Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Schizoaffective Disorder
  • Schizophrenia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Cluster Randomized clinical trial conducted at 8 community mental health outpatient treatment sites across the countryMasking: 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

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 rec...

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.

Tracking Information

NCT #
NCT03829280
Collaborators
  • Vanguard Research Group
  • National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Dawn Velligan, PhD University of Texas