EMDR for Persistent Pain in RA

NCT05941559 | Enrolling By Invitation

• 1 other identifier: EMDR in RA
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

Chronic pain; EMDR

Outcome Measures

Primary Outcomes (1)

• Effectiveness

  Difference in Numeric Rating Scale (NRS) pain intensity. Scale 0-6, 0 means never (good outcome), 6 means always (bad outcome)

  100 Days

Study Arms (3)

Shortest baseline length

OTHER

Intervention starting points are at day 15, 16, 17, 18 or 19.

Other: EMDR

Medium baseline length

OTHER

Intervention starting points are at day 20, 21, 22, 23, and 24.

Other: EMDR

Longest baseline length

OTHER

Intervention starting points are at day 25, 26, 27, 28, or 29.

Other: EMDR

Interventions

EMDR OTHER

Eye Movement Desensitization and Reprocessing

Longest baseline length; Medium baseline length; Shortest baseline length

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of RA
• Sufficient knowledge of the Dutch language

You may not qualify if:

• 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

Sponsors & Collaborators

• Medisch Spectrum Twente: lead
• University of Twente: collaborator
• Leiden University Medical Center: collaborator

Study Sites (1)

Medisch Spectrum Twente

Enschede, Overijssel, 7512KZ, Netherlands

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Chronic Pain

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr.

Model Details: 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 Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: August 22, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

NL (1)