A Pilot Randomized Controlled Trial: CoINTEGRATE

NCT05732285 | Completed

• 1 other identifier: HUM00210257
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the feasibility of comprehensive multimodal individually tailored Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle sessions. The study team hypothesizes that combining evidence-based cognitive and affective therapies with lifestyle modifications is feasible and will improve the community integration (CI) and Quality of life (QoL) in patients with a neurocognitive disorder compared to usual care.

Conditions

Neurocognitive Disorders; Cognitive Dysfunction; Traumatic Brain Injury; Multiple Sclerosis; Mild Cognitive Impairment

Keywords

Affective Dysfunction; Cognitive Behavioral Therapy; Modifiable lifestyle factors; Cognitive Rehabilitation Therapy; Long COVID (coronavirus disease)

Outcome Measures

Primary Outcomes (3)

• Number of patients that complete the study

  week 8 (end of treatment)

• Average number of sessions completed

  week 8 (end of treatment)

• Overall experience based qualitative semi-structured interview

  This interview will be conducted at the end of the study and in the order of exit of participants to gather feedback about their satisfaction with the study. This brief interview consists of 3 questions that ask the participants to describe the aspects of the intervention participants found beneficial, willingness to participate again, and whether it was appropriate for participants needs. In addition, a brief quantitative satisfaction survey to rate overall satisfaction, how likely it would be recommend to others, and how satisfied participants are with telemedicine as a mode of delivery.

  Week 9 (after treatment ended)

Secondary Outcomes (7)

• The Community Integration Questionnaire (CIQ) Score

  Week 9 (after treatment ended)

• The Short Form Health Survey (SF-36)

  Week 9 (after treatment ended)

• Montreal Cognitive Assessment (MoCA)

  Week 9 (after treatment ended)

• The Symbol Digit Modalities Test Score (SDMT-5 minutes)

  Week 9 (after treatment ended)

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

  Week 9 (after treatment ended)

Study Arms (2)

CRT plus CBT and Lifestyle modifications

EXPERIMENTAL

Behavioral: CRT; Behavioral: CBT; Behavioral: Modifiable lifestyle factors

Usual care

ACTIVE COMPARATOR

Behavioral: Usual care Psychoeducation

Interventions

CRT BEHAVIORAL

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).

CRT plus CBT and Lifestyle modifications

CBT BEHAVIORAL

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).

CRT plus CBT and Lifestyle modifications

Modifiable lifestyle factors BEHAVIORAL

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.

CRT plus CBT and Lifestyle modifications

Usual care Psychoeducation BEHAVIORAL

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).

Usual care

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with one of the following: Mild Trauma Brain injury (TBI), Multiple Sclerosis (MS), Long COVID, or Mild Cognitive Impairment (MCI)
• MCI patients age older than 50 years old, all other diagnosis 21-65 years old and are receiving care through the Michigan medicine network
• Participants that can provide consent or legally authorized representative who can provide consent on their behalf
• Cognitive impairment ≥ 1.0 standard deviation below the test score normed for age and education in at least 2 cognitive domains (verbal learning and memory, processing speed, or visuospatial memory)

You may not qualify if:

• TBI participants symptomatic at rest (headache, dizziness, nausea, or vertigo) will be referred to primary care physician (PCP)
• History of TBI (except for participants with TBI)
• MS participants with recent relapse (1 month prior to enrollment) or on Intravenous or oral steroids
• MCI participants with disease duration greater than 1 year
• Patients with other neurosensory or neurodegenerative diseases
• Diagnosed with COVID-19 (except for Long COVID group)
• Psychiatric disorders other than mild to moderate anxiety and depression
• Patients with severe depression or suicidal (ideation or plan) will be instructed to seek mental health, provided with resources and referred to patient's primary care provider
• Diagnosed sleep disorders
• Visual or auditory impairment,
• Current or history of alcohol or substance abuse/dependence
• Cognitive impairment less than 1.0 standard deviation below the test score normed for age and education in at least 2 cognitive domains (verbal learning and memory, processing speed, or visuospatial memory)
• Cognitive impairment greater or equal to 1.0 standard deviation below the test score normed for age and education in 1 cognitive domain (verbal learning and memory, processing speed, or visuospatial memory)
• Currently receiving CRT, CBT or Occupational therapy (OT) or another type of psychological therapy

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Neurocognitive Disorders; Cognitive Dysfunction; Brain Injuries, Traumatic; Multiple Sclerosis; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Mental Disorders; Cognition Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hala Darwish, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Only the data collectors in this study will be blind to the patient's group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nursing

Model Details: CRT plus CBT plus lifestyle modification or usual care

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 17, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)