Mild Cognitive ImpairmentCoINTEGRATENCT05854290
Comprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) for Foreign-Born Arab Americans
A study testing CRT, CBT and Modifiable lifestyle factors in people with Mild Cognitive Impairment, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate the feasibility of a cognitive and affective intervention for foreign born Arab American dyads consisting of the person with Mild Cognitive Impairment (MCI) and participants caregiver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- CRT, CBT and Modifiable lifestyle factors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2023to 9 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients diagnosed with MCI or Persons with Montreal Cognitive Assessment (MoCA) less or equal to 25
- Disease duration less or equal to 3 years
- Age older than 60 years
- Foreign-Born Arab origins, Language: Arabic or English
- 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)
- Participants who can provide consent or legally authorized representative who can provide consent on their behalf
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- Identified by the patients as the person that provides the most care for them with regards to medical care; may be a spouse, an adult child, a sibling, a relative, or family friend
- Above the age of 18 years Fluent in Arabic and/or English
- Can complete a self-report questionnaire by interview or self-report.
Who cannot join
- History of traumatic brain injury (TBI)
- Diagnosed with Covid-19
- Patients with other neurosensory or neurodegenerative diseases
- Younger than 60 years
- Psychiatric disorders other than mild to moderate anxiety and depression
- Diagnosed sleep disorders
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- Visual or auditory impairment
- Current or history of alcohol or substance abuse/dependence
- Patients with severe depression or suicidal (ideation or plan) will be instructed to seek mental health, provided with resources, and referred to their primary care provider
- Paid caregivers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Trial of a Comprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) (CoINTEGRATE- for Foreign-Born Arab Americans- a Dyadic Approach)
The purpose of this pilot study is to evaluate the feasibility of a cognitive and affective intervention for foreign born Arab American dyads consisting of the person with Mild Cognitive Impairment (MCI) and participants caregiver. This study will evaluate the feasibility of a cognitive and affective intervention combining Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle factors to address the cognitive and affective dysfunctions associated with Mild Cognitive Impairment (MCI) or those with cognitive complaints.
The study team hypothesizes that combining evidence-based cognitive and affective therapies (CRT+CBT) with lifestyle modifications is feasible and will improve the cognitive performance and Quality of Life (QoL) in patients with MCI and participants caregivers compared to usual care.
- Conditions
- Mild Cognitive Impairment
- Being tested
- CRT, CBT, Modifiable lifestyle factors, Usual care Psychoeducation
- Keywords
- Caregiver, Quality of life, Cognitive Behavioral Therapy, Modifiable lifestyle factors, Cognitive Rehabilitation Therapy, Arab American
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRTBehavioural
Participants will complete an 8-week intervention, 2 sessions per week. Co-INTEGRATE sessions take 30-50 minutes to complete. Weekly on the day of the last therapy session, before or after the session, all patients, regardless of the group assigned to, will be asked to complete an electronic brief questionnaire to provide information, on sleep, recreational habits, alcohol intake, exercise, and smoking.
CBTBehavioural
Participants will complete an 8-week intervention, 2 sessions per week. Co-INTEGRATE sessions take 30-50 minutes to complete. Weekly on the day of the last therapy session, before or after the session, all patients, regardless of the group assigned to, will be asked to complete an electronic brief questionnaire to provide information, on sleep, recreational habits, alcohol intake, exercise, and smoking.
Modifiable lifestyle factorsBehavioural
The therapy sessions are coupled with homework and requires some lifestyle modifications for the persons with MCI, such lifestyle adjustments are using a calendar, a diary, maintaining a sleep schedule and exercise.
Usual care PsychoeducationBehavioural
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).
Weekly on the day of the last therapy session, before or after the session, all patients, regardless of the group assigned to, will be asked to complete an electronic brief questionnaire to provide information, on sleep, recreational habits, alcohol intake, exercise, and smoking.
| Study group | Role | What they receive |
|---|---|---|
| CRT plus CBT and Lifestyle modifications | Experimental | Not described Receives: Behavioral: CRT; Behavioral: CBT; Behavioral: Modifiable lifestyle factors |
| Usual care Psychoeducation | Active comparator | Not described Receives: Behavioral: Usual care Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that complete the study
Measured: week 8 (end of treatment)
Average number of sessions completed
Measured: 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.
Measured: Week 9 (after treatment ended)
Secondary outcomes (6)
The Short Form Health Survey (SF-36)
The SF-36 explores people's physical and mental health. It consists of 36 items that assess role limitations due to personal or emotional problems, emotional well-being, social functioning, general health perceptions, perceived change in health. Scores ranged from 0 (worst health status) to 100 (best health status).
Measured: Week 9 (after treatment ended)
The Symbol Digit Modalities Test Score (SDMT-5 minutes)
The Symbol Digit Modalities Test (SDMT) is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Because examinees can give either written or spoken responses, the test is well suited for use with individuals who have motor disabilities or speech disorders. Because it involves only geometric figures and numbers, the SDMT is relatively culture free as well and can be administered to individuals who do not speak English. It takes approximately 5 minutes to complete the entire test. Scoring involves summing the number of correct substitutions within the 90 second interval the max score is 110, where a higher score indicates a better memory
Measured: Week 9 (after treatment ended)
Brief Visuospatial Memory test (BVMT-R-25 minutes)
This test is comprised of three memory trials (10 seconds each) followed by delayed recall after 25 minutes and a recognition trial. It has been widely used as a quick measure of visuospatial memory. The digital stimulus forms will be used (alternate form will be used at the end of the study to control for practice effect).
Recall performance will record for each of the immediate recall trials (Trial 1, Trial 2, and Trial 3) and for the delayed recall trial (Delayed Recall). The study team will combine the recall scores to form three additional summary measures of learning and memory. Recognition Hits and False Alarms will be recorded during the delayed recognition task. Recognition Hits are calculated as the number of correct responses to target items, and Recognition False Alarms are calculated as the number of incorrect responses to nontarget items. Each trial is worth 0-12 points, so the total score is 0-36, a higher score indicates a better memory.
Measured: Week 9 (after treatment ended)
California Verbal Learning Test-Third Edition (CVLT-3-60 minutes)
The California Verbal Learning Test, Third Edition (CVLT-3) measures both recall and recognition of two lists of words (List A and List B) over a number of immediate and delayed memory trials. It provides an assessment of verbal learning and memory deficits in adults ages 16 - 90. Score of 0-16, where a lower score indicates worse memory, and a high score indicates better memory.
Measured: Week 9 (after treatment ended)
The Memory Complaint Scale (MCS-2 minute) score
The Memory Complaint Scale (MCS-2 min) is comprised of 14 items and is designed for subjective memory complaints.The test yields a total score with a classification in terms of memory complaint (MC) based on their score as follows: No MC (0-2), mild MC (3-6), moderate MC (7-10) or severe MC (11-14)
Measured: Week 9 (after treatment ended)
Arabic Verbal Memory Test (VMAT)
The Arabic Verbal Memory Test is a verbal memory test that consists of 3 lists (List A, List B (each 15 words), and a Recognition List (45 words). It assesses verbal learning and memory in adults aged 16-90. The scores will include scores on learning trials 1-5, free and cued short recall, interference trial free recall and delayed free and cued recall, yes/ no recognition, and forced choice recognition. The test yields a score of 0-15, where a lower score indicates worse memory and a high score indicates better memory.
Measured: Week 9 (after treatment ended)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start3 May 2023
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Why it stopped: Difficulties with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Caregiver and patient dyads will be randomly assigned to receive either CRT plus CBT, or usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Darwish, University of Michigan
- Investigators
- Hala Darwish, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854290
- Sponsor's protocol ID
- HUM00227630
- Acronym
- CoINTEGRATE
- Status last verified
- Dec 2024
- First submitted
- 2 May 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of a Comprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) (CoINTEGRATE- for Foreign-Born Arab Americans- a Dyadic Approach)
- ClinicalTrials.gov ID
- NCT05854290
- Acronym / sponsor ID
- CoINTEGRATE / HUM00227630
- Conditions
- Mild Cognitive Impairment
- Keywords
- Caregiver, Quality of life, Cognitive Behavioral Therapy, Modifiable lifestyle factors, Cognitive Rehabilitation Therapy, Arab American
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to evaluate the feasibility of a cognitive and affective intervention for foreign born Arab American dyads consisting of the person with Mild Cognitive Impairment (MCI) and participants caregiver. This study will evaluate the feasibility of a cognitive and affective intervention combining Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle factors to address the cognitive and affective dysfunctions associated with Mild Cognitive Impairment (MCI) or those with cognitive complaints.
The study team hypothesizes that combining evidence-based cognitive and affective therapies (CRT+CBT) with lifestyle modifications is feasible and will improve the cognitive performance and Quality of Life (QoL) in patients with MCI and participants caregivers compared to usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Caregiver and patient dyads will be randomly assigned to receive either CRT plus CBT, or usual care.
| Arm | Type | Receives |
|---|---|---|
| CRT plus CBT and Lifestyle modifications | Experimental | Behavioral: CRT, Behavioral: CBT, Behavioral: Modifiable lifestyle factors |
| Usual care Psychoeducation | Active comparator | Behavioral: Usual care Psychoeducation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All patients diagnosed with MCI or Persons with Montreal Cognitive Assessment (MoCA) less or equal to 25
- Disease duration less or equal to 3 years
- Age older than 60 years
- Foreign-Born Arab origins, Language: Arabic or English
- 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)
Key exclusion criteria (10 listed)
- History of traumatic brain injury (TBI)
- Diagnosed with Covid-19
- Patients with other neurosensory or neurodegenerative diseases
- Younger than 60 years
- Psychiatric disorders other than mild to moderate anxiety and depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRTParticipants will complete an 8-week intervention, 2 sessions per week. Co-INTEGRATE sessions take 30-50 minutes to complete. Weekly on the day of the last therapy session, before or after the session, all patients, regardless of the group assigned to, will be asked to complete an electronic brief questionnaire to provide information, on sleep, recreational habits, alcohol intake, exercise, and smoking. | Behavioural | CRT plus CBT and Lifestyle modifications |
| CBTParticipants will complete an 8-week intervention, 2 sessions per week. Co-INTEGRATE sessions take 30-50 minutes to complete. Weekly on the day of the last therapy session, before or after the session, all patients, regardless of the group assigned to, will be asked to complete an electronic brief questionnaire to provide information, on sleep, recreational habits, alcohol intake, exercise, and smoking. | Behavioural | CRT plus CBT and Lifestyle modifications |
| Modifiable lifestyle factorsThe therapy sessions are coupled with homework and requires some lifestyle modifications for the persons with MCI, such lifestyle adjustments are using a calendar, a diary, maintaining a sleep schedule and exercise. | Behavioural | CRT plus CBT and Lifestyle modifications |
| Usual care PsychoeducationParticipants 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). Weekly on the day of the last therapy session, before or after the session, all patients, regardless of the group assigned to, will be asked to complete an electronic brief questionnaire to provide information, on sleep, recreational habits, alcohol intake, exercise, and smoking. | Behavioural | Usual care Psychoeducation |
Primary outcome
Number of patients that complete the study
Time frame: week 8 (end of treatment)
Average number of sessions completed
Time frame: week 8 (end of treatment)
Overall experience based qualitative semi-structured interview
Time frame: Week 9 (after treatment ended)
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.
6 secondary outcomes
The Short Form Health Survey (SF-36)
Time frame: Week 9 (after treatment ended)
The Symbol Digit Modalities Test Score (SDMT-5 minutes)
Time frame: Week 9 (after treatment ended)
Brief Visuospatial Memory test (BVMT-R-25 minutes)
Time frame: Week 9 (after treatment ended)
California Verbal Learning Test-Third Edition (CVLT-3-60 minutes)
Time frame: Week 9 (after treatment ended)
The Memory Complaint Scale (MCS-2 minute) score
Time frame: Week 9 (after treatment ended)
Arabic Verbal Memory Test (VMAT)
Time frame: Week 9 (after treatment ended)
Results and safety
The study was stopped early (reason given: Difficulties with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala Darwish, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT, CBT and Modifiable lifestyle factors in people with Mild Cognitive Impairment, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties with recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that complete the study (time frame: week 8 (end of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.