CBT Training for Cognitive Reappraisal as an Intervention for Patients With Functional Tremor - an EEG Study

Study Overview
=================
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.

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: CGI-S - Clinical Global Impression - severity PGI-S - Patient Global Impression - severity FTM - Fahn Tolosa Marin Tremor Rating Scale S-FMDRS - Simplified Version of the Psychogenic Movement Disorders Rating Scale Questionnaires completed during the first EEG-lab-session: VKT - Verbal creativity test RIT - Reappraisal Inventiveness Test ERQ - Emotion Regulation Questionnaire LPFS-BF - Level of Personality Functioning Scale: SF-36 - Short Form (36) EQ-5D-5L - Health Questionnaire PAHD - Psychosomatic Assessment Health-DISC Questionnaires completed during the second preliminary examination: All the questionnaires also used in the first examination plus: CGI-C - Clinical Global Impression - Change 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.

Official Title
-----------------
CBT-Training Zur Kognitiven Umbewertung Als Lntervention Bei Patienten*Innen Mit Funktionellem Tremor - Eine EEG-Studie

Conditions
-----------------
Functional Movement Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive Reappraisal
* Behavioral: Reflection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Diagnosis of a functional movement disorder Exclusion Criteria: The patient is not capable of giving consent. The patient does not have sufficient knowledge of German to answer the questionnaires (questionnaires are only available in German).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients are randomly assigned to one of two groups. The intervention group completes CBT-training to improve their cognitive reappraisal and consequently their emotion-regulation-skills and the control group completes tasks that ask them to reflect about their daily lifes.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Reappraisal<br>The intervention group completes CBT-training to improve their cognitive reappraisal and emotion-regulation-skills. | Behavioral: Cognitive Reappraisal<br>* Patients complete 14 tasks on an app in a time span of 4 weeks in which they are asked to cognitively reappraise fear or anger inducing situations and are encouraged to implement this strategy into their daily lifes.<br>|
| Sham Comparator: Reflection<br>The control group completes tasks based on reflection about their daily lifes, which should have no impact on their emotion-regulation-skills or functional motor disorder. | Behavioral: Reflection<br>* Patients complete 14 tasks on an app in a time span of 4 weeks in which they are asked to reflect on certain topics of their day.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical health - Clinical Global Impression Severity Scale | Clinical health according to Clinical Global Impression of Severity Scale (CGI-S) rated by a medical professional. Three questions regarding patients current mood, influence of the symptoms on everyday motor function and overall severity. Answer options: Not at all/very easy Lightly Moderate Strong Very strong Higher values = worse outcome | 4 weeks | 
| Change in Clinical health - Clinical Global Impression of Change | Clinical health according to Clinical Global Impression of Change Scale (CGI-C) rated by a medical professional. Three questions regarding patients mood, everyday motor function and overall change as well as a rating regarding the relevance of the change (Yes or No). Answer options: Very Much worse Much worse Slightly worse No change Marginally better Much better Very Much better Higher values = better outcome | 4 weeks | 
| Change in Self-assessed health - Patient Global Impression Severity Scale | Self-assessed health according to Patient Global Impression of Severity Scale (PGI-S) rated by the patients themselves. Three questions regarding patients current mood, influence of the symptoms on everyday bodily function and overall severity. Answer options: Not at all/very easy Lightly Moderate Strong Very strong Higher values = worse outcome | 4 weeks | 
| Change in Self-assessed health - Patient Global Impression of Change | Self-assessed health according to Patient Gloabal Impression of Change Scale (PGI-C) rated by the patients themselves. Three questions regarding patients mood, everyday bodily function and overall change as well as a rating regarding the relevance of the change (Yes or No). Answer options: Very Much worse Much worse Slightly worse No change Marginally better Much better Very Much better Higher values = better outcome | 4 weeks | 
| The change in severity of the functional movement disorder | The change in severity as assessed by a blinded clinician using the severity of the functional movement disorder by means of the Simplified Version of the Psychogenic Movement Disorders Rating Scale (S-FMDRS). Scoring: 0-3, higher values indicate worse outcome. | 4 weeks | 
| The change in tremor severity | The change in tremor severity assessed using the Fahn Tolosa Marin Tremor-Rating-Scale. Scoring: 0-4, higher values indicate worse outcome. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the ability of emotion regulation | The change in the ability of emotion regulation assessed using the Emotion Regulation Questionnaire. High scores on the reassessment scale suggest that the person is more likely to use cognitive strategies to change the emotional meaning of situations. This may be associated with better emotional adaptability and well-being. High scores on the suppression scale indicate that the person is more inclined to suppress or avoid the expression of emotions. This may be associated with lower emotional adaptability and well-being. | 4 weeks | 
| Changes in patients EEG-activity. | Training-based changes in patients' EEG activity will be assessed for a) tasks-related changes in EEG alpha frequency power (TRPs) as well as b) frontal alpha asymmetry changes during the generation of cognitive reappraisals. Changes in these parameters should unterline behavioral changes in reappraisal success, divergent thinking, and executive functioning. Moreover, we will look at c) the EEG theta/beta frequency ratio to map changes in stress coping, emotion regulation, and behavioral flexibility. | 4 weeks | 
| Change in the patients Creativity | The change in creativity assessed using the Verbal Creativity Test. No Minimum or Maximum values, higher score = better outcome. | 4 weeks | 
| Change in the patients Welfare- Health Questionnaire EQ-5D-5L. | The change in the patients welfare assessed using the Health Questionnaire EQ-5D-5L. 5 Level, Scores: 1-5, higher values indicate worse outcome. 1 overall Scale: 0-100, higher values indicate better outcome. | 4 weeks | 
| Change in the patients Welfare- Short Form Health Questionnaire | The change in the patients welfare assessed using the Short Form Health Questionnaire. The possible score ranges from 0 to 100 points, with 0 points representing the greatest possible restriction of health, while 100 points indicate no health restriction. | 4 weeks | 
| Change in the patients Welfare - Psychosomatic Assessment Health-DISC. Minimum value in each section: 0 Maximum value in each section: 10 Higher scores = better outcome. | The change in the patients welfare assessed using the Psychosomatic Assessment Health-DISC 6 Levels, Scores: 0-10, higher values indicate better outcome. | 4 weeks | 
| Change in patients personality and behavioral aspects | The change in patients personality and behavioral aspects assessed using the Level of Personality Functioning Scale. The items are on a 4-point Likert scale from 1 (doesn't apply at all) to 4 (applies exactly) to). The evaluation is carried out by means of summaries, so that values on the Overall scale: 12 - 48 Subscales Self and Interpersonal: 6 - 24 | 4 weeks | 
| Long-term change in Self-assessed health - Patient Global Impression of Change | Self-assessed health according to Patient Global Impression of Change Scale (PGI-C) rated by the patients themselves. Three questions regarding patients mood, everyday bodily function and overall change as well as a rating regarding the relevance of the change (Yes or No). Answer options: Very Much worse Much worse Slightly worse No change Marginally better Much better Very Much better Higher values = better outcome | 8 weeks | 
| Long-term change in Self-assessed health - Patient Global Impression Severity Scale | Self-assessed health according to Patient Global Impression of Severity Scale (PGI-S) rated by the patients themselves. Three questions regarding patients current mood, influence of the symptoms on everyday bodily function and overall severity. Answer options: Not at all/very easy Lightly Moderate Strong Very strong Higher values = worse outcome | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EEG, Psychology, neuropsychology, cognitive reappraisal, cognitive behavioral therapy, Emotional Regulation