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EMDR for Persistent Pain in RA

Primary Purpose

Rheumatoid Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
EMDR
Sponsored by
Medisch Spectrum Twente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Chronic pain, EMDR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medisch Spectrum Twente

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Shortest baseline length

Medium baseline length

Longest baseline length

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Effectiveness
Difference in NRS pain intensity

Secondary Outcome Measures

Full Information

First Posted
July 4, 2023
Last Updated
July 4, 2023
Sponsor
Medisch Spectrum Twente
Collaborators
University of Twente, Leiden University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05941559
Brief Title
EMDR for Persistent Pain in RA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medisch Spectrum Twente
Collaborators
University of Twente, Leiden University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Chronic pain, EMDR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shortest baseline length
Arm Type
Other
Arm Description
Intervention starting points are at day 15, 16, 17, 18 or 19.
Arm Title
Medium baseline length
Arm Type
Other
Arm Description
Intervention starting points are at day 20, 21, 22, 23, and 24.
Arm Title
Longest baseline length
Arm Type
Other
Arm Description
Intervention starting points are at day 25, 26, 27, 28, or 29.
Intervention Type
Other
Intervention Name(s)
EMDR
Intervention Description
Eye Movement Desensitization and Reprocessing
Primary Outcome Measure Information:
Title
Effectiveness
Description
Difference in NRS pain intensity
Time Frame
100 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harald Vonkeman, MD
Phone
+31534872450
Email
h.vonkeman@mst.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Schuurman-Kuipers, MSc
Phone
+31534755755
Email
a.schuurman@mediant.nl
Facility Information:
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Overijssel
ZIP/Postal Code
7512KZ
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Schuurman-Kuipers
Phone
+31534755755
Email
a.schuurman@mediant.nl
First Name & Middle Initial & Last Name & Degree
Mirjam Hegeman
Phone
+31534872450
Email
m.hegeman@mst.nl

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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EMDR for Persistent Pain in RA

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