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

Purpose

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.

Conditions

  • Schizophrenia
  • Schizoaffective Disorder

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
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
Primary Purpose
Treatment
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.

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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 names:
    • CT

More Details

Status
Active, not recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

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.