COMPLETED

A Pilot Randomized Controlled Trial: CoINTEGRATE

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Conditions

Neurocognitive DisordersCognitive DysfunctionTraumatic Brain InjuryMultiple SclerosisMild Cognitive ImpairmentAffective DysfunctionCognitive Behavioral TherapyModifiable lifestyle factorsCognitive Rehabilitation TherapyLong COVID (coronavirus disease)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Randomized Controlled Trial of A Comprehensive Cognitive and Affective Intervention for Neurocognitive Disorders (CoINTEGRATE)

Quick Facts

Study Start:2023-09-01
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05732285

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with one of the following: Mild Trauma Brain injury (TBI), Multiple Sclerosis (MS), Long COVID, or Mild Cognitive Impairment (MCI)
  2. * MCI patients age older than 50 years old, all other diagnosis 21-65 years old and are receiving care through the Michigan medicine network
  3. * Participants that can provide consent or legally authorized representative who can provide consent on their behalf
  4. * 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)
  1. * TBI participants symptomatic at rest (headache, dizziness, nausea, or vertigo) will be referred to primary care physician (PCP)
  2. * History of TBI (except for participants with TBI)
  3. * MS participants with recent relapse (1 month prior to enrollment) or on Intravenous or oral steroids
  4. * MCI participants with disease duration greater than 1 year
  5. * Patients with other neurosensory or neurodegenerative diseases
  6. * Diagnosed with COVID-19 (except for Long COVID group)
  7. * Psychiatric disorders other than mild to moderate anxiety and depression
  8. * 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
  9. * Diagnosed sleep disorders
  10. * Visual or auditory impairment,
  11. * Current or history of alcohol or substance abuse/dependence
  12. * 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)
  13. * 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)
  14. * Currently receiving CRT, CBT or Occupational therapy (OT) or another type of psychological therapy

Contacts and Locations

Principal Investigator

Hala Darwish, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Hala Darwish, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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