the past 2 months.
2. Currently being treated by an Assertive Community Treatment (ACT) team.
3. History of assault within the past year or other conditions that in the judgement of the treatment team make home visits unsafe.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Daily activity	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)	baseline, 6 months, 12 months
Change in Multnomah Community Ability Scale mean score	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.	baseline, 6 months, 12 months
Change in Adherence Estimate Score	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.	baseline, 6 months, 12 months
Change in Negative Symptom Assessment-16 Mean Score	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.	baseline, 6 months, 12 months
Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score	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.	baseline, 6 months, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Effort Expenditure for Rewards Task (EEfRT) Probability Difference score	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%)	baseline, 6 months, 12 months
Change in global score of Brief Assessment of Cognition (BACS) App	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.	baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Institute of Mental Health (NIMH); Vanguard Research Group
• Investigators: Principal Investigator: Dawn Velligan, PhD, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Schizophrenia; Functional Outcome; Cognitive Adaptation Training
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: HSC20180237H; 1R01MH117101-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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).
• IPD Sharing Time Frame: 6 mos following publication of the primary outcomes of the study and extending for a period of 2 years
• IPD Sharing Access Criteria: deidentified data only upon email request to PI with specific research questions and analysis plan.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No