Trauma-focused EMDR for Personality disorders among Outpatients (TEMPO): study protocol for a multi-centre, single-blind, randomized controlled trial

Simon Hofman, Laurian Hafkemeijer, Ad de Jongh, Annemieke Starrenburg, Karin Slotema*

*Corresponding author for this work

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

Background: Existing recommended treatment options for personality disorders (PDs) are extensive and costly. There is emerging evidence indicating that trauma-focused treatment using eye movement desensitization and reprocessing (EMDR) therapy aimed at resolving memories of individuals’ adverse events can be beneficial for this target group within a relatively short time frame. The primary purpose of the present study is to determine the effectiveness of EMDR therapy versus waiting list in reducing PD symptom severity. Furthermore, the effects of EMDR therapy on trauma symptom severity, loss of diagnosis, personal functioning, quality of life, and mental health outcomes will be determined. In addition, the cost-effectiveness of EMDR therapy in the treatment of PDs is investigated. Moreover, predictors of treatment success, symptom deterioration and treatment discontinuation will be assessed. Lastly, experiences with EMDR therapy will be explored. Method: In total, 159 patients with a PD will be included in a large multicentre single-blind randomized controlled trial. The Structured Clinical Interview for DSM-5 Personality Disorders will be used to determine the presence of a PD. Participants will be allocated to either a treatment condition with EMDR therapy (ten biweekly 90-min sessions) or a waiting list. Three months after potential treatment with EMDR therapy, patients can receive treatment as usual for their PD. All participants are subject to single-blinded baseline, post-intervention and 3-, 6- and 12-month follow-up assessments. The primary outcome measures are the Assessment of DSM-IV Personality Disorders and the Clinician-Administered PTSD Scale for DSM-5. For cost-effectiveness, the Treatment Inventory of Costs in Patients with psychiatric disorders, EuroQol-5D-3L, and the Mental Health Quality of Life Questionnaire will be administered. The PTSD Checklist for DSM-5, Brief State Paranoia Checklist and Difficulties in Emotion Regulation Scale will be used to further index trauma symptom severity. Type of trauma is identified at baseline with the Childhood Trauma Questionnaire-SF and Life Events Checklist for the DSM-5. Personal functioning and health outcome are assessed with the Level of Personality Functioning Scale-BF 2.0, Outcome Questionnaire-45 and Mental Health Quality of Life Questionnaire. Experiences with EMDR therapy of patients in the EMDR therapy condition are explored with a semi-structured interview at post-intervention. Discussion: It is expected that the results of this study will contribute to knowledge about the effectiveness, and cost-effectiveness of trauma-focused treatment using EMDR therapy in individuals diagnosed with a PD. Follow-up data provide documentation of long-term effects of EMDR therapy on various outcome variables, most importantly the reduction of PD symptom severity and loss of diagnoses. Trial registration: Netherlands Trial Register NL9078. Registered on 31 November 2020.

Original languageEnglish
Article number196
Pages (from-to)1-15
Number of pages15
JournalTrials
Volume23
DOIs
Publication statusPublished - 4 Mar 2022

Bibliographical note

Funding Information:
All current authors will have access to the final dataset. Some of the contributing researchers who have not contributed to the current article will also have access to the dataset, for example for their thesis or post-graduate education. These researchers will be contractually obligated to treat the data with care and confidentiality. The design of this study was approved by the Medical Research Ethics Committee (MREC) of the Erasmus Medical Centre in Rotterdam, number MEC-2020-0583. All substantial amendments will be notified to the MREC, investigators, trial registry and journal. Non-substantial amendments will not be notified to the accredited MREC investigators, trial registry and journal, but will be recorded and filed by the sponsor. One of the non-blind researchers will obtain informed consent (or assent) using the approved consent form (Appendix C). All data is anonymously collected and stored in Data Manager. However, it is necessary that all non-blind researchers know to whom a participant number correspond, since they enter the participant into Data Manager and generate the number. In all other cases, personal information is only communicated if necessary, for example for measurements, interviews or (EMDR) therapy. Results will be (anonymously) reported and published in scientific journals. Publications will be shared with any individual who contributed to the study in any way (researchers, participants, therapists, institutions, funders, collaborations). Furthermore, publications will be promoted on social media. Access to the full protocol, participant-level dataset and statistical code will be granted on request. According to protocol, 3?4?months after inclusion, all participants will be seen by their primary caretaker, who will investigate whether and which treatment is necessary. Thus, participants who require (further) treatment will remain in treatment at their facility. In addition, all participants are insured for harms up to ?650.000.

Publisher Copyright:
© 2022, The Author(s).

Funding

All current authors will have access to the final dataset. Some of the contributing researchers who have not contributed to the current article will also have access to the dataset, for example for their thesis or post-graduate education. These researchers will be contractually obligated to treat the data with care and confidentiality. The design of this study was approved by the Medical Research Ethics Committee (MREC) of the Erasmus Medical Centre in Rotterdam, number MEC-2020-0583. All substantial amendments will be notified to the MREC, investigators, trial registry and journal. Non-substantial amendments will not be notified to the accredited MREC investigators, trial registry and journal, but will be recorded and filed by the sponsor. One of the non-blind researchers will obtain informed consent (or assent) using the approved consent form (Appendix C). All data is anonymously collected and stored in Data Manager. However, it is necessary that all non-blind researchers know to whom a participant number correspond, since they enter the participant into Data Manager and generate the number. In all other cases, personal information is only communicated if necessary, for example for measurements, interviews or (EMDR) therapy. Results will be (anonymously) reported and published in scientific journals. Publications will be shared with any individual who contributed to the study in any way (researchers, participants, therapists, institutions, funders, collaborations). Furthermore, publications will be promoted on social media. Access to the full protocol, participant-level dataset and statistical code will be granted on request. According to protocol, 3?4?months after inclusion, all participants will be seen by their primary caretaker, who will investigate whether and which treatment is necessary. Thus, participants who require (further) treatment will remain in treatment at their facility. In addition, all participants are insured for harms up to ?650.000.

FundersFunder number
Erasmus Medical Centre in RotterdamMEC-2020-0583
MREC

    Keywords

    • Cost-effectiveness
    • Economic evaluation
    • Effectiveness
    • EMDR
    • Personality disorder
    • Predictors
    • Randomized controlled trial
    • Study protocol
    • Trauma
    • Treatment experiences

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