- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07451821
Cognitive Disengagement Syndrome in Functional Neurological Symptom Disorder
Symptoms of Sluggish Cognitive Tempo/Cognitive Disengagement Syndrome in Functional Neurological Symptom Disorder/Conversion Disorder: A Cross-Sectional Case-Control Study
Study Overview
Status
Conditions
Detailed Description
Sluggish Cognitive Tempo (SCT), also referred to as Cognitive Disengagement Syndrome (CDS), is characterized by symptoms such as excessive daydreaming, mental fogginess, lethargy, slowed behavior, confusion, and reduced alertness. Research indicates that SCT/CDS symptoms are distinct from attention deficit hyperactivity disorder (ADHD), although some overlap may occur. Studies suggest that SCT/CDS may be influenced more by environmental and neurocognitive factors than by heritability.
Functional Neurological Symptom Disorder (FNSD), also known as Conversion Disorder (CD), is characterized by neurological symptoms that cannot be explained by an identifiable neurological disease. These symptoms may include motor dysfunction (weakness, tremor, gait abnormalities), non-epileptic seizures, sensory disturbances, or mixed presentations. Although symptoms are not attributable to structural neurological pathology, they cause significant functional impairment.
The etiology of FNSD remains unclear. Proposed mechanisms include altered functional connectivity between emotional processing networks and motor/sensory regions, impaired memory and attention processing, and stress-related neurobiological dysregulation. Neurocognitive models suggest that attention and memory impairments may be present in individuals with FNSD, particularly under stress.
Despite increasing research on SCT/CDS in ADHD and other psychiatric conditions, SCT/CDS symptoms have not been systematically studied in adults with FNSD. Considering the hypothesized cognitive and attentional involvement in FNSD, SCT/CDS symptoms may be present in this population.
This study is designed as a cross-sectional case-control study conducted at the Psychiatry Outpatient Clinic of Elazığ Mental Health and Diseases Hospital. Participants will include adults aged 18-65 years diagnosed with FNSD according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision criteria and a matched healthy control group without psychiatric diagnoses.
Participants will complete a sociodemographic and clinical information form and validated psychometric scales, including: Barkley's Adult Sluggish Cognitive Tempo Scale (Turkish version), Somatoform Dissociation Questionnaire, Adult ADHD Self-Report Scale. No invasive or interventional procedures will be performed. Group comparisons will be conducted using appropriate parametric or non-parametric tests. Correlation and regression analyses will be performed when necessary. Statistical significance will be defined as p ≤ 0.05. Power analysis indicates that a minimum of 24 participants per group (total n=48) is required to achieve 80% power at alpha=0.05.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mehmet Hamdi ÖRÜM, MD, Assoc Prof, Psychiatrist
- Phone Number: +905382207558
- Email: mhorum@hotmail.com
Study Locations
-
-
Elâzığ
-
Elâzığ, Elâzığ, Turkey (Türkiye), 23200
- Recruiting
- Elazığ Mental Health and Diseases Hospital
-
Contact:
- Mehmet Hamdi ÖRÜM MHÖ Assoc. Prof., Assoc. Prof.
- Phone Number: +905382207558
- Email: mhorum@hotmail.com
-
Elâzığ, Elâzığ, Turkey (Türkiye), 23200
- Not yet recruiting
- Elazığ Mental Health and Diseases Hospital Psychiatry Clinic
-
Contact:
- Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist
- Phone Number: +905382207558
- Email: mhorum@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria for the Functional Neurological Symptom Disorder (FNSD) Group:
- Meeting the diagnostic criteria for FNSD/CD according to DSM-5-TR at the time of admission
- Being between 18-65 years of age
- Absence of additional psychiatric disorders
- Absence of alcohol/substance use disorder
- Absence of neurological disorders affecting cognition
- Being in remission with FNSD/CD
- Completing sociodemographic data fully
- Willingness to complete the forms and scales.
- Willingness to participate in the study
Exclusion Criteria for the FNSD Group:
- Being under 18 or over 65 years of age
- Not meeting the diagnostic criteria for FNSD/CD according to DSM-5-TR
- Active alcohol/substance use
- Having neurological diseases affecting cognitive functions (such as Alzheimer's disease, delirium, Parkinson's disease)
- Not being willing to participate in the study
- Incomplete sociodemographic data
- Not being willing to complete forms and scales.
Inclusion Criteria for the Healthy Control (HC) Group
- Being between 18-65 years of age
- Not having any psychiatric disorder
- Not having an alcohol/substance use disorder
- Not having a neurological disorder affecting cognition
- Completing sociodemographic data in full
- Being willing to complete the forms and scales.
- Being willing to participate in the study
Exclusion Criteria for the HC Group:
- Being under 18 or over 65 years of age
- Having a psychiatric disorder
- Active alcohol/substance use
- Having neurological diseases affecting cognitive functions (such as Alzheimer's disease, delirium, Parkinson's disease)
- Not being willing to participate in the study
- Incomplete sociodemographic data
- Not being willing to complete forms and scales.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Functional Neurological Symptom Disorder (FNSD)
Adult participants (18-65 years) with Functional Neurological Symptom Disorder (FNSD) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision criteria.
Participants will be evaluated at baseline.
No intervention will be assigned by the study protocol.
Clinical assessments in the FNSD group will include the Barkley's Adult Sluggish Cognitive Tempo Ratings Scale -Turkish Version, Somatoform Dissociation Questionnaire, Adult Attention-Deficit/Hyperactivity Disorder Self-Report Scale.
Sociodemographic and clinical data will be recorded for all participants.
|
|
Healthy Control (HC)
Healthy control (HC) adult participants (18-65 years) without any current or past psychiatric disorder will be enrolled in the study.
No intervention will be administered as part of the research protocol.
Participants will undergo a baseline clinical evaluation.
Clinical assessments in the HC group will include the Barkley's Adult Sluggish Cognitive Tempo Ratings Scale -Turkish Version, Somatoform Dissociation Questionnaire, Adult Attention-Deficit/Hyperactivity Disorder Self-Report Scale.
Sociodemographic and clinical data will be recorded for all participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barkley's Adult Sluggish Cognitive Tempo Ratings Scale -Turkish Version (SCT)
Time Frame: At hospital admission (baseline)
|
Adult Sluggish Cognitive Tempo Ratings Scale (SCT) was developed by choosing the symptom sets used in prior studies of SCT in children and adolescents.
It is a self-report scale and included the following nine items: "1.
Prone to daydreaming when I should be concen trating"; "2.
I have trouble staying alert or awake in boring situations"; "3.
I am easily confused"; "4.
I am easily bored"; "5.
My mind is spacey or in a fog"; "6.
I am lethargic, more tired than others"; "7.
I am underactive or have less energy than others"; "8.
I am a slow- moving"; "9.
I don't seem to process information as quickly or as accurately as others.".Barkley suggested using the number of SCT symptoms answered often or very often as a total score and 5 or higher total score as a cutoff point for having elevated SCT.
|
At hospital admission (baseline)
|
|
Somatoform Dissociation Questionnaire (SDQ-20)
Time Frame: At hospital admission (baseline)
|
The Somatoform Dissociation Questionnaire is a self-assessment scale which is administered to psychiatric patients, individuals with traumatic experiences, and non-clinical populations for screening purposes.
The self-administered scale contains 20 questions, each answered with a scale of 1 to 5 options.
Studies in Turkey have reported that individuals with a total score of 40 or higher have a high probability of having a dissociative disorder.
|
At hospital admission (baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adult ADHD Self-Report Scale (ASRS)
Time Frame: At hospital admission (baseline)
|
The Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Self-Report Scale is a 5-point Likert-type scale (0-4 = never, rarely, sometimes, often, very often) to identify current ADHD symptoms.
The scale consists 18 items: nine for attention deficit (Items 1,2,3,4,7,8,9,10,11) and nine for hyperactivity/impulsivity (Items 5,6,12,13,14,15,16,17,18). Stepwise regression analysis demonstrated that 6 items of the scale could predict the diagnosis of ADHD better, and these 6 items were listed under section A. Higher scores are associated with higher ADHD severity.
|
At hospital admission (baseline)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMHDH-2026-FNSD-SLUGGISHTEMPO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.