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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Adaptation Training
Community Treatment
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cognitive Adaptation Training, Functional Outcome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • United Services Inc.
  • Henderson Behavioral Health
  • Chestnut Health Systems
  • Community Mental Health Center Inc.
  • Mental Health Center of Greater Manchester
  • Peace Health
  • Providence Center
  • The Harris Center for Mental Health & IDD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Adaptation Training

Community Treatment

Arm Description

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.

Medication follow-up and case management as provided by the community mental health center according to usual care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
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.
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.
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.

Full Information

First Posted
January 28, 2019
Last Updated
August 17, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Vanguard Research Group, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03829280
Brief Title
Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)
Acronym
CAT-EM
Official Title
Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Vanguard Research Group, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Cognitive Adaptation Training, Functional Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster Randomized clinical trial conducted at 8 community mental health outpatient treatment sites across the country
Masking
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.
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Adaptation Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Community Treatment
Arm Type
Active Comparator
Arm Description
Medication follow-up and case management as provided by the community mental health center according to usual care.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Adaptation Training
Other Intervention Name(s)
CAT
Intervention Description
Psychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior
Intervention Type
Behavioral
Intervention Name(s)
Community Treatment
Other Intervention Name(s)
CT
Intervention Description
Medication follow-up and case management as provided in usual community care in the setting
Primary Outcome Measure Information:
Title
Change in Social and Occupational Functioning Scale Scores
Description
A rating from 0-100 reflecting global level of Social and Occupational functioning; Higher scores indicate better functioning.
Time Frame
baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change in Daily activity
Description
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)
Time Frame
baseline, 6 months, 12 months
Title
Change in Multnomah Community Ability Scale mean score
Description
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.
Time Frame
baseline, 6 months, 12 months
Title
Change in Adherence Estimate Score
Description
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.
Time Frame
baseline, 6 months, 12 months
Title
Change in Negative Symptom Assessment-16 Mean Score
Description
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.
Time Frame
baseline, 6 months, 12 months
Title
Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score
Description
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.
Time Frame
baseline, 6 months, 12 months
Other Pre-specified Outcome Measures:
Title
Change in Effort Expenditure for Rewards Task (EEfRT) Probability Difference score
Description
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%)
Time Frame
baseline, 6 months, 12 months
Title
Change in global score of Brief Assessment of Cognition (BACS) App
Description
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.
Time Frame
baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Velligan, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
United Services Inc.
City
Dayville
State/Province
Connecticut
ZIP/Postal Code
06241
Country
United States
Facility Name
Henderson Behavioral Health
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Chestnut Health Systems
City
Granite City
State/Province
Illinois
ZIP/Postal Code
62040
Country
United States
Facility Name
Community Mental Health Center Inc.
City
Lawrenceburg
State/Province
Indiana
ZIP/Postal Code
47025
Country
United States
Facility Name
Mental Health Center of Greater Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03101
Country
United States
Facility Name
Peace Health
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Providence Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
The Harris Center for Mental Health & IDD
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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