Overview

This trial is active, not recruiting.

Conditions bipolar disorder, psychosis
Treatments brainworks, computer control
Phase phase 2
Sponsor Mclean Hospital
Collaborator National Institute of Mental Health (NIMH)
Start date June 2011
End date July 2016
Trial size 100 participants
Trial identifier NCT01470781, 1K23MH091210-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(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
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)
Group will receive 70 hours of computer time playing pre-selected computer games administered in a similar format as the Cognitive Remediation condition
computer control Sporcle
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.

Primary Outcomes

Measure
MATRICS Consensus Cognitive Battery (MCCB)
time frame: 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

Measure
Young Mania Rating Scale (YMRS)
time frame: 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)
time frame: 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)
time frame: 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)
time frame: 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
time frame: 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
fMRI (optional)
time frame: within 1 week prior to initiating intervention; post-treatment - on average 24 weeks after initiation
Probabilistic Reward Task (PRT) (optional)
time frame: within 1 week prior to initiating intervention; post-treatment - on average 24 weeks after initiation
Richards Delay Discounting
time frame: within 1 week prior to initiating intervention; post-treatment - on average 24 weeks after initiation

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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 50 - Within 10 years of illness onset - Legal and mental competency of the participant Exclusion Criteria: - 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.

Additional Information

Official title Efficacy of a Cognitive Remediation Treatment Program for Bipolar Disorder
Principal investigator Kathryn E Lewandowski, Ph.D.
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. Participants may opt to participate in an fMRI study at pre- and post-treatment; resting state, task-based and functional connectivity, and diffusion tensor imaging data will be collected to evaluate preliminary evidence of neurobiological changes after training versus control. Additionally, participants may opt in to participation in two tasks of reward sensitivity including the Probabilistic Reward task and Richard's Delay Discounting. These tasks are administered pre- and post-treatment to evaluate the role of reward in treatment response as well as the potential for CR to modulate reward processing. This project is in keeping with the NIH's stated strategic priorities for improving mental health outcomes in patients and strengthening the impact of National Institute of Mental Health (NIMH)-supported research on public health, with specific recommendations for broad implementation of effective psychosocial interventions.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mclean Hospital.