Clinical trial NCT06022393: CBT Training for Cognitive Reappraisal as an Intervention for Patients With Functional Tremor - an EEG Study
Official title: CBT-Training Zur Kognitiven Umbewertung Als Lntervention Bei Patienten*Innen Mit Funktionellem Tremor - Eine EEG-Studie
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Movement Disorder
Keywords: EEG
Psychology
neuropsychology
cognitive reappraisal
cognitive behavioral therapy
Emotional Regulation
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: University of Graz
First posted: 2023-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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:

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.

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).

Primary outcomes:
measure: Change in Clinical health - Clinical Global Impression Severity Scale
timeFrame: 4 weeks
measure: Change in Clinical health - Clinical Global Impression of Change
timeFrame: 4 weeks
measure: Change in Self-assessed health - Patient Global Impression Severity Scale
timeFrame: 4 weeks
measure: Change in Self-assessed health - Patient Global Impression of Change
timeFrame: 4 weeks
measure: The change in severity of the functional movement disorder
timeFrame: 4 weeks
measure: The change in tremor severity
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in the ability of emotion regulation
timeFrame: 4 weeks
measure: Changes in patients EEG-activity.
timeFrame: 4 weeks
measure: Change in the patients Creativity
timeFrame: 4 weeks
measure: Change in the patients Welfare- Health Questionnaire EQ-5D-5L.
timeFrame: 4 weeks
measure: Change in the patients Welfare- Short Form Health Questionnaire
timeFrame: 4 weeks
measure: 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.
timeFrame: 4 weeks
measure: Change in patients personality and behavioral aspects
timeFrame: 4 weeks
measure: Long-term change in Self-assessed health - Patient Global Impression of Change
timeFrame: 8 weeks
measure: Long-term change in Self-assessed health - Patient Global Impression Severity Scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of graz
state: Styria
Study officials:
affiliation: University of Graz
name: Corinna Perchtold-Stefan, PhD
role: STUDY_CHAIR
affiliation: Medical University of Graz
name: Petra Schwingenschuh, MD
role: STUDY_CHAIR
References: