To assess the effectiveness of EMDR in RA patients with persistent pain despite inflammation being under control.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Secondary parameters are:
* Additional physical symptoms (stiffness in muscles and joints and fatigue)
(DQ-PiRA)
* The impact of RA on daily life and sleep (DQ-PiRA)
* Four PTSD symptoms will be measured with the 4itemPCL-5
* The score on the Generalized Pain Questionnaire (GPQ)
* The score on the Pain Disability Index (PDI)
* The score on the Rheumatoid Arthritis Pain Scale (RAPS)
* The total score on Beck*s depression index (BDI)
Background summary
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.
Study objective
To assess 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).
Intervention
EMDR therapy consists of an intake session and treatment sessions of 90
minutes, 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.
Study burden and risks
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 (on average approximately 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.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
Clinical diagnosis RA
NRS pain >= 5 at screening and NRS-pain >=4 at the time of inclusion
Stable low disease activity (DAS28 < 3.2) and/or the rheumatologist's clinical
impression of low disease activity
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
Involved in other psychological/psychiatric treatment
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05941559 |
| CCMO | NL84912.100.23 |