Treatment to Enhance Cognition in Bipolar Disorder

NCT01470781 | Completed Results

• 2 other identifiers: 1K23MH091210-01A1K23MH091210
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder; Psychosis

Keywords

Bipolar Disorder; Psychosis; Cognition; Cognitive Remediation

Outcome Measures

Primary Outcomes (1)

• MATRICS Consensus Cognitive Battery (MCCB)

  The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery includes 10 tasks that are designed to measure seven key cognitive domains: processing speed, attention, working memory, verbal learning, visual learning, problem solving and social cognition. These scores are also combined to yield a cognitive Composite. All subtest, domain, and composite scores are reported in standardized T scores with a mean of 50 and a standard deviation of 10; higher scores reflect better performance. For example, a score of 60 on any subtest, domain, or the Composite would represent a score 1 standard deviation above than the mean. All standardized scores are computed by the MCCB scoring software included in the testing battery, and are normed by age and sex. Total administration time is 60-90 minutes.

  within 1 week prior to initiating intervention; midpoint - on average 8 weeks after initiation; post-treatment - on average 24 weeks after initiation; after 6 months no active intervention

Secondary Outcomes (5)

• Young Mania Rating Scale (YMRS)

  within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention

• Montgomery-Asberg Depression Rating Scale (MADRS)

  within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention

• Positive and Negative Syndrome Scale (PANSS)

  within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention

• Multnomah Community Ability Scale (MCAS)

  within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention

• Social and Occupational Functioning Assessment Scale

  within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention

Other Outcomes (1)

• Functional Magnetic Resonance Imaging (fMRI) (Optional)

  within 1 week prior to initiating intervention; post-treatment - on average 24 weeks after initiation

Study Arms (2)

Cognitive Remediation

EXPERIMENTAL

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

Computer Control

PLACEBO COMPARATOR

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

Interventions

BrainWorks BEHAVIORAL

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.

Cognitive Remediation

Computer Control BEHAVIORAL

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.

Also known as: Sporcle

Computer Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of BD with psychosis
• Positive and Negative syndrome Scale (PANSS) \< 75; PANSS Psychosis item scores = 3 or under; Young Mania Rating Scale (YMRS) = 6 or under
• Age between 18 and 50
• Within 10 years of illness onset
• Legal and mental competency of the participant

You may not qualify if:

• Age under 18 or over 50
• 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.

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (2)

• Lewandowski KE, Sperry SH, Cohen BM, Norris LA, Fitzmaurice GM, Ongur D, Keshavan MS. Treatment to Enhance Cognition in Bipolar Disorder (TREC-BD): Efficacy of a Randomized Controlled Trial of Cognitive Remediation Versus Active Control. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1242-e1249. doi: 10.4088/JCP.17m11476.

  PMID: 29045770 DERIVED

• Lewandowski KE, Sperry SH, Ongur D, Cohen BM, Norris LA, Keshavan MS. Cognitive remediation versus active computer control in bipolar disorder with psychosis: study protocol for a randomized controlled trial. Trials. 2016 Mar 12;17(1):136. doi: 10.1186/s13063-016-1275-7.

  PMID: 26969299 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Psychotic Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

• Title: Dr. Kathryn Lewandowski
• Organization: McLean Hospital/Harvard Medical School

klewandowski@mclean.harvard.edu

617-855-2886

Study Officials

• Kathryn E Lewandowski, Ph.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: assessment staff, investigator, and participants blind to group membership.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist/Assistant Professor

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: November 11, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 28, 2021
• Results First Posted: February 26, 2020

Record last verified: 2021-08

Locations

US (1)