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Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia (Mcog)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Behavior Therapy for Psychosis
Cognitive Adaptation Training
Multi-modal Cognitive Therapy
Treatment as Usual
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Cognitive Adaptation Training, Cognitive Behavior Therapy for Psychosis, Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females who have given informed consent.
  2. Between the ages of 18 and 60.
  3. 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.
  4. Receiving treatment with an oral atypical antipsychotic medication other than clozapine
  5. 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.
  6. Intact visual and auditory ability as determined by a computerized screening battery.
  7. Ability to read at the 5th grade level or higher based upon WRAT score.
  8. Able to understand and complete rating scales and neuropsychological testing.
  9. 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:

  1. History of significant head trauma, seizure disorder, or mental retardation.
  2. SOFAS scores >70 indicating a high level of social and occupational functioning.
  3. Alcohol or drug abuse or dependence within the past 3 months.
  4. Currently being treated by an ACT team.
  5. History of violence in the past one year period.
  6. Exposure to CAT treatment in that past 2 years.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Cognitive Behavior Therapy for Psychosis

    Cognitive Adaptation Training

    Multi-modal Cognitive Therapy

    Treatment as Usual

    Arm Description

    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.

    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.

    Combines Cognitive Behavior Therapy for Psychosis and Cognitive Adaptation Training into one home-delivered intervention

    Medication follow up and limited case management provided by the local community mental health center

    Outcomes

    Primary Outcome Measures

    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
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    July 26, 2013
    Last Updated
    August 1, 2013
    Sponsor
    The University of Texas Health Science Center at San Antonio
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01915017
    Brief Title
    Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia
    Acronym
    Mcog
    Official Title
    Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Texas Health Science Center at San Antonio

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Schizoaffective Disorder
    Keywords
    Cognitive Adaptation Training, Cognitive Behavior Therapy for Psychosis, Schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    178 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive Behavior Therapy for Psychosis
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Cognitive Adaptation Training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Multi-modal Cognitive Therapy
    Arm Type
    Experimental
    Arm Description
    Combines Cognitive Behavior Therapy for Psychosis and Cognitive Adaptation Training into one home-delivered intervention
    Arm Title
    Treatment as Usual
    Arm Type
    Active Comparator
    Arm Description
    Medication follow up and limited case management provided by the local community mental health center
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavior Therapy for Psychosis
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Adaptation Training
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Multi-modal Cognitive Therapy
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Treatment as Usual
    Intervention Description
    Standard medication follow up and limited case management
    Primary Outcome Measure Information:
    Title
    Change in Brief Psychiatric Rating Scale Psychosis Factor Score
    Description
    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
    Time Frame
    baseline to 9 months
    Title
    Change in Multnomah Community Ability Scale
    Description
    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.
    Time Frame
    Baseline to 9 months
    Secondary Outcome Measure Information:
    Title
    Change in Auditory Hallucination Rating Scale
    Description
    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.
    Time Frame
    Baseline to 9 months
    Title
    Change in Delusion Rating Scale
    Description
    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.
    Time Frame
    Baseline to 9 months
    Other Pre-specified Outcome Measures:
    Title
    Change in Scale to Assess Unawareness of Mental Disorders
    Description
    Assesses insight into the illness, specific symptoms and the need for treatment.
    Time Frame
    Baseline to 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia

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