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

The University of Texas System (UT)

Status: Completed

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Behavioral: Cognitive Adaptation Training; Behavioral: Community Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03829280

1R01MH117101-01 (U.S. NIH Grant/Contract)

HSC20180237H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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205 participants in 2 patient groups

Cognitive Adaptation Training

Experimental group

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.

Treatment:

Behavioral: Cognitive Adaptation Training

Community Treatment

Active Comparator group

Description:

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

Treatment:

Behavioral: Community Treatment