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Brain Imaging, Cognitive Enhancement and Early Schizophrenia (BICEPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborators:
University of Pittsburgh
Massachusetts General Hospital
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01561859
First received: March 21, 2012
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

The proposed project is designed to examine the effects of cognitive rehabilitation on brain structure and function in a randomized trial of 102 early course schizophrenia patients treated for 18 months with either cognitive enhancement therapy (CET) or an Enriched Supportive Therapy (EST) control, and then followed-up at 1-year post-treatment.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Behavioral: Cognitive Enhancement Therapy
Behavioral: Enriched Supportive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Brain Imaging, Cognitive Enhancement and Early Schizophrenia

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Confirm the neuroprotective effects of CET on frontal and temporal brain structure [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Aim #1: Confirm the neuroprotective effects of CET on frontal and temporal brain structure. Structural magnetic resonance imaging (MRI) assessments will be collected along with cognitive and functional outcome data at baseline, 9, and 18 months. It is hypothesized that patients treated with CET will demonstrate decreased loss of frontal and temporal gray matter relative to EST, and that this neuroprotection will be a mechanism of cognitive and functional improvement.

  • Examine the effects of CET on fronto-temporal brain function. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    Aim #2: Examine the effects of CET on fronto-temporal brain function. Functional MRI data using established executive and social cognition paradigms will be collected at baseline, 9, and 18 months along with cognitive and functional outcome data. It is hypothesized that CET patients will demonstrate enhanced fronto-temporal brain activity during these tasks relative to EST (see Section 3C.6.2 for specific predictions), and that this enhanced brain activity will be a mechanism of cognitive and functional improvement.

  • Examine the durability of CET effects on fronto-temporal brain structure and function, cognition, and functional outcome at 1 year post-treatment [ Time Frame: 1 year post-treatment ] [ Designated as safety issue: No ]
    Aim #3: Examine the durability of CET effects on fronto-temporal brain structure and function, cognition, and functional outcome at 1 year post-treatment. Identical neuroimaging, cognitive, and behavioral data will be collected as those assessed during active treatment. It is hypothesized that the differential neurobiologic benefits of CET relative to EST observed in Aims 1 and 2, and the cognitive and functional benefits of CET observed during active treatment will be sustained 1 year post-treatment.


Secondary Outcome Measures:
  • Explore the effects of a fronto-temporal structural and functional reserve on CET treatment response. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    Exploratory Aim: Explore the effects of a fronto-temporal structural and functional reserve on CET treatment response. Moderator analyses will examine whether pre-treatment fronto-temporal structural and functional brain reserves (operationalized in Section 3C.8.2) predict larger cognitive and functional gains in CET. Exploratory analyses will also examine the degree to which later (18 mo) treatment improvement is dependent upon early (9 mo) neuroprotection and increased brain function, which may reflect plasticity.


Estimated Enrollment: 102
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive enhancement therapy
Cognitive Enhancement Therapy (CET) consists of approximately 60 hours of computer-assisted neurocognitive training in attention, memory, and problem-solving; and 45 social-cognitive group sessions that employ in vivo learning experiences to foster the development of social wisdom and success in interpersonal interactions. CET begins with 3 months of weekly 1-hour neurocognitive training in attention, after which patients begin the weekly 1.5-hour social-cognitive groups. Neurocognitive training then proceeds concurrently with the socialcognitive groups
Behavioral: Cognitive Enhancement Therapy
Cognitive Enhancement Therapy (CET) consists of approximately 60 hours of computer-assisted neurocognitive training in attention, memory, and problem-solving; and 45 social-cognitive group sessions that employ in vivo learning experiences to foster the development of social wisdom and success in interpersonal interactions. CET begins with 3 months of weekly 1-hour neurocognitive training in attention, after which patients begin the weekly 1.5-hour social-cognitive groups. Neurocognitive training then proceeds concurrently with the socialcognitive groups.
Active Comparator: Enriched Supportive Therapy
Enriched Supportive Therapy is an individual approach that includes the established principles of supportive therapy previously tested by our group, which are "enriched" by selected practice principles from the effective Personal Therapy. These manualized supportive therapeutic practices include active listening, correct empathy, appropriate reassurance, basic psychoeducation, including computer-based educational programs, reinforcement of health-promoting initiatives, the provision of case management, and reliance on the advocacy and advice of the therapist in times of crisis.
Behavioral: Enriched Supportive Therapy
Enriched Supportive Therapy is an individual approach that includes the established principles of supportive therapy previously tested by our group, which are "enriched" by selected practice principles from the effective Personal Therapy. These manualized supportive therapeutic practices include active listening, correct empathy, appropriate reassurance, basic psychoeducation, including computer-based educational programs, reinforcement of health-promoting initiatives, the provision of case management, and reliance on the advocacy and advice of the therapist in times of crisis.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will be included if they have:

  1. a diagnosis of schizophrenia or schizoaffective disorder verified by the SCID (in our data patients with both conditions respond similarly to CET);
  2. duration since first psychotic symptom of < 5 years;
  3. stable positive symptoms (Clinical Global Impression score of < 4 for at least 2 months [i.e., 2 consecutive visits]);
  4. are currently maintained on and compliant with prescribed antipsychotic medication;
  5. age 18-35 years;
  6. significant social and cognitive disability based on the Cognitive Style and Social Cognition Eligibility Interview25 utilized in previous CET studies;
  7. current IQ > 80; and
  8. the ability to read (sixth grade level or higher) and speak fluent English. This is a study of early course schizophrenia, not first-episode schizophrenia. A duration of illness since first psychotic symptom of < 5 years is adequate to define the early phase of the illness, particularly given that the average duration of untreated psychosis is a year or more.76 Eligibility criteria regarding IQ are justified from previous experience with CET indicating that individuals with severe mental incapacity are better served with less cognitively advanced programs.

Exclusion Criteria:

In order to avoid confounders likely to affect cognition and limit response to cognitive rehabilitation, we will exclude those with:

  1. significant neurological or medical disorders that may produce cognitive impairment (e.g., seizure disorder, traumatic brain injury);
  2. persistent suicidal or homicidal behavior;
  3. a recent (within the past 3 months) history of substance abuse or dependence; and
  4. any MRI contraindications such as ferromagnetic objects in the body.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561859

Contacts
Contact: Matcheri Keshavan, MD 617-754-1256 mkeshava@bidmc.harvard.edu
Contact: Joanne Wojcik, PhD 617-754-1230 jwojcik@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Matcheri Keshavan, MD         
Massachusetts Institute of Technology Not yet recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Susan Whifield-Gabrieli, PhD    617-324-2893    swg@mitt.edu   
Sub-Investigator: Susan Whitfield-Gabrieli, PhD         
Massachusetts General Hospital Not yet recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Larry Seidman, PhD    617-754-1238    lseidman@bidmc.harvard.edu   
Sub-Investigator: Larry Seidman, PhD         
United States, Pennsylvania
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Shaun Eack, PhD    412-648-9029    sme12@pitt.edu   
Sub-Investigator: Shaun Eack, PhD         
Western Psychiatry Institute and Clinic Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Konsale Prasad, MD    412-586-9014    prasadkm@umpc.edu   
Contact: Mary Phillips, MD    412-383-8206    phillipsm1@upmc.edu   
Sub-Investigator: Konsale Prasad, MD         
Sub-Investigator: Mary Phillips, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
University of Pittsburgh
Massachusetts General Hospital
Investigators
Principal Investigator: Matcheri Keshavan, MD Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01561859     History of Changes
Other Study ID Numbers: 2011-P-000267/1
Study First Received: March 21, 2012
Last Updated: March 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Early Course Schizophrenia
Cognitive Enhancement Therapy
Enriched Supportive Therapy

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 24, 2014