Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia

NCT01915017 | Completed DMC

• 1 other identifier: R01MH082793-03
• Study Type: interventional
• Target: 178
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Cognitive Adaptation Training; Cognitive Behavior Therapy for Psychosis; Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Auditory Hallucination Rating Scale

  Baseline to 9 months

• Change in Delusion Rating Scale

  Baseline to 9 months

Other Outcomes (1)

• Change in Scale to Assess Unawareness of Mental Disorders

  Baseline to 9 months

Study Arms (4)

Cognitive Behavior Therapy for Psychosis

EXPERIMENTAL

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

Cognitive Adaptation Training

EXPERIMENTAL

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

Multi-modal Cognitive Therapy

EXPERIMENTAL

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

Behavioral: Multi-modal Cognitive Therapy

Treatment as Usual

ACTIVE COMPARATOR

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

Other: Treatment as Usual

Interventions

Cognitive Behavior Therapy for Psychosis BEHAVIORAL

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.

Cognitive Behavior Therapy for Psychosis

Cognitive Adaptation Training BEHAVIORAL

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.

Cognitive Adaptation Training

Multi-modal Cognitive Therapy BEHAVIORAL

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

Multi-modal Cognitive Therapy

Treatment as Usual OTHER

Standard medication follow up and limited case management

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Cognitive Behavioral Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director Division of Schizophrenia and Related Disorders

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: August 2, 2013
• Study Start: April 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 2, 2013

Record last verified: 2013-07