What is the mechanism of action of this treatment?

Cognitive Behavioral Therapy (CBT) works by helping patients identify and change negative thought patterns and behaviors, thereby improving emotional regulation and reducing symptoms of anxiety and depression. Cognitive Rehabilitation Therapy (CRT) focuses on enhancing cognitive functions such as memory, attention, and problem-solving through structured tasks and exercises. Lifestyle modifications, including physical activity, diet, and social engagement, aim to improve overall brain health and quality of life. These treatments are crucial for Neurocognitive Disorder patients as they address both cognitive deficits and emotional well-being, promoting better community integration and enhancing quality of life.

What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) and Cognitive Rehabilitation Therapy (CRT) are generally considered safe with minimal side effects. Some patients may experience temporary discomfort or emotional distress as they confront challenging thoughts and behaviors during therapy. Lifestyle modifications, such as changes in diet, exercise, and sleep habits, typically have positive effects but may initially cause mild side effects like fatigue or muscle soreness. Overall, these non-pharmacologic treatments are well-tolerated and have fewer side effects compared to medication-based therapies.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of neurocognitive disorders, particularly Alzheimer's disease. These include cholinesterase inhibitors like donepezil and galantamine, and NMDA receptor antagonists like memantine. These medications aim to manage symptoms and improve cognitive function. Non-pharmacological interventions, such as Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and lifestyle modifications, are also being explored for their potential benefits in improving quality of life and community integration in patients with neurocognitive disorders.

What other types of research exist?

Promising novel alternatives to Comprehensive Multimodal Intervention for Neurocognitive Disorder patients include: 1) Computer-based cognitive therapies, which have shown efficacy in improving cognitive function in conditions like aphasia. 2) Pharmacological treatments such as memantine, which has been studied for its potential benefits in various neurocognitive disorders. 3) Non-pharmacological therapies like Comprehensive Therapy (CT), which has been indicated as potentially optimal for improving cognitive function in dementia patients. These alternatives should be discussed with a healthcare provider to tailor the best treatment plan for individual needs.

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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

Summary

This trial tests if combining talking therapy, brain exercises, and lifestyle changes can help people with neurocognitive disorders live better lives by improving their thinking, brain function, and daily habits.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall experience based qualitative semi-structured interview

Secondary study objectives

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

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

Montreal Cognitive Assessment (MoCA)

+4 more

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy (CBT) works by helping patients identify and change negative thought patterns and behaviors, thereby improving emotional regulation and reducing symptoms of anxiety and depression. Cognitive Rehabilitation Therapy (CRT) focuses on enhancing cognitive functions such as memory, attention, and problem-solving through structured tasks and exercises. Lifestyle modifications, including physical activity, diet, and social engagement, aim to improve overall brain health and quality of life. These treatments are crucial for Neurocognitive Disorder patients as they address both cognitive deficits and emotional well-being, promoting better community integration and enhancing quality of life.

Treatment approaches for pusher behaviour: a scoping review.Evaluation of the Effectiveness of a Multimodal Complementary Medicine Program for Improving the Quality of Life of Cancer Patients during Adjuvant Radiotherapy and/or Chemotherapy or Outpatient Aftercare.Feasibility and acceptability of brief cognitive remediation targeting metacognition in acute inpatients with psychosis: a case series.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,833 Previous Clinical Trials

6,423,072 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

~21 spots leftby Jun 2025

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