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Combination Therapies + Lifestyle Modifications for Traumatic Brain Injury (CoINTEGRATE Trial)

N/A

Recruiting

Led By Hala Darwish, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 9 (after treatment ended)

Awards & highlights

CoINTEGRATE Trial Summary

This trial will test if a combination of therapies and lifestyle modifications can help improve the quality of life and integration of people with neurocognitive disorders.

Who is the study for?

This trial is for adults over 50 with mild cognitive impairment (MCI) or those aged 21-65 with traumatic brain injury (TBI), multiple sclerosis (MS), or long COVID, experiencing certain levels of cognitive decline. They must be part of the Michigan medicine network and able to consent. Excluded are individuals with severe depression, suicidal thoughts, other major neurological conditions, recent MS relapse, diagnosed sleep disorders, sensory impairments, substance abuse issues, or currently in similar therapies.Check my eligibility

What is being tested?

The CoINTEGRATE study tests a tailored mix of Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and lifestyle changes against usual care to see if it improves life quality and community integration for people with neurocognitive disorders resulting from TBI or MS.See study design

What are the potential side effects?

Since this trial involves therapy and lifestyle adjustments rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort when discussing personal issues during CBT sessions.

CoINTEGRATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 9 (after treatment ended)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 9 (after treatment ended)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 9 (after treatment ended) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average number of sessions completed

Number of patients that complete the study

Overall experience based qualitative semi-structured interview

Secondary outcome measures

Brief Visuospatial Memory test (BVMT-R-25 minutes)

California Verbal Learning Test-Third Edition (CVLT-3-60 minutes)

Montreal Cognitive Assessment (MoCA)

+4 more

CoINTEGRATE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CRT plus CBT and Lifestyle modificationsExperimental Treatment3 Interventions

Group II: Usual careActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CRT

2008

Completed Phase 4

~860

CBT

2013

Completed Phase 3

~4220

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,797 Previous Clinical Trials

6,378,002 Total Patients Enrolled

Hala Darwish, PhDPrincipal InvestigatorUniversity of Michigan

1 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

CBT Clinical Trial Eligibility Overview. Trial Name: NCT05732285 — N/A

Neurocognitive Disorder Research Study Groups: Usual care, CRT plus CBT and Lifestyle modifications

Neurocognitive Disorder Clinical Trial 2023: CBT Highlights & Side Effects. Trial Name: NCT05732285 — N/A

CBT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05732285 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction that precludes those under 60 years old from participating in this experiment?

"Those between 21 years old and 65 years of age may take part in the trial, provided they meet all other eligibility criteria."

Answered by AI

Are there any opportunities to participate in this investigation at present?

"The information hosted on clinicaltrials.gov confirms that this medical trial is currently recruiting patients. This study was posted to the public domain as of March 30th 2023 and revised most recently on February 7th 2023."

Answered by AI

How many participants are being administered the intervention in this trial?

"Affirmative. As evidenced on clinicaltrials.gov, this research endeavour is currently recruiting participants and was first posted on March 30th 2023 with its most recent amendment occurring February 7th 2023. 56 individuals are required to be enrolled at a single medical centre."

Answered by AI

What criteria must a person meet in order to qualify for this experiment?

"This clinical trial is actively seeking 56 people aged between 21 and 65 who suffer from multiple sclerosis. The following criteria must also be met: a MCI patient above the age of 50, cognitive impairment greater than 1 standard deviation lower compared to norms for their respective age and educational background on at least two domains (verbal learning/memory, processing speed or visuospatial memory), diagnosed with mild TBI, MS, long COVID or MCI accompanied by consent from either themselves or an authorized representative."

Answered by AI

What are the specific objectives of this clinical experiment?

"This clinical trial's primary goal is to measure the average number of sessions completed by week 8. Secondary objectives include collecting data on physical and mental health through administering the Short Form Health Survey (SF-36), testing cognitive function with Montreal Cognitive Assessment (MoCA) as well as motor speed and visual scanning ability using Symbol Digit Modalities Test Score (SDMT-5 minutes)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Pilot Randomized Controlled Trial: CoINTEGRATE

Hala Darwish 2023. "A Pilot Randomized Controlled Trial: CoINTEGRATE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05732285.

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