SchizophreniaNCT00455663
Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia
A study testing Cognitive Adaptation Training, Pharm-Cognitive Adaptation Training and Treatment as usual 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 the effectiveness of three treatments in improving medication adherence, symptoms, and function in people 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 Training, Pharm-Cognitive Adaptation Training and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2000to Jan 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of schizophrenia or schizoaffective disorder
- If entering the study as an inpatient, hospitalization was recent
- Currently receiving treatment with an atypical antipsychotic and continuation on the medication has been recommended
- Assumes primary responsibility for taking medication
- Currently living in a stable environment
Who cannot join
- History of significant head trauma, seizure disorder, or mental retardation
- History of alcohol or drug abuse or dependence within 1 month prior to study entry
- History of violence within 6 months prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
San Antonio, Texas, 78229-3900
About this study
Official title: Medication Adherence and Outcomes in Schizophrenia
This study will compare the effectiveness of three treatments in improving medication adherence, symptoms, and function in people with schizophrenia.
Read the detailed description
Schizophrenia is a chronic and severely disabling mental disorder. People with schizophrenia may experience hallucinations, delusions, disordered thinking, movement disorders, social withdrawal, and cognitive deficits. Antipsychotic medications have been effective in alleviating many of the symptoms of schizophrenia and improving the lives of people with the disease. It is well established, however, that poor adherence to antipsychotic medications can lead to relapse and rehospitalization. Cognitive deficits often contribute to treatment nonadherence by compromising patients' capacity to establish routines for taking medication. Cognitive adaptation training (CAT) is a treatment approach designed to alter the physical environment of individuals with schizophrenia to compensate for cognitive deficits and improve adaptive function. For example, various environmental supports, such as signs, checklists, and electronic devices, are used to remind patients to take their medication. Studies have shown that CAT's support system led to better treatment outcomes than those produced by standard care in people with schizophrenia. This study will compare the effectiveness of two CAT treatments versus standard treatment in improving medication adherence, symptoms, and function in people with schizophrenia.
After providing a blood sample, participants in this single-blind study will be randomly assigned to Full-CAT, Pharm-CAT, or treatment as usual for 9 months. Participants receiving treatment as usual will not receive CAT support. Full-CAT will entail a comprehensive use of environmental supports to improve multiple areas of adaptive functioning. Pharm-CAT will provide support for medication adherence only. Participants assigned to one of the two CAT groups will receive weekly treatments in their homes. All participants will report to the study site once every 3 months to assess medication adherence, symptomatology, and adaptive functioning. Participants will be interviewed by the study physician for 2 to 3 hours at each visit. A member of the study staff will also visit each participant's home at a random, unannounced time once every 3 months to obtain a blood sample. Follow-up visits will occur 3 and 6 months following the end of treatment.
- Conditions
- Schizophrenia
- Being tested
- Cognitive Adaptation Training, Pharm-Cognitive Adaptation Training, Treatment as usual
- Keywords
- Schizoaffective Disorder, Medication Adherence
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Adaptation TrainingBehavioural
Environmental supports for all independent living skills
Pharm-Cognitive Adaptation TrainingBehavioural
Environmental supports for medication and appointment adherence
Treatment as usualOther
Medication follow-up and limited case management provided by local community mental health authority
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Adaptation Training | Experimental | In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes. Receives: Behavioral: Cognitive Adaptation Training |
| Pharm-Cognitive Adaptation Training | Experimental | Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up. Receives: Behavioral: Pharm-Cognitive Adaptation Training |
| Treatment As Usual | Active comparator | Medication follow up and limited case management provided by local mental health authority Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence-pill Count
% medication taken as determined by unannounced pill counts conducted in the home on 2 occasions in each 3 month period. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.
Measured: 1 final score combined for endpoint for 9 months of treatment and 6 months follow up
Positive Symptoms
Positive symptoms subscale of the Brief Psychiatric Rating Scale includes delusions, hallucinations, conceptual disorganization and suspiciousness-Mean score averaging these items, variability 1-7. Higher scores reflect higher level of symptoms. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.
Measured: 1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up
Social and Occupational Functioning Scale Score
Scores range from 0 to 100 with higher scores reflecting better functioning. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.
Measured: 1 endpoint ls means combining 9 months of treatment and 6 months follow up
Number of Patients Surviving Without Relapse/Exacerbation
A relapse was scored (only for patients meeting criteria for remission) if scores on any of the 4 items assessing positive symptoms on the Brief Psychiatric Rating Scale increased a minimum of 2 points to a score of 5 or higher, if the patient was suicidal, if the patient was hospitalized, or if the patient was unable to care for themselves without continual supervision
Measured: 9 months of treatment 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startNov 2000
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dawn Velligan, The University of Texas Health Science Center at San Antonio
- Investigators
- Dawn I. Velligan, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455663
- Sponsor's protocol ID
- R01MH062850
- Other IDs
- R01MH062850, DAHBR 96-BHA
- Status last verified
- May 2015
- First submitted
- 2 Apr 2007
- Last updated
- 15 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Adherence and Outcomes in Schizophrenia
- ClinicalTrials.gov ID
- NCT00455663
- Acronym / sponsor ID
- R01MH062850
- Conditions
- Schizophrenia
- Keywords
- Schizoaffective Disorder, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2000
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 4 Apr 2007 (estimated)
- Results
- Posted 15 Jun 2015
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 the effectiveness of three treatments in improving medication adherence, symptoms, and function in people with schizophrenia.
Detailed description
Schizophrenia is a chronic and severely disabling mental disorder. People with schizophrenia may experience hallucinations, delusions, disordered thinking, movement disorders, social withdrawal, and cognitive deficits. Antipsychotic medications have been effective in alleviating many of the symptoms of schizophrenia and improving the lives of people with the disease. It is well established, however, that poor adherence to antipsychotic medications can lead to relapse and rehospitalization. Cognitive deficits often contribute to treatment nonadherence by compromising patients' capacity to establish routines for taking medication. Cognitive adaptation training (CAT) is a treatment approach designed to alter the physical environment of individuals with schizophrenia to compensate for cognitive deficits and improve adaptive function. For example, various environmental supports, such as signs, checklists, and electronic devices, are used to remind patients to take their medication. Studies have shown that CAT's support system led to better treatment outcomes than those produced by standard care in people with schizophrenia. This study will compare the effectiveness of two CAT treatments versus standard treatment in improving medication adherence, symptoms, and function in people with schizophrenia.
After providing a blood sample, participants in this single-blind study will be randomly assigned to Full-CAT, Pharm-CAT, or treatment as usual for 9 months. Participants receiving treatment as usual will not receive CAT support. Full-CAT will entail a comprehensive use of environmental supports to improve multiple areas of adaptive functioning. Pharm-CAT will provide support for medication adherence only. Participants assigned to one of the two CAT groups will receive weekly treatments in their homes. All participants will report to the study site once every 3 months to assess medication adherence, symptomatology, and adaptive functioning. Participants will be interviewed by the study physician for 2 to 3 hours at each visit. A member of the study staff will also visit each participant's home at a random, unannounced time once every 3 months to obtain a blood sample. Follow-up visits will occur 3 and 6 months following the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Adaptation Training | Experimental | Behavioral: Cognitive Adaptation TrainingIn home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes. |
| Pharm-Cognitive Adaptation Training | Experimental | Behavioral: Pharm-Cognitive Adaptation TrainingUses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up. |
| Treatment As Usual | Active comparator | Other: Treatment as usualMedication follow up and limited case management provided by local mental health authority |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of schizophrenia or schizoaffective disorder
- If entering the study as an inpatient, hospitalization was recent
- Currently receiving treatment with an atypical antipsychotic and continuation on the medication has been recommended
- Assumes primary responsibility for taking medication
- Currently living in a stable environment
Key exclusion criteria (3 listed)
- History of significant head trauma, seizure disorder, or mental retardation
- History of alcohol or drug abuse or dependence within 1 month prior to study entry
- History of violence within 6 months prior to study entry
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 TrainingEnvironmental supports for all independent living skills | Behavioural | Cognitive Adaptation Training |
| Pharm-Cognitive Adaptation TrainingEnvironmental supports for medication and appointment adherence | Behavioural | Pharm-Cognitive Adaptation Training |
| Treatment as usualMedication follow-up and limited case management provided by local community mental health authority | Other | Treatment As Usual |
Primary outcome
Medication Adherence-pill Count
Time frame: 1 final score combined for endpoint for 9 months of treatment and 6 months follow up
% medication taken as determined by unannounced pill counts conducted in the home on 2 occasions in each 3 month period. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.
Positive Symptoms
Time frame: 1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up
Positive symptoms subscale of the Brief Psychiatric Rating Scale includes delusions, hallucinations, conceptual disorganization and suspiciousness-Mean score averaging these items, variability 1-7. Higher scores reflect higher level of symptoms. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.
Social and Occupational Functioning Scale Score
Time frame: 1 endpoint ls means combining 9 months of treatment and 6 months follow up
Scores range from 0 to 100 with higher scores reflecting better functioning. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.
Number of Patients Surviving Without Relapse/Exacerbation
Time frame: 9 months of treatment 6 months follow up
A relapse was scored (only for patients meeting criteria for remission) if scores on any of the 4 items assessing positive symptoms on the Brief Psychiatric Rating Scale increased a minimum of 2 points to a score of 5 or higher, if the patient was suicidal, if the patient was hospitalized, or if the patient was unable to care for themselves without continual supervision
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
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, PhD principal investigator
University of Texas
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 Training, Pharm-Cognitive Adaptation Training and Treatment as usual 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 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 15 Jun 2015. 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?
Yes. Results are posted in the registry (first posted 15 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Medication Adherence-pill Count (time frame: 1 final score combined for endpoint for 9 months of treatment and 6 months follow up). The study lists 4 primary outcomes in all. 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 15 Jun 2015.