- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05941559
EMDR for Persistent Pain in RA
Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) Therapy in Rheumatoid Arthritis (RA) Patients With Persistent Pain Despite Inflammation Being Under Control: a Multiple Baseline Single Case Experimental Design Study Across Ten Cases
Rationale: Around 20% of rheumatoid arthritis (RA) patients have persistent pain, despite having well-controlled disease activity. There is a significant overlap in underlying mechanisms between post-traumatic stress disorder (PTSD) and persistent pain. Eye Movement Desensitization and Reprocessing (EMDR) is a proven effective treatment for PTSD and evidence is growing that it may also be effective for persistent pain. Objective: To assess the feasibility and estimate the effectiveness of EMDR in RA patients with persistent pain despite inflammation being under control.
Study design: A multiple-baseline single-case experimental design (SCED) across three time series. Participants will be randomized to one of the three time series. Within the time series the start of the intervention is randomly determined. Four participants will be assigned to the shortest, three to the medium and three to the longest baseline length. The SCED study consists of a baseline phase (A1), intervention phase (B), post-treatment phase (A2), follow-up phase 1 (A3), and follow-up phase 2 (A4).
Study population: Subjects are RA patients > 18 years with low disease activity (DAS28<3.2) at >2 measurements over the previous 12 months and concurrent elevated pain scores (NRS-pain>6).
Intervention (if applicable): EMDR therapy consists of an intake and eight sessions of 90 minutes in total, performed according to the EMDR standard protocol, conducted by four psychologists, all are level-II trained, under the supervision of an EMDR Europe consultant. EMDR focuses on processing traumatic memories, pain-related memories, and current physical pain.
Main study parameters/endpoints: Primary endpoint for effectiveness is the pre-treatment phase A1 to post-treatment phase A2 difference in NRS pain intensity. Feasibility is examined by monitoring recruitment, dropout rates, and treatment satisfaction. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: If the therapy is effective, pain intensity decreases, additional physical complaints of RA decrease and participants experience less discomfort from their pain in daily life. EMDR therapy is an evidence-based treatment for PTSD and the reduction of posttraumatic stress favors the recovery of physical complaints. Participating in the study includes two conversations for inclusion (two times 60 minutes consisting of one telephone conversation and one face-to-face conversation), attending the EMDR therapy intake (one time 90 minutes) and sessions (eight times 90 minutes), and daily registration of complaints (about two minutes per day) via a smartphone application, completing the questionnaires (about 14-28 minutes at six specific time points during the study), and an exit conversation at six months follow up. Daily registration will take 18 to 20 weeks maximum. At the three- and six-month follow-up, participants will be asked to register daily for 14 days. EMDR sessions can be emotionally intense, but never are as challenging as living with unprocessed (traumatic) pain-related memories. There are no risks associated with EMDR therapy.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Harald Vonkeman, MD
- Phone Number: +31534872450
- Email: h.vonkeman@mst.nl
Study Contact Backup
- Name: Anne Schuurman-Kuipers, MSc
- Phone Number: +31534755755
- Email: a.schuurman@mediant.nl
Study Locations
-
-
Overijssel
-
Enschede, Overijssel, Netherlands, 7512KZ
- Medisch Spectrum Twente
-
Contact:
- Mirjam Hegeman
- Phone Number: +31534872450
- Email: m.hegeman@mst.nl
-
Contact:
- Anne Schuurman-Kuipers
- Phone Number: +31534755755
- Email: a.schuurman@mediant.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinical diagnosis of RA
- Stable low disease activity Score in 28 joints, i.e. DAS28 <3.2 at >2 measurements over the previous 12 months and at the time of inclusion
- Elevated pain scores (NRS pain >6) at >2 measurements over the previous 12 months and at the time of inclusion
- Sufficient knowledge of the Dutch language
Exclusion Criteria:
- An acute condition of psychosis or bipolar disorder
- An acute suicidal risk
- Substance dependency
- Not stable on the use of medication
- Visual or hearing problems interfering with the EMDR procedure
- Other psychological/psychiatric treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Shortest baseline length
Intervention starting points are at day 15, 16, 17, 18 or 19.
|
Eye Movement Desensitization and Reprocessing
|
Other: Medium baseline length
Intervention starting points are at day 20, 21, 22, 23, and 24.
|
Eye Movement Desensitization and Reprocessing
|
Other: Longest baseline length
Intervention starting points are at day 25, 26, 27, 28, or 29.
|
Eye Movement Desensitization and Reprocessing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness
Time Frame: 100 Days
|
Difference in NRS pain intensity
|
100 Days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMDR in RA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
Clinical Trials on EMDR
-
Erasmus Medical CenterNot yet recruitingAnxiety and Fear
-
University of PisaCompletedObsessive-Compulsive Disorder | Post-traumatic Stress Disorder | Guilt | Adult ALL | Shame | DisgustItaly
-
University Hospital, ToursInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedDepression | Burnout, Professional | Post Traumatic Stress DisorderFrance
-
Ciclo de MutaçãoSao Jose do Rio Preto Medical SchoolCompleted
-
ArkinAmsterdam UMC, location VUmc; Ziekenhuis Amstelland; Meander Medisch Centrum; Sinai... and other collaboratorsRecruitingPosttraumatic Stress Disorder (PTSD) | Borderline Personality Disorder (BPD)Netherlands
-
University of PisaCompletedCognitive Change | Child, Only | Distress, Emotional | Narration | Memory DysfunctionItaly
-
Mersin UniversityRecruiting
-
Centre Hospitalier Régional Metz-ThionvilleUniversity of LorraineCompletedBreast Cancer | Eye Movement Desensitization and Processing | PsychoterapyFrance
-
Trauma Institute & Child Trauma InstituteUnknownTrauma, Psychological | Motor Vehicle AccidentUnited States