Clinical trial NCT01915017: Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia
Official title: Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Cognitive Adaptation Training
Cognitive Behavior Therapy for Psychosis
Schizophrenia
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Brief Psychiatric Rating Scale Psychosis Factor Score
timeFrame: baseline to 9 months
measure: Change in Multnomah Community Ability Scale
timeFrame: Baseline to 9 months
Secondary outcomes:
measure: Change in Auditory Hallucination Rating Scale
timeFrame: Baseline to 9 months
measure: Change in Delusion Rating Scale
timeFrame: Baseline to 9 months
Other outcomes:
measure: Change in Scale to Assess Unawareness of Mental Disorders
timeFrame: Baseline to 9 months
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