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.

Category

IRB Number
20180237HU
NCT Number
NCT03829280
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Feiyu Li
lif4@uthscsa.edu

Principal Investigator
Dawn Velligan

Feiyu Li
lif4@uthscsa.edu

Dawn Velligan
(210) 567-5508
velligand@uthscsa.edu



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.
Condition
  • Schizophrenia
  • Schizoaffective Disorder

    • Arm Groups

    ArmDescriptionIntervention
    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

    • 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

    •