Functional Movement DisorderNCT06022393

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

A study testing Cognitive Reappraisal and Reflection in people with Functional Movement Disorder, run by Medical University of Graz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Functional Movement Disorder
What is being tested?: Cognitive Reappraisal and Reflection
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteAustria
Study dates: 16 Aug 2023to 31 Aug 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of a functional movement disorder

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of graz
Graz, Styria, 8010

Other trials in Austria

About this study

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

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:

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.

Conditions: Functional Movement Disorder
Being tested: Cognitive Reappraisal, Reflection
Keywords: EEG, Psychology, neuropsychology, cognitive reappraisal, cognitive behavioral therapy, Emotional Regulation
Medical subject headings: Conversion Disorder, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive ReappraisalBehavioural
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.
ReflectionBehavioural
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.

Study groups in NCT06022393
Study group	Role	What they receive
Cognitive Reappraisal	Experimental	The intervention group completes CBT-training to improve their cognitive reappraisal and emotion-regulation-skills. Receives: Behavioral: Cognitive Reappraisal
Reflection	Sham comparator	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. Receives: Behavioral: Reflection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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:
1. Not at all/very easy
2. Lightly
3. Moderate
4. Strong
5. Very strong Higher values = worse outcome
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 202331 Aug 2025

First posted1 Sep 2023
Study start16 Aug 2023
Primary completion28 Feb 2024
Study completion31 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Functional Movement DisorderStudies of the same condition, open and under way.
More trials run by Medical University of GrazThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06022393
Sponsor's protocol ID: 35-315 ex 22/23
Status last verified: Sep 2023
First submitted: 17 Jul 2023
Last updated: 29 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CBT-Training Zur Kognitiven Umbewertung Als Lntervention Bei Patienten*Innen Mit Funktionellem Tremor - Eine EEG-Studie
ClinicalTrials.gov ID: NCT06022393
Acronym / sponsor ID: 35-315 ex 22/23
Conditions: Functional Movement Disorder
Keywords: EEG, Psychology, neuropsychology, cognitive reappraisal, cognitive behavioral therapy, Emotional Regulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Medical University of GrazUniversity, hospital or other
Collaborators: University of Graz
Study start: 16 Aug 2023 (actual)
Primary completion: 28 Feb 2024 (actual)
Study completion: 31 Aug 2025 (actual)
First posted: 1 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Cognitive Reappraisal	Experimental	Behavioral: Cognitive ReappraisalThe intervention group completes CBT-training to improve their cognitive reappraisal and emotion-regulation-skills.
Reflection	Sham comparator	Behavioral: ReflectionThe 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Diagnosis of a functional movement disorder

Key exclusion criteria (2 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive ReappraisalPatients 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.	Behavioural	Cognitive Reappraisal
ReflectionPatients 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.	Behavioural	Reflection

Primary outcome

Change in Clinical health - Clinical Global Impression Severity Scale
Time frame: 4 weeks
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
Change in Clinical health - Clinical Global Impression of Change
Time frame: 4 weeks
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
Change in Self-assessed health - Patient Global Impression Severity Scale
Time frame: 4 weeks
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
Change in Self-assessed health - Patient Global Impression of Change
Time frame: 4 weeks
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
The change in severity of the functional movement disorder
Time frame: 4 weeks
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.
The change in tremor severity
Time frame: 4 weeks
The change in tremor severity assessed using the Fahn Tolosa Marin Tremor-Rating-Scale. Scoring: 0-4, higher values indicate worse outcome.

9 secondary outcomes

Change in the ability of emotion regulation
Time frame: 4 weeks
Changes in patients EEG-activity.
Time frame: 4 weeks
Change in the patients Creativity
Time frame: 4 weeks
Change in the patients Welfare- Health Questionnaire EQ-5D-5L.
Time frame: 4 weeks
Change in the patients Welfare- Short Form Health Questionnaire
Time frame: 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.
Time frame: 4 weeks
Change in patients personality and behavioral aspects
Time frame: 4 weeks
Long-term change in Self-assessed health - Patient Global Impression of Change
Time frame: 8 weeks
Long-term change in Self-assessed health - Patient Global Impression Severity Scale
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Corinna Perchtold-Stefan, PhD study chair

University of Graz

Petra Schwingenschuh, MD study chair

Medical University of Graz

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Reappraisal and Reflection in people with Functional Movement Disorder, run by Medical University of Graz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Clinical health - Clinical Global Impression Severity Scale (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06022393.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.