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

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ClinicalTrials.gov Identifier: NCT03829280
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : May 3, 2019
Sponsor:
Collaborators:
Vanguard Research Group
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Behavioral: Cognitive Adaptation Training Behavioral: Community Treatment Not Applicable

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.

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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 15, 2019
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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%)

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Dawn I Velligan, PhD 2105675508 velligand@uthscsa.edu
Contact: Marina S Robertson, LPC 2105675508 robertsonm1@uthscsa.edu

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

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03829280     History of Changes
Other Study ID Numbers: HSC20180237H
1R01MH117101-01 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: January 2019
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Texas Health Science Center at San Antonio:
Schizophrenia
Cognitive Adaptation Training
Functional Outcome

Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders