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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

Tracking Information
First Submitted Date  ICMJE January 28, 2019
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE April 15, 2019
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03829280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • 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
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2019)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)
Official Title  ICMJE Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE
  • Behavioral: Cognitive Adaptation Training
    Psychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior
    Other Name: CAT
  • Behavioral: Community Treatment
    Medication follow-up and case management as provided in usual community care in the setting
    Other Name: CT
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Cognitive Adaptation Training
  • Active Comparator: Community Treatment
    Medication follow-up and case management as provided by the community mental health center according to usual care.
    Intervention: Behavioral: Community Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dawn I Velligan, PhD 2105675508 velligand@uthscsa.edu
Contact: Marina S Robertson, LPC 2105675508 robertsonm1@uthscsa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03829280
Other Study ID Numbers  ICMJE HSC20180237H
1R01MH117101-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE
  • Vanguard Research Group
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Dawn Velligan, PhD University of Texas
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP