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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH096850 | U.S. NIH Grant/Contract | View source | |
| R33MH096850 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COGFLEX-skill building levels | Experimental | 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. |
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| COGFLEX-control condition | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COGFLEX-skill building levels | Behavioral | COGFLEX--in English-- is a computer game designed to build up a specific skill that our work has shown is impaired in children and adolescents with bipolar disorder). In the R33, children will be randomized to receive either COGFLEX with skill-building levels or COGFLEX-control condition which is just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks. This same approach has shown great success in many psychiatric disorders including schizophrenia. This is the first such study in children/adolescents with bipolar disorder. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in functional magnetic resonance imaging (fMRI) brain activation | We will compare functional magnetic resonance imaging (fMRI) brain activation from week 1 (before intervention starts) to week 8 (after intervention is complete). | Change from week 1 to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician global Impression Improvement-Irritability | Clinician global Impression Improvement-Irritability | Change from week 1 to week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Dickstein, M.D. | Bradley Hospital/Alpert Medical School of Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bradley Hospital | Recruiting | East Providence | Rhode Island | 02915 | United States |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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R21 phase was an open phase 1a trial for feasibility and acceptability with enrollment goal including intervention development of 20.
R33 phase enrollment goal of 40 including double-blind placebo-controlled randomized trial of 2 versions of video game potential intervention.
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Neither participant nor independent evaluator knows group assignment in R33 phase randomized controlled trial.
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| COGFLEX-control condition | Behavioral | In the R33, the control condition will be the same COGFLEX "game"--but just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks. |
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