Eye Movement Desensitization and Reprocessing (EMDR) to Treat Chronic Pruritus

NCT06771375 | Not Yet Recruiting

• 1 other identifier: 2024-02597, th24schaefert
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Pruritus

Keywords

Eye Movement Desensitization and Reprocessing

Outcome Measures

Primary Outcomes (1)

• Adherence (%)

  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

Study Arms (2)

Intervention Group

EXPERIMENTAL

EMDR (Eye Movement Desensitization and Reprocessing)-Treatment of patients suffering from CP + Treatment as Usual (TAU).

Behavioral: Eye Movement Desensitization and Reprocessing

Standard of care group

NO INTERVENTION

Treatment as Usual (TAU) - depending on the underlying disease

Interventions

Eye Movement Desensitization and Reprocessing BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Eye Movement Desensitization Reprocessing

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Chrysovalandis Schwale, Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chrysovalandis Schwale, Dr.

CONTACT

+41 61 265 52 94; chrysovalandis.schwale@usb.ch

Rainer Schaefert, Prof.

CONTACT

+41 61 265 52 94; rainer.schaefert@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-randomized, open-label two-arm pre-post design feasibility-study

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)