Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia

Study Overview
=================
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.

Official Title
-----------------
Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavior Therapy for Psychosis
* Behavioral: Cognitive Adaptation Training
* Behavioral: Multi-modal Cognitive Therapy
* Other: Treatment as Usual


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavior Therapy for Psychosis<br>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. | Behavioral: Cognitive Behavior Therapy for Psychosis<br>* 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.<br>|
| Experimental: Cognitive Adaptation Training<br>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. | Behavioral: Cognitive Adaptation Training<br>* 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.<br>|
| Experimental: Multi-modal Cognitive Therapy<br>Combines Cognitive Behavior Therapy for Psychosis and Cognitive Adaptation Training into one home-delivered intervention | Behavioral: Multi-modal Cognitive Therapy<br>* 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<br>|
| Active Comparator: Treatment as Usual<br>Medication follow up and limited case management provided by the local community mental health center | Other: Treatment as Usual<br>* Standard medication follow up and limited case management<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline to 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Adaptation Training, Cognitive Behavior Therapy for Psychosis, Schizophrenia