Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Enrollment
- 205
- Locations
- 8
- Primary Endpoint
- Change in Social and Occupational Functioning Scale Scores
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Dawn Velligan
Henry B. Dielmann Chair of Psychiatry and Behavioral Sciences
The University of Texas Health Science Center at San Antonio
Eligibility Criteria
Inclusion Criteria
- •Males and females who have given informed consent.
- •Between the ages of 18 and
- •Clinical Diagnosis of Schizophrenia, or Schizoaffective Disorder
- •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.
- •Able to understand and complete rating scales and assessments.
- •Agree to home visits
- •Be able to have reimbursed home visits as part of treatment
Exclusion Criteria
- •Alcohol or drug or dependence within the past 2 months.
- •Currently being treated by an Assertive Community Treatment (ACT) team.
- •History of assault within the past year or other conditions that in the judgement of the treatment team make home visits unsafe.
Outcomes
Primary Outcomes
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 Outcomes
- Change in Multnomah Community Ability Scale mean score(baseline, 6 months, 12 months)
- Change in Daily activity(baseline, 6 months, 12 months)
- Change in Adherence Estimate Score(baseline, 6 months, 12 months)
- Change in Negative Symptom Assessment-16 Mean Score(baseline, 6 months, 12 months)
- Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score(baseline, 6 months, 12 months)