ClinicalTrials.gg
CompletedNCT06022393Updated Sep 29, 2025

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

An interventional study of Cognitive Reappraisal and Reflection in Functional Movement Disorder, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Medical University of Graz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Functional Movement Disorder

Keywords

  • EEG
  • Psychology
  • neuropsychology
  • cognitive reappraisal
  • cognitive behavioral therapy
  • Emotional Regulation
03

In context

Conversion Disorder

89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.

This study's enrollment of 20 is below the median of 38 across 51 interventional studies indexed under Conversion Disorder.

Browse Conversion Disorder studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Diagnosis of a functional movement disorder

Exclusion criteria

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Cognitive Reappraisal

    The intervention group completes CBT-training to improve their cognitive reappraisal and emotion-regulation-skills.

    Behavioral: Cognitive Reappraisal

  • Sham comparator
    Reflection

    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

Interventions

  • BehavioralCognitive 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.

  • BehavioralReflection

    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.

06

What researchers measure

Primary outcomes

  1. 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: 1. Not at all/very easy 2. Lightly 3. Moderate 4. Strong 5. Very strong Higher values = worse outcome

    Time frame: 4 weeks

  2. 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

    Time frame: 4 weeks

  3. 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: 1. Not at all/very easy 2. Lightly 3. Moderate 4. Strong 5. Very strong Higher values = worse outcome

    Time frame: 4 weeks

  4. 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

    Time frame: 4 weeks

  5. 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.

    Time frame: 4 weeks

  6. 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.

    Time frame: 4 weeks

Secondary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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.

    Time frame: 4 weeks

  3. Change in the patients Creativity

    The change in creativity assessed using the Verbal Creativity Test. No Minimum or Maximum values, higher score = better outcome.

    Time frame: 4 weeks

  4. 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.

    Time frame: 4 weeks

  5. 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.

    Time frame: 4 weeks

  6. 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.

    Time frame: 4 weeks

  7. 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

    Time frame: 4 weeks

  8. 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

    Time frame: 8 weeks

  9. 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: 1. Not at all/very easy 2. Lightly 3. Moderate 4. Strong 5. Very strong Higher values = worse outcome

    Time frame: 8 weeks

07

Study locations

1 site
  • Medical University of graz
    Graz, Styria 8010, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06022393
Collaborators
University of Graz
Responsible party
Sponsor
First posted
Sep 1, 2023
Start date
Aug 16, 2023
Primary completion
Feb 28, 2024
Completion
Aug 31, 2025
Last update
Sep 29, 2025

Study contacts

Corinna Perchtold-Stefan, PhD
study chair · University of Graz
Petra Schwingenschuh, MD
study chair · Medical University of Graz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion