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

Schizophrenia Clinical Trial

— CAT-EM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03829280
• Other study ID #: HSC20180237H
• Secondary ID: 1R01MH117101-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 4, 2019
• Est. completion date: April 2025

Study information

• Verified date: July 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 205
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Cognitive Adaptation Training
Psychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior
• Community Treatment
Medication follow-up and case management as provided in usual community care in the setting

Locations

Country	Name	City	State
United States	United Services Inc.	Dayville	Connecticut
United States	Peace Health	Eugene	Oregon
United States	Chestnut Health Systems	Granite City	Illinois
United States	The Harris Center for Mental Health & IDD	Houston	Texas
United States	Henderson Behavioral Health	Lauderdale Lakes	Florida
United States	Community Mental Health Center Inc.	Lawrenceburg	Indiana
United States	Mental Health Center of Greater Manchester	Manchester	New Hampshire
United States	Providence Center	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Institute of Mental Health (NIMH), Vanguard Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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