Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

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. 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.
    

Intervention name(s): Cognitive Behavior Therapy for Psychosis; Cognitive Adaptation Training; Multi-modal Cognitive Therapy; Treatment as Usual
Intervention type(s): Behavioral; Behavioral; Behavioral; Other
Intervention description(s): 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.; 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.; 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; Standard medication follow up and limited case management
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Adaptation Training; Cognitive Behavior Therapy for Psychosis; Schizophrenia