EMDR Versus Imagery Rescripting for Trauma-Related Intrusions

Official title

EMDR Versus Imagery Rescripting as a Treatment for Trauma-Related Intrusive Images

Overview

The goal of this clinical trial is to investigate the effectiveness and mechanisms of action of trauma treatments in a sample of patients meeting criteria for posttraumatic stress disorder (PTSD), unipolar depression, or both disorders. The main questions it aims to answer are: * which first line treatment (Eye Movement Desensitization and Reprocessing \[EMDR\] vs. Imaginary Rescripting \[IR\]) works better for intrusive experiences in patients with PTSD, patients with a depression, and patients who meet criteria for both diagnoses. * which mechanisms of action cause the treatment effects. Participants will * be randomly assigned to a standard treatment of EMDR or IR * complete daily questionnaires measuring the outcome measures two weeks before the start of their treatment, during their EMDR or IR treatment, and for one month after their treatment. * complete questionnaires measuring the outcome measures and secondary outcome measures at pre-intervention, post-treatment (i.e., 4 weeks after the last intervention session, at the end of the withdrawal phase), and at 6-month follow-up.

Detailed description

Rationale: Patients with post-traumatic stress disorder (PTSD) experience highly frequent and distressing intrusive images depicting earlier aversive experiences. Not only patients with PTSD experience these intrusions; they are also very common in depression. Therefore, trauma treatments that target these intrusions may also benefit patients with depression. Additionally, comorbid depression in patients with PTSD reduces the effects of trauma treatment. It is currently unknown which treatment for traumatic intrusions is most effective for patients who meet criteria for PTSD, depression, or both, and treatment selection is often a process of trial and error. The mechanisms of action of trauma treatments may inform us how to select the most appropriate treatment for a particular individual.

Objective:

The investigators' primary objective is to investigate which treatment (EMDR vs. IR) is most effective for different groups of patients who experience intrusions: patients with PTSD, patients with depression, or patients with PTSD and a comorbid depression. To this end, the investigators will examine the reduction in the severity of intrusions (i.e., frequency, uncontrollability, and degree of interference with daily life). The investigators' secondary objective is to gain more insight into the mechanisms of action of EMDR and IR. To this end, the investigators will examine the role of various mediators of the treatment effects (i.e., the reduction in the severity of intrusions). The investigators will specifically investigate the potential mediating roles of self-compassion, emotion regulation, positive affect, rumination, and the vividness, distress, and associated meaning of intrusions.

Study design: This study will use a single-case experimental design (SCED). In this design, a small group of patients is followed throughout their treatment. It is a within-subjects design in which each patient undergoes a baseline phase (2 weeks prior to the start of treatment) in which no intervention takes place, an experimental phase with treatment interventions (at least 2.5 weeks), and finally a withdrawal phase (4 weeks following the last intervention session) in which no further treatment takes place.

Study population: This study will recruit 42 patients meeting criteria for either PTSD or depression, or for both disorders.

Intervention (if applicable): Patients will be randomly assigned to standard treatments EMDR or IR. In each condition, patients will receive two 75-minute sessions of EMDR or IR each week, as well as an additional coaching session each week. Treatment length depends on patients' needs and varies between 2.5 and 6 weeks.

Main study parameters/endpoints: The primary outcome is a brief measure of characteristics of intrusions (specifically, the frequency, uncontrollability, and degree of interference with daily life), which will be assessed twice daily via an online mobile app.

Additionally, process measures indexing possible mediators concern brief questionnaires on emotion regulation, self-compassion, rumination, positive affect, and the vividness, distress, and related meaning of intrusions, which also serve as the investigators' primary outcome measures. These questionnaires will be assessed daily. All primary outcome measures will be administered during the baseline, experimental, and withdrawal phase. Secondary outcome measures concern questionnaires on quality of life, depression symptoms, and PTSD symptoms which are endorsed at the pre-intervention assessment (i.e., 2 weeks prior to the first intervention session), post-treatment assessment (i.e., 4 weeks after the last intervention session, at the end of the withdrawal phase), and at 6-month follow-up assessment.

Interventions

• Behavioral Eye Movement Desensitization and Reprocessing
  In the EMDR condition, the Dutch version of the treatment protocol based on Shapiro's original work (2001) is followed. In the first session, the rationale of EMDR is explained. The patient describes the memory, and identifies the most aversive still image, the associated negative cognition, desired positive cognition, feelings, somatic sensations, and perceived tension, as measured by Subjective Unit of Distress (SUDs). Desensitization then begins by asking patients to focus on the still image
• Behavioral Imagery Rescripting
  The IR condition, following Arntz and Weertman's (1999) protocol, addresses traumatic or aversive memories by creating alternative scenarios. In the first session, the method is explained. The patient describes their memory in the present tense, from the first-person perspective, and describes associated feelings, thoughts, and emotional needs. The therapist then seeks permission to 'enter' the scene, guiding the patient to visualise an alternative, emotionally satisfying course of events. This

Primary outcome measures

• Severity of intrusions [Time frame: Severity of intrusions is assessed 2x daily from 2 weeks before treatment up to 1 month after treatment. The severity of intrusions is also assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]
• Anxiety and depression [Time frame: Anxiety and depression are assessed 2x daily from 2 weeks before treatment up to 1 month after treatment. Anxiety and depression are also assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]
• Emotion regulation [Time frame: The DERS-18 Strategies subscale (3 items) is assessed daily from 2 weeks before treatment up to 1 month after treatment. The entire DERS-SF is administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]
• Self-compassion [Time frame: Self-compassion subscale (6 items) is administered daily from 2 weeks before treatment up to 1 month after treatment. The entire SCS-SF is administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]
• Rumination [Time frame: Brooding and reflection subscales (5 items) are assessed daily from 2 weeks before treatment up to 1 month after treatment. The entire RRS is administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]
• Positive affect [Time frame: Positive affect items (10 items) are assessed daily from 2 weeks before treatment up to 1 month after treatment. The entire PANAS will be assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]
• Vividness of intrusions [Time frame: Vividness of intrusions is assessed daily from 2 weeks before treatment up to 1 month after treatment. The vividness of intrusions is also assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]
• Distress of intrusions [Time frame: Distress of intrusions is assessed daily from 2 weeks before treatment up to 1 month after treatment. Additionally, the distress of intrusions is assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]
• Intrusion-related beliefs [Time frame: Intrusion-related beliefs are assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]

Secondary outcome measures (4)

• The Posttraumatic Stress Disorder Checklist for DSM-5 [Time frame: The PCL-5 will be administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]
• The Beck Depression Inventory II [Time frame: The BDI-II will be administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]
• Mental Health Quality of Life 7D [Time frame: The MHQoL will be administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]
• The Credibility/Expectancy Questionnaire [Time frame: The CEQ is assessed twice weekly from 2 weeks before treatment up to 1 month after treatment. The CEQ is also assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.]

Eligibility criteria

Inclusion criteria

• age between 18 and 70 years
• experiencing intrusions and/or nightmares
• meet criteria for unipolar depressive disorder, PTSD, or both disorders
• past aversive events still cause considerable distress
• be available for trauma treatment twice a week, with an additional coaching session each week
• be proficient in the Dutch language.

Exclusion criteria

• the presence of a dissociative identity disorder
• acute suicide risk
• acute psychosis
• substance use disorder
• bipolar disorder type 1 and 2. Other comorbid disorders are allowed.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Netherlands · 1 center

• Geestelijke Gezondheidszorg Eindhoven — Eindhoven

Publications

• Arntz A, Weertman A. Treatment of childhood memories: theory and practice. Behav Res Ther. 1999 Aug;37(8):715-40. doi: 10.1016/s0005-7967(98)00173-9. PMID 10452174
• Beck, A. T., Steer, R., Brown, G. (1996). Manual for the Beck Depression Inventory-II. San Antonio: The Psychological Corporation.
• Boeschoten, M.A., Bakker, A., Jongedijk, R.A., & Olff, M. (2014). PTSD Checklist for DSM-5-Nederlandstalige versie. Uitgave: Stichting Centrum '45, Arq Psychotrauma Expert Groep, Diemen
• De Jongh, A., & Ten Broeke, E. (2013). Handboek EMDR: Een geprotocolleerde behandelmethode voor de gevolgen van psychotrauma [EMDR manual: A protocolised treatment method for the consequences of psychotrauma]. Amsterdam: Pearson Assessment and Information B.V.
• Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26(1), 41-54. https://doi.org/10.1023/B:JOBA.0000007455.08539.94
• Kaufman EA, Xia M, Fosco G, Yaptangco M, Skidmore CR, Crowell SE. The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and Replication in Adolescent and Adult Samples. J Psychopathol Behav Assess. 2016 Sep;38(3):443-455. doi: 10.1007/s10862-015-9529-3. Epub 2015 Nov 23. PMID 41522882
• Amorim P, Lecrubier Y, Weiller E, Hergueta T, Sheehan D. DSM-IH-R Psychotic Disorders: procedural validity of the Mini International Neuropsychiatric Interview (MINI). Concordance and causes for discordance with the CIDI. Eur Psychiatry. 1998;13(1):26-34. doi: 10.1016/S0924-9338(97)86748-X. PMID 19698595
• Neff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and Identity, 2(3), 223-250. https://doi.org/10.1080/15298860309027

Identifiers

NCT: NCT06215313 · NL85848.068.23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗