Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia (Mcog)
1 de agosto de 2013 atualizado por: Dawn Velligan, The University of Texas Health Science Center at San Antonio
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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
178
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 60 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Cognitive Behavior Therapy for Psychosis
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.
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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.
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Experimental: Cognitive Adaptation Training
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.
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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.
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Experimental: Multi-modal Cognitive Therapy
Combines Cognitive Behavior Therapy for Psychosis and Cognitive Adaptation Training into one home-delivered intervention
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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
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Comparador Ativo: Treatment as Usual
Medication follow up and limited case management provided by the local community mental health center
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Standard medication follow up and limited case management
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Brief Psychiatric Rating Scale Psychosis Factor Score
Prazo: 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
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baseline to 9 months
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Change in Multnomah Community Ability Scale
Prazo: 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.
|
Baseline to 9 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Auditory Hallucination Rating Scale
Prazo: Baseline to 9 months
|
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.
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Baseline to 9 months
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Change in Delusion Rating Scale
Prazo: Baseline to 9 months
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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.
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Baseline to 9 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Scale to Assess Unawareness of Mental Disorders
Prazo: Baseline to 9 months
|
Assesses insight into the illness, specific symptoms and the need for treatment.
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Baseline to 9 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de abril de 2008
Conclusão Primária (Real)
1 de julho de 2013
Conclusão do estudo (Real)
1 de julho de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
26 de julho de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de agosto de 2013
Primeira postagem (Estimativa)
2 de agosto de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
2 de agosto de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de agosto de 2013
Última verificação
1 de julho de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R01MH082793-03 (Concessão/Contrato do NIH dos EUA)
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