A Pilot Randomized Controlled Trial: CoINTEGRATE

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

September 1, 2025

Study Completion Date

October 1, 2025

Conditions
Neurocognitive DisordersCognitive DysfunctionTraumatic Brain InjuryMultiple SclerosisMild Cognitive Impairment
Interventions
BEHAVIORAL

CRT

"Participants that score 1-1.5 standard deviation (SD) below the norm for age and education on 2 cognitive domains will receive an intensive program, 2 CRT sessions per week for 4 weeks in addition to 1 CBT session per week for 8 weeks. Based on clinical experience, those with more severe cognitive deficits require more time to achieve their therapy goals, whereas those with mild deficits can tolerate a more intense therapy.~Participants that score 1.5-2 SD or more below the norm for age and education on 2 cognitive domains will receive 1 CRT and 1 CBT weekly sessions for 8 weeks. All the CRT sessions will be coupled with homework for 8 weeks.~All research-related sessions will be web-based (on Zoom) and recorded (with approval)."

BEHAVIORAL

CBT

"Participants that score 1-1.5 standard deviation (SD) below the norm for age and education on 2 cognitive domains will receive an intensive program, 2 CRT sessions per week for 4 weeks in addition to 1 CBT session per week for 8 weeks. Based on clinical experience, those with more severe cognitive deficits require more time to achieve their therapy goals, whereas those with mild deficits can tolerate a more intense therapy.~Participants that score 1.5-2 SD or more below the norm for age and education on 2 cognitive domains will receive 1 CRT and 1 CBT weekly sessions for 8 weeks. All the CRT sessions will be coupled with homework for 8 weeks.~All research-related sessions will be web-based (on Zoom) and recorded (with approval)."

BEHAVIORAL

Modifiable lifestyle factors

The therapy sessions are coupled with homework and requires some lifestyle modifications such lifestyle adjustments are using a calendar, a diary, maintaining a sleep schedule and exercise.

BEHAVIORAL

Usual care Psychoeducation

"Participants will receive 15 minute psychoeducation session twice per week for 8 weeks.~All research-related sessions will be web-based (on Zoom) and recorded (with approval)."

Trial Locations (1)

48109

University of Michigan, Ann Arbor

All Listed Sponsors
lead

University of Michigan

OTHER

NCT05732285 - A Pilot Randomized Controlled Trial: CoINTEGRATE | Biotech Hunter | Biotech Hunter