Bipolar Disorder, Schizo Affective Disorder, Schizophrenia
Conditions
Brief summary
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.
Interventions
DEVICEtDCS
tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
OTHERBrainHQ
BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia * Objective cognitive impairment in working memory * Willingness to complete computerized cognitive training and undergo brain stimulation procedures
Exclusion criteria
* History of neurological illness or brain injury (e.g., stroke) * History of loss of consciousness * Diagnosed intellectual disability * Current substance use disorder * Current mania or moderate depression or severe psychosis * Serious suicidal ideation/behavior * Pregnant or trying to become pregnant, or currently lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Retention in Combination Treatment | 4 weeks | Number of participants completing every session of the combined phase of treatment |
| Participant-rated Acceptability of Combination Therapy | 8 weeks | Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| 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 | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Mono Therapy First | Total | Dual Therapy First |
|---|---|---|---|
| Age, Continuous | 48.83 years STANDARD_DEVIATION 13.41 | 48.75 years STANDARD_DEVIATION 13.06 | 48.67 years STANDARD_DEVIATION 13.98 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 8 Participants | 3 Participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
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)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Therapy First | Participant-rated Acceptability of Combination Therapy | 9.40 units on a scale | Standard Deviation 0.89 |
| Mono Therapy First | Participant-rated Acceptability of Combination Therapy | 8.60 units on a scale | Standard Deviation 2.07 |
Primary
Participant Retention in Combination Treatment
Number of participants completing every session of the combined phase of treatment
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dual Therapy First | Participant Retention in Combination Treatment | 4 Participants |
| Mono Therapy First | Participant Retention in Combination Treatment | 5 Participants |