Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study
- Conditions
- Childhood-onset Bipolar DisorderPediatric Bipolar DisorderBipolar Disorder
- Interventions
- Behavioral: COGFLEX-control conditionBehavioral: COGFLEX-skill building levels
- Registration Number
- NCT01954680
- Lead Sponsor
- Bradley Hospital
- Brief Summary
The main aim of this study is to test a new, non-medication computer-based potential treatment for bipolar disorder in children and adolescents.
In the study, children and adolescents with bipolar disorder will come to our lab at Bradley Hospital 2-times per week for 8-weeks to "play" a custom computer "game" designed to retrain the brain--to build a skill that my work has shown is impaired in children/adolescents with bipolar disorder.
Before and after this 8-week trial, children will have a special magnetic resonance imaging (MRI) scan.
This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.
If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.
- Detailed Description
Prior studies have shown that "computer assisted cognitive remediation"--meaning using computer "games" to build up a skill that has been shown to be impaired in a specific disorder--can result in improvement in psychiatric illnesses--including schizophrenia.
This will be the first National Institute of Mental Health (NIMH)-funded study to use this "retrain your brain" approach in children and adolescents with bipolar disorder.
During this study, we are seeking 40 children and adolescents with bipolar disorder to:
* come to our lab at Bradley Hospital in East Providence R.I. twice per week (each lasting 1 hour) to "play" a special computer game for a total of 8 weeks
* to have a special MRI before and after this 8-week trial to see if our "game" improves brain activity
* it does NOT matter if your child is already on medications--they can continue during this study
* all children/adolescents with bipolar disorder are welcome--as long as they do NOT have implanted metal (no braces, no cochlear implants, etc) because of magnetic resonance imaging (MRI) safety.
This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.
If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 7-17 years old
- bipolar disorder type I preferred (at least 1 week of mania)
- no implanted metal (no braces, no cochlear implants)
- can not have full Diagnostic and Statistical Manual 4th Edition (DSM-IV) autistic disorder
- no active drug/alcohol abuse/dependence
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COGFLEX-control condition COGFLEX-control condition In the R33, children will be randomized to receive either COGFLEX with skill-building levels or the control condition--which is just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks. COGFLEX-skill building levels COGFLEX-skill building levels In the R33, children will be randomized to receive either COGFLEX with skill-building levels or just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks.
- Primary Outcome Measures
Name Time Method Change in functional magnetic resonance imaging (fMRI) brain activation Change from week 1 to week 8 We will compare functional magnetic resonance imaging (fMRI) brain activation from week 1 (before intervention starts) to week 8 (after intervention is complete).
- Secondary Outcome Measures
Name Time Method Change in Clinician global Impression Improvement-Irritability Change from week 1 to week 8 Clinician global Impression Improvement-Irritability
Trial Locations
- Locations (1)
Bradley Hospital
🇺🇸East Providence, Rhode Island, United States