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Completed

NCT Number: NCT03829280

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United Services Inc., Dayville, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females who have given informed consent.
  • Between the ages of 18 and 65.
  • 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.

Treatment and study plan

Cognitive Adaptation Training

Behavioral

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

Other names: CAT

Community Treatment

Behavioral

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

Other names: CT

Primary outcomes

  1. 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

  1. Change in Daily activity

    Time frame: baseline, 6 months, 12 months

    Negative Symptom Assessment item 14 assessing typical daily behavior using a structured interview with behavioral anchor points. Scale is rated 1 to 6 with higher scores indicating lower levels of engagement in daily activity (i.e. more severe apathy)

  2. Change in Multnomah Community Ability Scale mean score

    Time frame: baseline, 6 months, 12 months

    Assessment of community functioning on a 17 -item scale with domains assessing interference with functioning, adjustment to living, social competence and behavioral problems. Items are averaged to produce a mean score. Items are each rated on a scale from 1-5 with higher scores reflecting better community functioning.

  3. Change in Adherence Estimate Score

    Time frame: baseline, 6 months, 12 months

    A 3 item scale assessing variables associated with adherence. Items are rated based upon self report about the importance of taking medication, worry about medication and financial burden of medication on a scale from agree completely to disagree completely. Each answer is assigned points based on an algorithm and added producing a total score. Higher scores indicate a higher risk for adherence and a lower probability of adherence. Scores range for 0 to 100.

  4. Change in Negative Symptom Assessment-16 Mean Score

    Time frame: baseline, 6 months, 12 months

    Assesses 16 negative symptoms in the domains of communication, emotion/affect, social activity, motivation and psychomotor activity on a scale from 1-6. Items are added and divided by 16 to produce a mean score. A global score is also produced based upon clinical judgement following the interview Higher scores reflect higher levels of negative symptoms.

  5. Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score

    Time frame: baseline, 6 months, 12 months

    24 item scale assessing multiple dimensions of psychopathology including positive symptoms; negative symptoms, anxiety/depression, and activation on a series of 7 point scales. Higher scores reflect higher levels of symptoms.

Other outcomes

  1. Change in Effort Expenditure for Rewards Task (EEfRT) Probability Difference score

    Time frame: baseline, 6 months, 12 months

    computerized task of effort put forth to win various amounts of money under various levels of probability. The probability difference score equals the percent of hard choices in the high probability condition minus the percent of hard choices in the low probability condition. Higher scores indicate more frequent choices of hard tasks at the high versus low probability level. individuals who answer the same way on all tasks are eliminated (estimate 1%)

  2. Change in global score of Brief Assessment of Cognition (BACS) App

    Time frame: baseline, 6 months, 12 months

    Ipad delivered version of BACS assessing memory, attention, executive function and psychomotor speed. Standard scores are generated and summed to create a global cognition score with higher scores indicating better levels of cognitive function.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Vanguard Research Group

Registry information

Acronym: CAT-EM

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2019
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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