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

Functional Movement Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06022393
• Other study ID #: 35-315 ex 22/23
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2023
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: Medical University of Graz
• Contact: Daniela Kern, MD
• Phone: 004331638516051
• Email: daniela.eibl[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Movement Disorder
• Movement Disorders

Intervention

Behavioral:
• Cognitive Reappraisal
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.
• Reflection
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.

Locations

Country	Name	City	State
Austria	Medical University of graz	Graz	Styria

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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