Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05352568 |
| Other study ID # |
2105211050 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2, 2022 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Alliant International University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the study is to evaluate the feasibility of implementing cognitive training
with 40 patients living with schizophrenia and schizoaffective disorder. The study aims to
explore if cognitive training as an intervention can improve cognition, symptomology, social
cognition, and psychosocial function which has been determined through literature to be
impacted within this population. The results of this study will help shed light on utilizing
additional resources to aid in decreasing relapse and continued hospitalizations.
Description:
After being selected for this study based on a screening survey, participants will be asked
to fill out a demographic questionnaire, the Multidimensional Schizotypy Scale - Brief
Version (MSS-B), the Montreal Cognitive Assessment (MoCA), the Davos Assessment of Cognitive
Biases Scale (DACOBS), and the Illness Management and Recovery Scale - Consumer Self-Rating,
IMRS. The measurements evaluate different aspects of severe mental illness which are often
challenges. This will take approximately: the screener questionnaire (2-3 minutes),
demographic questionnaire (3-5 minutes), MSS-B (38 questions: 10-15 minutes), MoCA (10-15
minutes), DACOBS (42 questions: 15-20 minutes), and IMS (15 questions: 5 to 15 minutes)-
Total Maximum Time is 63 minutes. After all, measurements are completed, the participants
will be introduced to the BrainHQ program the following week. The participants will begin the
selected cognitive training module 3 times a week (Mon, Wed, and Fri), 60 minutes per session
for a total of 180 minutes per week. The participants will have a total of 24 sessions over
the course of 8 weeks, for a total of 1,440 minutes of cognitive training over the course of
this feasibility study. A process questionnaire on the acceptability/ feasibility of the
cognitive training program will be administered after the first session, then the middle
progress point (4th week), and at the end of the program (8th week) (2-3 minutes). Upon
completion of the cognitive training, the participants will retake each measurement (MSS-B,
MoCA, DACOBS, and IMRS)-Total Maximum Time is 55 minutes. There is minimal to no risk in this
study. Participants will continue their prescribed treatment plan with the addition of the
cognitive training which is computerized and takes the form of simulated games with an
attended purpose. Participants will continue to be monitored by their providers and staff
will continue to evaluate participants for changes in baseline behavior on a daily basis
during the course of the study. The plan analysis for this study will be a MANOVA and
Correlations. Confidentiality of research records and data will be protected in accordance
with the Alliant International University Institutional Review Boards policies, and
procedures.
