Treatment to Enhance Cognition in Bipolar Disorder (TREC-BD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Mclean Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kathryn Eve Lewandowski, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01470781
First received: July 11, 2011
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

The purpose of the present study is to evaluate a neuroplasticity-oriented, computer-based cognitive remediation treatment program in patients with bipolar disorder and its effects on cognitive deficits and community functioning compared to an active, computer-based control.


Condition Intervention Phase
Bipolar Disorder
Psychosis
Behavioral: BrainWorks
Behavioral: Computer Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Cognitive Remediation Treatment Program for Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • MATRICS MCCB Battery [ Time Frame: Post-treatment; after 6 months no active intervention ] [ Designated as safety issue: No ]

    The MATRICS battery includes 10 tasks that measure processing speed, attention, working memory, verbal learning, visual learning, problem solving and social cognition. Total administration time is 60-90 minutes.

    The second assessment point will measure change after the initial outcome (that is, change from post-treatment after 6 months of no active intervention).



Secondary Outcome Measures:
  • Young Mania Rating Scale [ Time Frame: Pre-treatment; Post-treatment; after 6 months of no active study intervention ] [ Designated as safety issue: No ]
    Brief questionnaire asking about manic symptoms; duration = approximately 10 minutes

  • Montgomery-Asberg Depression Rating Scale [ Time Frame: pre-treatment; post-treatment; after 6 months of no active study intervention ] [ Designated as safety issue: No ]
    Brief questionnaire administered by study staff regarding level of depressive symptoms; duration = approximately 10 minutes

  • Positive and Negative Syndrome Scale [ Time Frame: pre-treatment; post-treatment; after 6 months of no active study intervention ] [ Designated as safety issue: No ]
    Interview-administered questionnaire asking about positive and negative symptoms of psychosis, and general psychiatric symptoms; duration = approximately 20 minutes

  • Multnomah Community Ability Scale [ Time Frame: pre and post treatment; after 6 months of no active study intervention ] [ Designated as safety issue: No ]
    The MCAS measures functioning in psychiatric patients in multiple domains (e.g. social interest/effectiveness, independence, and meaningful activities). Administered in interview format; duration = approximately 10 minutes

  • Social and Occupational Functioning Assessment Scale [ Time Frame: pre and post treatment; after 6 months of no active study intervention ] [ Designated as safety issue: No ]
    The SOFAS is a 100-point scale similar to the Global Assessment of Functioning designed to evaluate social and occupational functioning not directly influenced by psychological symptom severity.


Estimated Enrollment: 130
Study Start Date: June 2011
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Remediation
This arm will receive computer-based cognitive remediation treatment 3 times per week for 24 weeks, for a total of 70 hours of treatment
Behavioral: BrainWorks
13 programs targeting cognition in 4 separate domains: Auditory processing, visual processing, social cognition, and executive functioning. Games are imbedded in a format that is engaging and interactive. Animated characters serve as "directors" for each program, explaining the tasks in both verbal and written formats and providing feedback on each trial and overall after each activity. Users move systematically through the programs and can track their progress as the go. Each session includes activities from several different games to maintain interest and train a variety of skills; however, games are presented in the order of domains listed above (i.e. auditory, then visual, then social, and finally executive) to avoid stimulus interference during the training.
Placebo Comparator: Computer Control
Group will receive 70 hours of computer time playing pre-selected computer games administered in a similar format as the Cognitive Remediation condition
Behavioral: Computer Control
Sessions will involve generic computer games administered via the game interface "Sporcle." Sporcle is a game site that offers a collection of quiz-type activities available on line. The activities include typing, basic timed arithmetic (e.g. simple addition); picture identification (e.g. name the corporate logo; name the sitcom), and subject-based quizzes in areas like history (e.g. name the US presidents), geography (e.g. name the state capitals), and literature (e.g. book title fill-in-the-blank). An administrator can track the activity of subjects including when they logged in, which games they played and for how long, and what their accuracy was on each game. We will use a pre-developed game schedule that includes a mix of each type of game in each session, and ensures that subjects are playing the same games in the same order. This format was developed to mirror the treatment condition, as subjects are given a variety of specific games to play at each session.
Other Name: Sporcle

Detailed Description:

Cognitive dysfunction is increasingly recognized as a major feature of bipolar disorder (BD), present by illness onset, persistent into euthymia, and associated with functional outcome. Deficits are qualitatively similar to those seen in schizophrenia (SZ), and may be quantitatively similar in some patient groups, e.g. in patients with a history of psychosis. Despite strong associations between cognitive impairment and functional outcomes in BD, treatment for these symptoms at present is inadequate. Pharmacotherapies do little to address cognitive symptoms, and may even worsen them. Psychosocial cognitive remediation (CR) treatments have been developed to target these symptoms and their functional correlates, and have shown early promise in patients with SZ in improving both neurocognition and community functioning. However, despite the overlap of neurocognitive deficits between patients with SZ and BD, no studies to date have extended neuroscience-based CR to patients with BD. The present study aims to assess the efficacy of CR treatment in patients with BD with a history of psychosis using a 70-hour CR paradigm compared to a dose-matched computer-based control. It is hypothesized that patients in the CR group will exhibit improvements in cognitive and community functioning compared to controls, which will persist during a 6-month durability phase. Additionally, putative mechanisms of functional change will be examined, including mediator effects of cognitive and clinical change on community functioning. 130 patients with BD with a history of psychosis recruited from the Psychotic Disorders Programs at McLean Hospital will be randomized into either the CR or computer control group. CR will be administered using the BrainWorks program, neuroscience-based training programs that have shown early promise in patients with SZ. Participants will be assessed on measures of clinical, cognitive, and community functioning at baseline, following the 70-hour treatment or control phase, and again 6 months later. This project is in keeping with the NIH's stated strategic priorities for improving mental health outcomes in patients and strengthening the impact of NIMH-supported research on public health, with specific recommendations for broad implementation of effective psychosocial interventions.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of BD with psychosis
  • PANSS < 75; PANSS Psychosis item scores = 3 or under; YMRS = 6 or under
  • Age between 18 and 40
  • Within 10 years of illness onset
  • Legal and mental competency of the participant

Exclusion Criteria:

  • Age under 18 or over 40
  • PANSS >75; PANSS Psychosis item scores >3; YMRS > 6
  • Legal or mental incompetence (legal incompetence defined by any guardianship (including of person or treatment guardianship); mental incompetence defined by failure of the informed consent survey)
  • Psychiatric inpatient status at time of enrollment
  • Delirium secondary to medical illness
  • Psychotic or mood disorder due to general medical or neurological illness
  • History of head trauma
  • History of seizure disorder or photo-sensitive seizures
  • Use of anticholinergic medication, clozapine or olanzapine at baseline
  • Rapid-cycling bipolar disorder
  • Diagnosis of current substance abuse (past month) or substance dependence within the past year.
  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: NCT01470781

Contacts
Contact: Sarah Sperry, B.S. 617-855-2910 ssperry@mclean.harvard.edu
Contact: Kathryn E Lewandowski, Ph.D. 617-855-2886 klewandowski@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Sarah Sperry, B.S.    617-855-2910    ssperry@mclean.harvard.edu   
Principal Investigator: Kathryn E Lewandowski, Ph.D.         
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Kathryn E Lewandowski, Ph.D. Mclean Hospital
  More Information

No publications provided

Responsible Party: Kathryn Eve Lewandowski, Assistant Research Psychologist/Instructor, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01470781     History of Changes
Other Study ID Numbers: 1K23MH091210-01A1
Study First Received: July 11, 2011
Last Updated: November 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
Bipolar Disorder
Psychosis
Cognition
Cognitive Remediation

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014