SchizophreniaCAT-EMNCT03829280
Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)
A study testing Cognitive Adaptation Training and Community Treatment in people with Schizophrenia and Schizoaffective Disorder, run by The University of Texas Health Science Center at San Antonio at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Cognitive Adaptation Training and Community Treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 Apr 2019to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
United Services Inc.
Dayville, Connecticut, 06241
Peace Health
Eugene, Oregon, 97401
Chestnut Health Systems
Granite City, Illinois, 62040
The Harris Center for Mental Health & IDD
Houston, Texas, 77074
Henderson Behavioral Health
Lauderdale Lakes, Florida, 33319
Community Mental Health Center Inc.
Lawrenceburg, Indiana, 47025
Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03101
Providence Center
Providence, Rhode Island, 02904
About this study
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.
Read the 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
- Being tested
- Cognitive Adaptation Training, Community Treatment
- Keywords
- Schizophrenia, Cognitive Adaptation Training, Functional Outcome
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Adaptation TrainingBehavioural
Also called CAT
Psychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior
Community TreatmentBehavioural
Also called CT
Medication follow-up and case management as provided in usual community care in the setting
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Adaptation Training | Experimental | 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. Receives: Behavioral: Cognitive Adaptation Training |
| Community Treatment | Active comparator | Medication follow-up and case management as provided by the community mental health center according to usual care. Receives: Behavioral: Community Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social and Occupational Functioning Scale Scores
A rating from 0-100 reflecting global level of Social and Occupational functioning; Higher scores indicate better functioning.
Measured: baseline, 6 months, 12 months
Secondary outcomes (5)
Change in Daily activity
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)
Measured: baseline, 6 months, 12 months
Change in Multnomah Community Ability Scale mean score
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.
Measured: baseline, 6 months, 12 months
Change in Adherence Estimate Score
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.
Measured: baseline, 6 months, 12 months
Change in Negative Symptom Assessment-16 Mean Score
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.
Measured: baseline, 6 months, 12 months
Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score
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.
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start4 Apr 2019
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized clinical trial conducted at 8 community mental health outpatient treatment sites across the country
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Vanguard Research Group, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dawn Velligan, The University of Texas Health Science Center at San Antonio
- Investigators
- Dawn Velligan, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829280
- Sponsor's protocol ID
- HSC20180237H
- Other IDs
- 1R01MH117101-01
- Acronym
- CAT-EM
- Status last verified
- Jul 2023
- First submitted
- 28 Jan 2019
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will be fully compliant with the NIMH Data Archive Data Sharing Terms and Conditions, including submitting and harmonizing all descriptive/raw data and analyzed data generated by the grant at the item and subject-level to the National Database for Clinical Trials (NDCT). All submitted data will include a Global Unique Identifier (GUID) and will not include personally identifiable information (PII).
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)
- ClinicalTrials.gov ID
- NCT03829280
- Acronym / sponsor ID
- CAT-EM / HSC20180237H
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Cognitive Adaptation Training, Functional Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Vanguard Research Group, National Institute of Mental Health (NIMH)
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized clinical trial conducted at 8 community mental health outpatient treatment sites across the country
| Arm | Type | Receives |
|---|---|---|
| Cognitive Adaptation Training | Experimental | Behavioral: Cognitive Adaptation TrainingPsychosocial 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. |
| Community Treatment | Active comparator | Behavioral: Community TreatmentMedication follow-up and case management as provided by the community mental health center according to usual care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Adaptation TrainingAlso: CATPsychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior | Behavioural | Cognitive Adaptation Training |
| Community TreatmentAlso: CTMedication follow-up and case management as provided in usual community care in the setting | Behavioural | Community Treatment |
Primary outcome
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.
5 secondary outcomes
Change in Daily activity
Time frame: baseline, 6 months, 12 months
Change in Multnomah Community Ability Scale mean score
Time frame: baseline, 6 months, 12 months
Change in Adherence Estimate Score
Time frame: baseline, 6 months, 12 months
Change in Negative Symptom Assessment-16 Mean Score
Time frame: baseline, 6 months, 12 months
Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score
Time frame: baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes. The investigators will be fully compliant with the NIMH Data Archive Data Sharing Terms and Conditions, including submitting and harmonizing all descriptive/raw data and analyzed data generated by the grant at the item and subject-level to the National Database for Clinical Trials (NDCT). All submitted data will include a Global Unique Identifier (GUID) and will not include personally identifiable information (PII).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Velligan, PhD principal investigator
University of Texas
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Adaptation Training and Community Treatment in people with Schizophrenia and Schizoaffective Disorder, run by The University of Texas Health Science Center at San Antonio at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social and Occupational Functioning Scale Scores (time frame: baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.