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

NCT ID: NCT03829280

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-04
• Study Completion Date: 2024-05-31

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Adaptation Training

Intervention Type: BEHAVIORAL

Psychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior

Community Treatment

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

Group Type: ACTIVE_COMPARATOR

Community Treatment

Intervention Type: BEHAVIORAL

Medication follow-up and case management as provided in usual community care in the setting

Interventions

Cognitive Adaptation Training

Psychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior

Intervention Type: BEHAVIORAL

Community Treatment

Medication follow-up and case management as provided in usual community care in the setting

Intervention Type: BEHAVIORAL

Other Intervention Names

CAT; CT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanguard Research Group

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Dawn Velligan

Henry B. Dielmann Chair of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn Velligan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

United Services Inc.

Dayville, Connecticut, United States

Henderson Behavioral Health

Lauderdale Lakes, Florida, United States

Chestnut Health Systems

Granite City, Illinois, United States

Community Mental Health Center Inc.

Lawrenceburg, Indiana, United States

Mental Health Center of Greater Manchester

Manchester, New Hampshire, United States

Peace Health

Eugene, Oregon, United States

Providence Center

Providence, Rhode Island, United States

The Harris Center for Mental Health & IDD

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01MH117101-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC20180237H

Identifier Type: -

Identifier Source: org_study_id