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Clinical Trials/NCT03338673
NCT03338673
Completed
Not Applicable

Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.

University of Michigan1 site in 1 country12 target enrollmentOctober 11, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bipolar Disorder
Sponsor
University of Michigan
Enrollment
12
Locations
1
Primary Endpoint
Participant Retention in Combination Treatment
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 11, 2018
End Date
September 27, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cynthia Burton

Clinical Lecturer, Department of Psychiatry

University of Michigan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Participant Retention in Combination Treatment

Time Frame: 4 weeks

Number of participants completing every session of the combined phase of treatment

Participant-rated Acceptability of Combination Therapy

Time Frame: 8 weeks

Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction)

Study Sites (1)

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