Clinical trial NCT03829280: Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)
Official title: Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Cognitive Adaptation Training
Functional Outcome
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Vanguard Research Group
name: National Institute of Mental Health (NIMH)
First posted: 2019-02-04
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized clinical trial conducted at 8 community mental health outpatient treatment sites across the country
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Social and Occupational Functioning Scale Scores
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: Change in Daily activity
timeFrame: baseline, 6 months, 12 months
measure: Change in Multnomah Community Ability Scale mean score
timeFrame: baseline, 6 months, 12 months
measure: Change in Adherence Estimate Score
timeFrame: baseline, 6 months, 12 months
measure: Change in Negative Symptom Assessment-16 Mean Score
timeFrame: baseline, 6 months, 12 months
measure: Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score
timeFrame: baseline, 6 months, 12 months
Other outcomes:
measure: Change in Effort Expenditure for Rewards Task (EEfRT) Probability Difference score
timeFrame: baseline, 6 months, 12 months
measure: Change in global score of Brief Assessment of Cognition (BACS) App
timeFrame: baseline, 6 months, 12 months
Locations:
city: Dayville
country: United States
facility: United Services Inc.
state: Connecticut
city: Lauderdale Lakes
country: United States
facility: Henderson Behavioral Health
state: Florida
city: Granite City
country: United States
facility: Chestnut Health Systems
state: Illinois
city: Lawrenceburg
country: United States
facility: Community Mental Health Center Inc.
state: Indiana
city: Manchester
country: United States
facility: Mental Health Center of Greater Manchester
state: New Hampshire
city: Eugene
country: United States
facility: Peace Health
state: Oregon
city: Providence
country: United States
facility: Providence Center
state: Rhode Island
city: Houston
country: United States
facility: The Harris Center for Mental Health & IDD
state: Texas
Study officials:
affiliation: University of Texas
name: Dawn Velligan, PhD
role: PRINCIPAL_INVESTIGATOR
References: