- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06771375
Eye Movement Desensitization and Reprocessing (EMDR) to Treat Chronic Pruritus
January 7, 2025 updated by: University Hospital, Basel, Switzerland
Eye Movement Desensitization and Reprocessing (EMDR) to Treat Chronic Pruritus in a Multidisciplinary Tertiary Care Setting- a Feasibility Study
Pruritus is a common symptom of numerous dermatological and non-dermatological conditions.
Current treatments for chronic pruritus (CP) are often not fully effective and may have burdensome side effects.
Recently, the trauma exposure technique Eye Movement Desensitization and Reprocessing (EMDR) that is recommended as first line treatment for posttraumatic stress disorder has been reported to be also effective in the treatment of CP in anecdotal clinical case observations.
However, to the best of the investigator's knowledge, the efficacy of EMDR in CP has not yet been systematically explored.
This study aims at addressing this unmet need in a prospective pilot study comparing EMDR versus treatment as usual (TAU).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chrysovalandis Schwale, Dr.
- Phone Number: +41 61 265 52 94
- Email: chrysovalandis.schwale@usb.ch
Study Contact Backup
- Name: Rainer Schaefert, Prof.
- Phone Number: +41 61 265 52 94
- Email: rainer.schaefert@usb.ch
Study Locations
-
-
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Basel, Switzerland, 4031
- University Hospital Basel
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Contact:
- Chrysovalandis Schwale, Dr. med.
- Phone Number: +41 61 265 52 94
- Email: chrysovalandis.schwale@usb.ch
-
Contact:
- Rainer Schäfert, Prof. Dr.
- Phone Number: +41 61 265 52 94
- Email: rainer.schaefert@usb.ch
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Provided written informed consent
- Age 18 to 75 years
- Skindex-29 (questionnaire) symptoms subscale ≥42
- Confirmed diagnosis CP
- Itch intensity of min. ≥ 4 on the 0-10 numerical rating scale within the last 7 days
- Stable course of treatment in the two weeks prior to the study
Exclusion Criteria:
- Inability to follow the procedures of the study, e.g. due to language problems, severe psychiatric disorders such as delusional disorder, suicidality or dementia.
- Patients on phototherapy
- Acute attacks of an autoimmune disease such as Crohn's disease
- Serious cardiac disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
EMDR (Eye Movement Desensitization and Reprocessing)-Treatment of patients suffering from CP + Treatment as Usual (TAU).
|
EMDR is a psychotherapeutic approach originally designed for individuals suffering from trauma and post-traumatic stress disorder (PTSD).
It facilitates the processing of memories through a structured eight-phase treatment, involving the patient's focused attention on traumatic images, thoughts, and sensations while simultaneously engaging in bilateral stimulation, typically through guided eye movements.
This process aims to reduce the emotional distress associated with aversive memories, promoting adaptive coping mechanisms and psychological healing.
Recently, the indications for the method have been extended so that EMDR is also used for chronic pain and depressive disorders.
|
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No Intervention: Standard of care group
Treatment as Usual (TAU) - depending on the underlying disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence (%)
Time Frame: up to 8 month
|
Adherence/ receipt of intervention and retention will be assessed by tracking % of sessions completed, number of dropouts and number of patients completing final assessment.
|
up to 8 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chrysovalandis Schwale, Dr., University Hospital, Basel, Switzerland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
January 7, 2025
First Submitted That Met QC Criteria
January 7, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 7, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-02597, th24schaefert
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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