Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 5:47 AM
Study NCT ID:
NCT06022393
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2023-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CBT Training for Cognitive Reappraisal as an Intervention for Patients With Functional Tremor - an EEG Study
Sponsor:
Medical University of Graz
Organization:
Study Overview
Official Title:
CBT-Training Zur Kognitiven Umbewertung Als Lntervention Bei Patienten*Innen Mit Funktionellem Tremor - Eine EEG-Studie
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this psychological study is to evaluate the effect of a cognitive behavioral therapy (CBT) intervention aimed at improving cognitive reappraisal on (1) Clinical and Self-Rated Health according to Patient Global Impression-Change (PGI-C), Patient Global Impression-Severity (PGI-S), Clinical Global Impression-Change (CGI-C) and Clinical Global Impression-Severity (CGI-S) after 4 weeks, (2) the change in the severity of the functional movement disorder/tremor as assessed by a blinded clinician using the Simplified Version of the Psychogenic Movement Disorders Rating Scale (S-FMDRS) after 4 weeks and (3) the change in the severity of functional tremor assessed via the Fahn Tolosa Marin Tremor Rating Scale (FTM) after 4 weeks.
The knowledge gained about the introspective and neurobiological effect of this cognitive behavioral therapy intervention should enable improved therapy options for patients with functional tremor / functional motor disorders in the future.
The knowledge gained about the introspective and neurobiological effect of this cognitive behavioral therapy intervention should enable improved therapy options for patients with functional tremor / functional motor disorders in the future.
Detailed Description:
This is an intervention study including patients of the outpatient clinic for movement disorders at the University Clinic of Neurology in Graz.
The patients will randomly be assigned to the intervention (cognitive reappraisal) or control (reflection) group.
The study consists of a first preliminary examination at the University clinic, followed by an electroencephalogram (EEG)-lab-session at the Institute of Psychology of the Karl-Franzens-University of Graz. The patients will complete emotion-regulation tasks while the EEG is conducted and then be introduced to an App, with which they will either complete 14 cognitive-reappraisal-tasks (intervention) or 14 reflection-tasks (control) within the next 4 weeks. A task will need to be completed in the App once every two days.
After this training period, there will be a second preliminary examination at the University Clinic as well as a second subsequent EEG-lab-sessions at the Institute of Psychology at the Karl-Franzens-University.
In addition, after two weeks of training, the patients will receive a short phone call and will be asked to complete the PGI-S and PGI-C.
Questionnaires completed during the first preliminary examination:
1. CGI-S - Clinical Global Impression - severity
2. PGI-S - Patient Global Impression - severity
3. FTM - Fahn Tolosa Marin Tremor Rating Scale
4. S-FMDRS - Simplified Version of the Psychogenic Movement Disorders Rating Scale
Questionnaires completed during the first EEG-lab-session:
1. VKT - Verbal creativity test
2. RIT - Reappraisal Inventiveness Test
3. ERQ - Emotion Regulation Questionnaire
4. LPFS-BF - Level of Personality Functioning Scale:
5. SF-36 - Short Form (36)
6. EQ-5D-5L - Health Questionnaire
7. PAHD - Psychosomatic Assessment Health-DISC
Questionnaires completed during the second preliminary examination:
All the questionnaires also used in the first examination plus:
1. CGI-C - Clinical Global Impression - Change
2. PGI-C - Patient Global Impression - Change
Questionnaires completed during the second EEG-lab-session:
The same as in the first EEG-lab-session.
4 weeks after the completion of the last EEG-lab-session, the patients will receive another short phone-call in which they will again be asked to complete the PGI-S and PGI-C.
The patients will randomly be assigned to the intervention (cognitive reappraisal) or control (reflection) group.
The study consists of a first preliminary examination at the University clinic, followed by an electroencephalogram (EEG)-lab-session at the Institute of Psychology of the Karl-Franzens-University of Graz. The patients will complete emotion-regulation tasks while the EEG is conducted and then be introduced to an App, with which they will either complete 14 cognitive-reappraisal-tasks (intervention) or 14 reflection-tasks (control) within the next 4 weeks. A task will need to be completed in the App once every two days.
After this training period, there will be a second preliminary examination at the University Clinic as well as a second subsequent EEG-lab-sessions at the Institute of Psychology at the Karl-Franzens-University.
In addition, after two weeks of training, the patients will receive a short phone call and will be asked to complete the PGI-S and PGI-C.
Questionnaires completed during the first preliminary examination:
1. CGI-S - Clinical Global Impression - severity
2. PGI-S - Patient Global Impression - severity
3. FTM - Fahn Tolosa Marin Tremor Rating Scale
4. S-FMDRS - Simplified Version of the Psychogenic Movement Disorders Rating Scale
Questionnaires completed during the first EEG-lab-session:
1. VKT - Verbal creativity test
2. RIT - Reappraisal Inventiveness Test
3. ERQ - Emotion Regulation Questionnaire
4. LPFS-BF - Level of Personality Functioning Scale:
5. SF-36 - Short Form (36)
6. EQ-5D-5L - Health Questionnaire
7. PAHD - Psychosomatic Assessment Health-DISC
Questionnaires completed during the second preliminary examination:
All the questionnaires also used in the first examination plus:
1. CGI-C - Clinical Global Impression - Change
2. PGI-C - Patient Global Impression - Change
Questionnaires completed during the second EEG-lab-session:
The same as in the first EEG-lab-session.
4 weeks after the completion of the last EEG-lab-session, the patients will receive another short phone-call in which they will again be asked to complete the PGI-S and PGI-C.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: