Rheumatoid ArthritisNCT05941559
EMDR for Persistent Pain in RA
A study testing EMDR in people with Rheumatoid Arthritis, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- EMDR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Aug 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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).
Read more
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
- Being tested
- EMDR
- Keywords
- Chronic pain, EMDR
- Medical subject headings
- Arthritis, Rheumatoid, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDROther
Eye Movement Desensitization and Reprocessing
| Study group | Role | What they receive |
|---|---|---|
| Shortest baseline length | Other | Intervention starting points are at day 15, 16, 17, 18 or 19. Receives: Other: EMDR |
| Medium baseline length | Other | Intervention starting points are at day 20, 21, 22, 23, and 24. Receives: Other: EMDR |
| Longest baseline length | Other | Intervention starting points are at day 25, 26, 27, 28, or 29. Receives: Other: EMDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Difference in Numeric Rating Scale (NRS) pain intensity. Scale 0-6, 0 means never (good outcome), 6 means always (bad outcome)
Measured: 100 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start22 Aug 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente, Leiden University Medical Center
- Responsible party
- Principal investigator, Harald E. Vonkeman, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941559
- Sponsor's protocol ID
- EMDR in RA
- Status last verified
- Nov 2024
- First submitted
- 4 Jul 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05941559
- Acronym / sponsor ID
- EMDR in RA
- Conditions
- Rheumatoid Arthritis
- Keywords
- Chronic pain, EMDR
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Collaborators
- University of Twente, Leiden University Medical Center
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Shortest baseline length | Other | Other: EMDRIntervention starting points are at day 15, 16, 17, 18 or 19. |
| Medium baseline length | Other | Other: EMDRIntervention starting points are at day 20, 21, 22, 23, and 24. |
| Longest baseline length | Other | Other: EMDRIntervention starting points are at day 25, 26, 27, 28, or 29. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDREye Movement Desensitization and Reprocessing | Other | Longest baseline length, Medium baseline length, Shortest baseline length |
Primary outcome
Effectiveness
Time frame: 100 Days
Difference in Numeric Rating Scale (NRS) pain intensity. Scale 0-6, 0 means never (good outcome), 6 means always (bad outcome)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR in people with Rheumatoid Arthritis, run by Medisch Spectrum Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: 100 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.