Brain Stimulation and Cognitive Training - Efficacy

Not Applicable

Completed

Interventions: Device: tDCS (Active)
Behavioral: BrainHQ
Device: tDCS (Inactive)

Brief Summary: People with serious mental illness often experience 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 helpful in improving a specific type of memory skill in people who have mental health conditions.

The study is a randomized clinical trial, meaning that participants will be randomly assigned to receive either 'active' or 'inactive' brain stimulation. All participants will complete computerized cognitive exercises, also known as cognitive training.

Overall, participants will be in the study for 6-8 weeks. The study involves 10 visits to the clinic over 2-4 weeks for cognitive training and either active or inactive brain stimulation. Participants will also complete paper-and-pencil assessments at the beginning and end of treatment, and one month after treatment ends.

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia
Willingness to participate in study procedures

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Active stimulation + cognitive training	tDCS (Active)	Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
Active stimulation + cognitive training	BrainHQ	Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
Inactive stimulation + cognitive training	tDCS (Inactive)	Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
Inactive stimulation + cognitive training	BrainHQ	Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).

Primary Outcome Measures

Name	Time	Method
Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score	Baseline to post-treatment (up to 4 weeks)	MCCB spatial span total raw score. Spatial span is a subtest of the standardized MCCB and a measure of visual working memory. Examinees must tap sequences of blocks in the same order as the examiner then in reverse. Correct responses are summed for the forward and backward condition to create a total raw score (0-32, where higher scores indicate better performance).For change scores, a positive value indicates improvement (i.e., higher total score).
Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score	Baseline to post-treatment (up to 4 weeks)	MCCB letter-number span total raw score. Letter-number span is a subtest of the standardized MCCB and a measure of verbal working memory. Examinees must reorder sequences of numbers and letters spoken out loud by the examiner. Correct responses are counted to create a total score (0-24, where higher scores indicate better performance). For change scores, a positive value indicates improvement (i.e., higher total score).

Secondary Outcome Measures

Name	Time	Method
Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A	Baseline to post-treatment (up to 4 weeks)	The Trail Making Test, part A is a subtest of the standardized MCCB and a measure of visuomotor processing/sequencing speed. Examinees must draw a line connecting numbers in ascending order as quickly as possible. Completion time in seconds is recorded (0-120, where lower scores represent better performance). For change scores, a positive value indicates improvement (i.e., faster completion time).
Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B	Baseline to post-treatment (up to 4 weeks)	Trail Making Test, part B is not part of the standardized MCCB, but is commonly administered alongside part A as a measure of speeded visuomotor switching/flexibility. Examinees must draw a line connecting numbers and letters in alternating order (e.g., 1-A-2-B). Completion time in seconds is recorded (0-300, where lower scores represent better performance). For change scores, a positive value indicates improvement (i.e., faster completion time).