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People with serious mental illness often report difficulties with thinking skills like memory. These difficulties can make it harder to perform day-to-day activities. The purpose of this study is to test whether combining a type of non-invasive brain stimulation with computerized cognitive exercises is acceptable to participants, and whether it is helpful in improving a specific type of memory skill in people who have mental health conditions and memory deficits.
This study is designed so that all participants will get both treatments: the non-invasive brain stimulation and computerized cognitive exercises. Half of the participants will start with both the brain stimulation and the cognitive exercises (dual therapy), and half will start with just the computerized exercises (monotherapy). After three weeks, participants will switch to the other condition: the people who did both treatments first will switch to just the cognitive exercises alone, and the people who started with the cognitive exercises alone will then switch to doing both the brain stimulation and cognitive exercises.
Overall, participants will be in the study for about 7-8 weeks. The brain stimulation treatment involves 10 visits to the clinic over 3 weeks. The computerized cognitive exercises can be done at home, and involve 10 hours of exercises over 3 weeks. Participants will also complete paper-and-pencil assessments at the beginning, middle, and end of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Therapy First | Experimental | Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone |
|
| Mono Therapy First | Experimental | Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant Retention in Combination Treatment | Number of participants completing every session of the combined phase of treatment | 4 weeks |
| Participant-rated Acceptability of Combination Therapy | Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction) | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Burton, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dual Therapy First | Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory |
| FG001 | Mono Therapy First | Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dual Therapy First | Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participant Retention in Combination Treatment | Number of participants completing every session of the combined phase of treatment | Posted | Count of Participants | Participants | 4 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dual Therapy First | Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cynthia Burton | University of Michigan | 7347639259 | czburton@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2020 | Aug 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Participants will be randomized to receive either dual therapy (cognitive exercises plus brain stimulation) or monotherapy (cognitive exercises alone) first; after 3 weeks participants will switch to the other condition
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| BrainHQ | Other | BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory |
|
|
| BG001 | Mono Therapy First | Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises
tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
|
|
| Primary | Participant-rated Acceptability of Combination Therapy | Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction) | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Mono Therapy First | Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory | 0 | 6 | 0 | 6 | 0 | 6 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |