SchizophreniaNCT00051740
Treating Thought Problems in Patients With Schizophrenia
A study testing Cognitive Adaptation Therapy (CAT) and Minimal Environmental Supports (MES) in people with Schizophrenia, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This study will compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment. This study will also determine whether the intensity of CAT can be reduced and still provide benefits to patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cognitive Adaptation Therapy (CAT) and Minimal Environmental Supports (MES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Oct 2008
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Treatment with an atypical antipsychotic medication
- Stable living environment
- Able to read, understand, and complete rating scales and neuropsychological testing
- Willing to participate in psychosocial treatments for schizophrenia that may involve home visits
Who cannot join
- History of significant head trauma, seizure disorder, or mental retardation
- Alcohol or drug abuse that could interfere with participation in the study
- Treatment by an ACT team
- History of violence in the past year
- Score > 80 on the SOFAS
- Hospitalized in the past year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Compensating for Cognitive Deficits in Schizophrenia
This study will compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment. This study will also determine whether the intensity of CAT can be reduced and still provide benefits to patients with schizophrenia.
Read the detailed description
Many schizophrenia patients have serious difficulties that affect their quality of life. Cognitive Adaptation Training (CAT) may improve adaptive functioning, quality of life, and rates of relapse in schizophrenia patients. CAT, which involves compensatory strategies or environmental supports, is tailored to each individual and is based on executive functioning levels and other factors.
Participants are randomly assigned to CAT, Minimal Environmental Supports (MES), or treatment as usual for 2 years. Participants receiving CAT will have a trained therapist make weekly visits to their home for 9 months. Over the following 3 months, the frequency of CAT visits will be slowly reduced to once a month. For the remaining 12 months of treatment, patients receive CAT only once a month.
Participants assigned to the MES group receive a generic set of supplies and equipment (calendar, alarm clock, watch, bus passes, etc.) at the beginning of the 2-year period. Each month, the supplies are replenished as necessary during the patient's scheduled clinic visit.
In all groups, assessments of adaptive function and quality of life occur at study start and at 3, 6, 9, 18, and 24 months.
- Conditions
- Schizophrenia
- Being tested
- Cognitive Adaptation Therapy (CAT), Minimal Environmental Supports (MES)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Adaptation Therapy (CAT)Behavioural
Minimal Environmental Supports (MES)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Adaptation Therapy | Active comparator | Subjects receive Cognitive adaptation therapy as part of treatment for schizophrenia Receives: Behavioral: Cognitive Adaptation Therapy (CAT) |
| Minimal Environmental Support | Active comparator | Subjects receive minimal environmental support in schizophrenia treatment Receives: Behavioral: Minimal Environmental Supports (MES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary
compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2003 (estimated)
- Study startFeb 2002
- Primary completionOct 2008
- Study completionOct 2008
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn Velligan, The University of Texas Health Science Center at San Antonio
- Investigators
- Dawn I. Velligan, Ph.D., Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051740
- Sponsor's protocol ID
- R01MH061775
- Other IDs
- DATR A4-GPS
- Status last verified
- Apr 2013
- First submitted
- 15 Jan 2003
- Last updated
- 9 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compensating for Cognitive Deficits in Schizophrenia
- ClinicalTrials.gov ID
- NCT00051740
- Acronym / sponsor ID
- R01MH061775
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Feb 2002
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 17 Jan 2003 (estimated)
- 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.
This study will compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment. This study will also determine whether the intensity of CAT can be reduced and still provide benefits to patients with schizophrenia.
Detailed description
Many schizophrenia patients have serious difficulties that affect their quality of life. Cognitive Adaptation Training (CAT) may improve adaptive functioning, quality of life, and rates of relapse in schizophrenia patients. CAT, which involves compensatory strategies or environmental supports, is tailored to each individual and is based on executive functioning levels and other factors.
Participants are randomly assigned to CAT, Minimal Environmental Supports (MES), or treatment as usual for 2 years. Participants receiving CAT will have a trained therapist make weekly visits to their home for 9 months. Over the following 3 months, the frequency of CAT visits will be slowly reduced to once a month. For the remaining 12 months of treatment, patients receive CAT only once a month.
Participants assigned to the MES group receive a generic set of supplies and equipment (calendar, alarm clock, watch, bus passes, etc.) at the beginning of the 2-year period. Each month, the supplies are replenished as necessary during the patient's scheduled clinic visit.
In all groups, assessments of adaptive function and quality of life occur at study start and at 3, 6, 9, 18, and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Adaptation Therapy | Active comparator | Behavioral: Cognitive Adaptation Therapy (CAT)Subjects receive Cognitive adaptation therapy as part of treatment for schizophrenia |
| Minimal Environmental Support | Active comparator | Behavioral: Minimal Environmental Supports (MES)Subjects receive minimal environmental support in schizophrenia treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Treatment with an atypical antipsychotic medication
- Stable living environment
- Able to read, understand, and complete rating scales and neuropsychological testing
- Willing to participate in psychosocial treatments for schizophrenia that may involve home visits
Key exclusion criteria (6 listed)
- History of significant head trauma, seizure disorder, or mental retardation
- Alcohol or drug abuse that could interfere with participation in the study
- Treatment by an ACT team
- History of violence in the past year
- Score > 80 on the SOFAS
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 Therapy (CAT) | Behavioural | Cognitive Adaptation Therapy |
| Minimal Environmental Supports (MES) | Behavioural | Minimal Environmental Support |
Primary outcome
Primary
Time frame: up to 24 months
compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment.
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 Apr 2013.
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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 I. Velligan, Ph.D. principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Adaptation Therapy (CAT) and Minimal Environmental Supports (MES) in people with Schizophrenia, run by The University of Texas Health Science Center at San Antonio at 1 site 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 5 inclusion and 6 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 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Primary (time frame: up to 24 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 Apr 2013.