SchizophreniaMcogNCT01915017
Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia
A study testing Cognitive Behavior Therapy for Psychosis, Cognitive Adaptation Training and Multi-modal Cognitive Therapy in people with Schizophrenia and Schizoaffective Disorder, run by The University of Texas Health Science Center at San Antonio.
Trial summary
Many individuals with schizophrenia continue to hear voices, have false beliefs, and problems with attention, memory planning and everyday functioning even with medication treatment. The process of recovery in schizophrenia involves treating the whole person. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Cognitive Behavior Therapy for Psychosis, Cognitive Adaptation Training and Multi-modal Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jul 2013
- 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
- Males and females who have given informed consent.
- Between the ages of 18 and 60.
- Diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria as determined on the basis of the Structured Clinical Interview for Diagnosis Checklist (SCID-P) Checklist.
- Receiving treatment with an oral atypical antipsychotic medication other than clozapine
- Able to provide evidence of a stable living environment (individual apartment, family home, board and care facility) with no plans to move in the next year.
- Intact visual and auditory ability as determined by a computerized screening battery.
Show all 9Show fewer
- Ability to read at the 5th grade level or higher based upon WRAT score.
- Able to understand and complete rating scales and neuropsychological testing.
- Delusions or hallucinations at a level of Moderate according to the BPRS. (Score of 4 or higher on items assessing hallucinations, unusual thought content, or suspiciousness.
Who cannot join
- History of significant head trauma, seizure disorder, or mental retardation.
- SOFAS scores >70 indicating a high level of social and occupational functioning.
- Alcohol or drug abuse or dependence within the past 3 months.
- Currently being treated by an ACT team.
- History of violence in the past one year period.
- Exposure to CAT treatment in that past 2 years.
About this study
Many individuals with schizophrenia continue to hear voices, have false beliefs, and problems with attention, memory planning and everyday functioning even with medication treatment. The process of recovery in schizophrenia involves treating the whole person. This study will test a new Multimodal Cognitive Treatment (Mcog). Mcog works around problems in attention, memory and planning by using supports in the home such as signs, checklists, and alarms to improve everyday functioning. Mcog also helps the individual to examine the evidence for their beliefs and to deal with symptoms like voices that are not completely resolved with medications. We will compare 4 treatments to determine if this combined approach improves both symptoms and functioning for individuals with schizophrenia.
Read the detailed description
The process of recovery in schizophrenia involves resolving persistent symptoms and improving functional outcomes. Our research groups have demonstrated that using environmental supports in the patient's home to bypass deficits in cognitive functioning in a treatment called Cognitive Adaptation Training (CAT) improves adherence to medications and functional outcomes in schizophrenia and that Cognitive Behavior Therapy (CBT) decreases symptomatology and the negative effect of persisting symptoms upon individuals with this disorder. Data suggest these treatments have modality specific effects. Targeting both functional outcomes and persistent positive symptoms in a multimodal cognitive treatment provided in the patient's home is likely to have the most robust effects on functional outcomes, persistent symptoms and the distress caused by these symptoms for individuals with schizophrenia. We propose to randomize 200 individuals with schizophrenia taking antipsychotic medications to one of four psychosocial treatments for a period of 9 months: 1) CAT, 2) CBT, 3) Multimodal Cognitive Treatment (Mcog; an integrated treatment featuring aspects of both CAT and CBT), and 4) standard treatment as usual (TAU). Patients will be followed for 6 months after treatment is completed. Outcomes will be assessed at baseline and every 3 months. Primary outcome variables with include measures of symptomatology and functional outcome. We hypothesize that patients in treatments with CBT as a component (CBT and Mcog) will improve to a greater extent on measures of symptomatology than those randomized to non-CBT treatments (CAT or TAU)and that patients in Mcog will improve to a greater extent than those in single modality CAT. Moreover, we hypothesize that patients in treatments with CAT as a component (CAT and Mcog) will improve to a greater extent on measures of symptomatology than those randomized to non-CAT treatments (CBT or TAU) and that patients in Mcog will improve to a greater extent than those in single modality CAT. The potential public health implications of promoting recovery in schizophrenia through multi-modal treatments are profound. By integrating effective treatments the potential for synergistic improvement scan be assessed. Home visits can be costly. Maximizing the benefits to patients by providing multi-modal treatment on the same home visit is likely to improve a broader range of outcomes with minimal additional cost.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Cognitive Behavior Therapy for Psychosis, Cognitive Adaptation Training, Multi-modal Cognitive Therapy, Treatment as Usual
- Keywords
- Cognitive Adaptation Training, Cognitive Behavior Therapy for Psychosis, Schizophrenia
- 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 Behavior Therapy for PsychosisBehavioural
The CBT manual to be used for the present study was based upon the work of Kingdon and Turkington (2005) and Granholm et al., (2005) a group-delivered CBT skills training). Available manuals were modified to improve ease of training and to better accommodate the delivery of the full CBT treatment in the home environment. Supervision will be provided throughout the study by D. Turkington and S. Tai world renowned experts in CBT for psychosis. Training will be held for 1-2 weeks annually and supervision will proceed weekly via SKYPE. All therapists will be certified prior to providing treatment for the trial. Sessions are conducted weekly by master's and doctoral level therapists.
Cognitive Adaptation TrainingBehavioural
CAT supports are established and maintained on weekly home visits by bachelor's and master's level staff. Regular supervision will be provided by the PI who developed CAT.
Multi-modal Cognitive TherapyBehavioural
A manual driven intervention combining CBT and CAT. Weekly sessions delivered in the home focus on altering cognitive biases using CBT and bypassing cognitive deficits using environmental supports
Treatment as UsualOther
Standard medication follow up and limited case management
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy for Psychosis | Experimental | Cognitive behavior therapy for psychosis is a manual-driven collaborative talk-therapy designed to help the individual identify appraisal biases and cognitive distortion, identify alternative explanations for events, and find ways to cope with the distress caused by persistent psychotic symptoms. Receives: Behavioral: Cognitive Behavior Therapy for Psychosis |
| Cognitive Adaptation Training | Experimental | CAT is a manual driven treatment using environmental supports such as signs, alarms, checklists, electronic devices, and the organization of belongings to bypass cognitive and motivational impairments and to cue and sequence adaptive behavior. Receives: Behavioral: Cognitive Adaptation Training |
| Multi-modal Cognitive Therapy | Experimental | Combines Cognitive Behavior Therapy for Psychosis and Cognitive Adaptation Training into one home-delivered intervention Receives: Behavioral: Multi-modal Cognitive Therapy |
| Treatment as Usual | Active comparator | Medication follow up and limited case management provided by the local community mental health center Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Psychiatric Rating Scale Psychosis Factor Score
Combines scores on BPRS for hallucinations, unusual thought content, suspiciousness and conceptual disorganization. Mean score varies from 1-7 with higher scores indicating more severe symptomatology
Measured: baseline to 9 months
Change in Multnomah Community Ability Scale
17-item scale assessing a variety of domains of community adjustment including Interference with functioning, Adjustment to living, Social competence, and Behavioral Problems. Higher scores reflect better community functioning.
Measured: Baseline to 9 months
Secondary outcomes (2)
Change in Auditory Hallucination Rating Scale
Examines the degree to which hallucinatory experiences are negative, distressing and disrupt the activities of the individual. The scale above separates how frequently the voices are distressing vs. non-distressing, the intensity of distress when the voices are distressing, the loudness of the voices and the degree of disruption in daily activities in separate items.
Measured: Baseline to 9 months
Change in Delusion Rating Scale
Delusional ideas are rated with respect to the degree of conviction, the amount and duration of preoccupation, the amount and the level of distress experienced and the level of interference with activities.
Measured: Baseline to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startApr 2008
- Primary completionJul 2013
- Study completionJul 2013
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.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn Velligan, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915017
- Sponsor's protocol ID
- R01MH082793-03
- Acronym
- Mcog
- Status last verified
- Jul 2013
- First submitted
- 26 Jul 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia
- ClinicalTrials.gov ID
- NCT01915017
- Acronym / sponsor ID
- Mcog / R01MH082793-03
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Cognitive Adaptation Training, Cognitive Behavior Therapy for Psychosis, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Aug 2013 (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.
Many individuals with schizophrenia continue to hear voices, have false beliefs, and problems with attention, memory planning and everyday functioning even with medication treatment. The process of recovery in schizophrenia involves treating the whole person. This study will test a new Multimodal Cognitive Treatment (Mcog). Mcog works around problems in attention, memory and planning by using supports in the home such as signs, checklists, and alarms to improve everyday functioning. Mcog also helps the individual to examine the evidence for their beliefs and to deal with symptoms like voices that are not completely resolved with medications. We will compare 4 treatments to determine if this combined approach improves both symptoms and functioning for individuals with schizophrenia.
Detailed description
The process of recovery in schizophrenia involves resolving persistent symptoms and improving functional outcomes. Our research groups have demonstrated that using environmental supports in the patient's home to bypass deficits in cognitive functioning in a treatment called Cognitive Adaptation Training (CAT) improves adherence to medications and functional outcomes in schizophrenia and that Cognitive Behavior Therapy (CBT) decreases symptomatology and the negative effect of persisting symptoms upon individuals with this disorder. Data suggest these treatments have modality specific effects. Targeting both functional outcomes and persistent positive symptoms in a multimodal cognitive treatment provided in the patient's home is likely to have the most robust effects on functional outcomes, persistent symptoms and the distress caused by these symptoms for individuals with schizophrenia. We propose to randomize 200 individuals with schizophrenia taking antipsychotic medications to one of four psychosocial treatments for a period of 9 months: 1) CAT, 2) CBT, 3) Multimodal Cognitive Treatment (Mcog; an integrated treatment featuring aspects of both CAT and CBT), and 4) standard treatment as usual (TAU). Patients will be followed for 6 months after treatment is completed. Outcomes will be assessed at baseline and every 3 months. Primary outcome variables with include measures of symptomatology and functional outcome. We hypothesize that patients in treatments with CBT as a component (CBT and Mcog) will improve to a greater extent on measures of symptomatology than those randomized to non-CBT treatments (CAT or TAU)and that patients in Mcog will improve to a greater extent than those in single modality CAT. Moreover, we hypothesize that patients in treatments with CAT as a component (CAT and Mcog) will improve to a greater extent on measures of symptomatology than those randomized to non-CAT treatments (CBT or TAU) and that patients in Mcog will improve to a greater extent than those in single modality CAT. The potential public health implications of promoting recovery in schizophrenia through multi-modal treatments are profound. By integrating effective treatments the potential for synergistic improvement scan be assessed. Home visits can be costly. Maximizing the benefits to patients by providing multi-modal treatment on the same home visit is likely to improve a broader range of outcomes with minimal additional cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy for Psychosis | Experimental | Behavioral: Cognitive Behavior Therapy for PsychosisCognitive behavior therapy for psychosis is a manual-driven collaborative talk-therapy designed to help the individual identify appraisal biases and cognitive distortion, identify alternative explanations for events, and find ways to cope with the distress caused by persistent psychotic symptoms. |
| Cognitive Adaptation Training | Experimental | Behavioral: Cognitive Adaptation TrainingCAT is a manual driven treatment using environmental supports such as signs, alarms, checklists, electronic devices, and the organization of belongings to bypass cognitive and motivational impairments and to cue and sequence adaptive behavior. |
| Multi-modal Cognitive Therapy | Experimental | Behavioral: Multi-modal Cognitive TherapyCombines Cognitive Behavior Therapy for Psychosis and Cognitive Adaptation Training into one home-delivered intervention |
| Treatment as Usual | Active comparator | Other: Treatment as UsualMedication follow up and limited case management provided by the local community mental health center |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Males and females who have given informed consent.
- Between the ages of 18 and 60.
- Diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria as determined on the basis of the Structured Clinical Interview for Diagnosis Checklist (SCID-P) Checklist.
- Receiving treatment with an oral atypical antipsychotic medication other than clozapine
- Able to provide evidence of a stable living environment (individual apartment, family home, board and care facility) with no plans to move in the next year.
Key exclusion criteria (6 listed)
- History of significant head trauma, seizure disorder, or mental retardation.
- SOFAS scores >70 indicating a high level of social and occupational functioning.
- Alcohol or drug abuse or dependence within the past 3 months.
- Currently being treated by an ACT team.
- History of violence in the past one year period.
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 Behavior Therapy for PsychosisThe CBT manual to be used for the present study was based upon the work of Kingdon and Turkington (2005) and Granholm et al., (2005) a group-delivered CBT skills training). Available manuals were modified to improve ease of training and to better accommodate the delivery of the full CBT treatment in the home environment. Supervision will be provided throughout the study by D. Turkington and S. Tai world renowned experts in CBT for psychosis. Training will be held for 1-2 weeks annually and supervision will proceed weekly via SKYPE. All therapists will be certified prior to providing treatment for the trial. Sessions are conducted weekly by master's and doctoral level therapists. | Behavioural | Cognitive Behavior Therapy for Psychosis |
| Cognitive Adaptation TrainingCAT supports are established and maintained on weekly home visits by bachelor's and master's level staff. Regular supervision will be provided by the PI who developed CAT. | Behavioural | Cognitive Adaptation Training |
| Multi-modal Cognitive TherapyA manual driven intervention combining CBT and CAT. Weekly sessions delivered in the home focus on altering cognitive biases using CBT and bypassing cognitive deficits using environmental supports | Behavioural | Multi-modal Cognitive Therapy |
| Treatment as UsualStandard medication follow up and limited case management | Other | Treatment as Usual |
Primary outcome
Change in Brief Psychiatric Rating Scale Psychosis Factor Score
Time frame: baseline to 9 months
Combines scores on BPRS for hallucinations, unusual thought content, suspiciousness and conceptual disorganization. Mean score varies from 1-7 with higher scores indicating more severe symptomatology
Change in Multnomah Community Ability Scale
Time frame: Baseline to 9 months
17-item scale assessing a variety of domains of community adjustment including Interference with functioning, Adjustment to living, Social competence, and Behavioral Problems. Higher scores reflect better community functioning.
2 secondary outcomes
Change in Auditory Hallucination Rating Scale
Time frame: Baseline to 9 months
Change in Delusion Rating Scale
Time frame: Baseline to 9 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 2 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy for Psychosis, Cognitive Adaptation Training and Multi-modal Cognitive Therapy in people with Schizophrenia and Schizoaffective Disorder, run by The University of Texas Health Science Center at San Antonio.
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 9 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 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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 Brief Psychiatric Rating Scale Psychosis Factor Score (time frame: baseline to 9 months). The study lists 2 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 2 Aug 2013.