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

NCT06022393 | Completed

• 1 other identifier: 35-315 ex 22/23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Movement Disorder

Keywords

EEG; Psychology; neuropsychology; cognitive reappraisal; cognitive behavioral therapy; Emotional Regulation

Outcome Measures

Primary Outcomes (6)

• 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

  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: 1. Not at all/very easy 2. Lightly 3. Moderate 4. Strong 5. 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 Outcomes (9)

• Change in the ability of emotion regulation

  4 weeks

• Changes in patients EEG-activity.

  4 weeks

• Change in the patients Creativity

  4 weeks

• Change in the patients Welfare- Health Questionnaire EQ-5D-5L.

  4 weeks

• Change in the patients Welfare- Short Form Health Questionnaire

  4 weeks

Study Arms (2)

Cognitive Reappraisal

EXPERIMENTAL

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

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.

Behavioral: Reflection

Interventions

Cognitive Reappraisal BEHAVIORAL

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.

Cognitive Reappraisal

Reflection BEHAVIORAL

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.

Reflection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Diagnosis of a functional movement disorder

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Graz: lead
• University of Graz: collaborator

Study Sites (1)

Medical University of graz

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Conversion Disorder; Emotional Regulation

Interventions

Microscopy, Interference

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Interferometry; Investigative Techniques

Study Officials

• Corinna Perchtold-Stefan, PhD

  University of Graz

  STUDY CHAIR

• Petra Schwingenschuh, MD

  Medical University of Graz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients are randomly assigned to a group and do not know whether that is the intervention or the control group. The physicians conducting the preliminary assessments do not know which group the patient was placed in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: September 1, 2023
• Study Start: August 16, 2023
• Primary Completion: February 28, 2024
• Study Completion: August 31, 2025
• Last Updated: September 29, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)