EMDR Versus Imagery Rescripting for Trauma-Related Intrusions

NCT06215313 | Enrolling By Invitation

• 1 other identifier: NL85848.068.23
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Disorders, Post-Traumatic; Depression

Keywords

EMDR; Imagery Rescripting; Personalised treatment; Working mechanisms; Intrusions; PTSD; Depression

Outcome Measures

Primary Outcomes (9)

• Severity of intrusions

  The severity of intrusions will be computed as a composite score of the frequency, uncontrollability, and degree of interference with daily life. A questionnaire inquiring about the frequency, uncontrollability, and degree of interference with daily life of intrusions over the previous 4 hours will be administered twice daily via an online questionnaire. A time frame of 2 hours is set within which patients are asked to complete the questionnaire to increase reliability. The items are "How many intrusions did you experience over the previous 4 hours?", "To what extent do these intrusions interfere with your daily life?", and "To what extent do you perceive these intrusions as uncontrollable?". The frequency of intrusions is presented as an open-ended question, while uncontrollability and interference with daily life are measured on a 10-point Likert scale.

  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

  Anxiety and depression will be assessed twice daily using two items (specifically, "How anxious did you feel over the last couple of hours?" and "How depressed did you feel over the last couple of hours?"), using a 10-point VAS scale with as anchor labels 0: "not at all", and 10: "very extreme".

  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

  Emotion regulation is measured by the Difficulties in Emotion Regulation Scale (DERS). A short version has been developed (DERS-SF) and is available in Dutch. Possible scores vary from 18 to 90, with higher scores reflecting greater difficulty with emotion regulation.

  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

  Self-compassion is measured using a shortened version of the Self-Compassion Scale (i.e., SCS-SF). Possible scores range from 12-60, with higher scores reflecting higher self-compassion, and lower scores reflecting lower self-compassion.

  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

  The Ruminative Response Scale (RRS) measures the degree of depressive rumination, or repetitive thinking in response to a low mood. Total scores on the RRS-NL range from 22 to 88, with higher scores reflecting a greater tendency towards ruminative thinking.

  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

  Positive affect is measured using the Positive Affect scale (10 items) of the Positive and Negative Affect Scale (PANAS). High positive affect refers to the extent to which the person feels positively involved in the environment and experiences positive emotions such as enthusiasm, whereas low positive affect refers to the absence of positive feelings. Total scores for the Positive Affect scale range from 10 to 50, with higher scores reflecting greater positive affect.

  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

  The investigators will measure the degree of 'vividness' of intrusions to measure the impact of the interventions. The vividness of intrusions will be measured using an online questionnaire, with the specific item "How vivid are your intrusions right now, on a scale from 0 to 100?", with higher scores reflecting higher vividness.

  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

  The investigators will measure the level of 'distress' of intrusions to measure the impact of the interventions. The distress of intrusions will be measured using an online questionnaire, with the specific item "How distressing are your intrusions right now, on a scale from 0 to 100?", with higher scores reflecting higher distress.

  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

  The investigators will assess the content and believability of 'intrusion-related beliefs about oneself', in order to measure the change in the meanings associated with the intrusions. This outcome measure will be assessed using an online questionnaire, with the specific items "What do your intrusions say about you?" (open ended question), and "How believable is this belief right now, on a scale from 0 to 100?", with higher scores reflecting stronger intrusion-related beliefs about oneself.

  Intrusion-related beliefs are assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.

Secondary Outcomes (4)

• The Posttraumatic Stress Disorder Checklist for DSM-5

  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

  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

  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

  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.

Other Outcomes (2)

• MINI Neuropsychiatric Interview

  The MINI Interview will be administered at the pre-intervention assessment (2 weeks prior to the first treatment session) to determine whether a patient meets the inclusion criteria and to describe other comorbidities in the sample.

• Life Events Checklist for the DSM-5

  The LEC-5 will be administered at the pre-intervention assessment (2 weeks prior to the first treatment session).

Study Arms (3)

Patients with PTSD

EXPERIMENTAL

Patients with PTSD will be randomly assigned to either EMDR or IR. They will receive two 75-minute sessions of either EMDR or IR each week, with one additional coaching session in both conditions (EMDR and IR).

Behavioral: Eye Movement Desensitization and Reprocessing; Behavioral: Imagery Rescripting

Patients with depression

EXPERIMENTAL

Patients with depression will be randomly assigned to either EMDR or IR. They will receive two 75-minute sessions of either EMDR or IR each week, with one additional coaching session in both conditions (EMDR and IR).

Behavioral: Eye Movement Desensitization and Reprocessing; Behavioral: Imagery Rescripting

Patients with PTSD and depression

EXPERIMENTAL

Patients with PTSD and depression will be randomly assigned to either EMDR or IR. They will receive two 75-minute sessions of either EMDR or IR each week, with one additional coaching session in both conditions (EMDR and IR).

Behavioral: Eye Movement Desensitization and Reprocessing; Behavioral: Imagery Rescripting

Interventions

Eye Movement Desensitization and Reprocessing BEHAVIORAL

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 while following the movement of a light bar or the therapist's fingers with their eyes (i.e., eye tracking task). Then, in the installation phase, the patient focuses on the positive cognition during the eye tracking task. When the validity of the positive cognition is 6 to 7 on a 7-point Likert scale, a body scan is performed to ensure that no unresolved traumatic material remains. Each session ends with a reflection and debriefing.

Also known as: EMDR

Patients with PTSD; Patients with PTSD and depression; Patients with depression

Imagery Rescripting BEHAVIORAL

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 may involve the therapist or patient intervening in the situation, ensuring the patient's emotional needs are met. The patient then relives the memory from the point of view of their younger self, with the adult-self intervening in the scene. The process continues until all emotional needs are fulfilled. Generally, one trauma memory is rescripted per session. The initial IR session involves therapist-led rescripting, with subsequent sessions encouraging patient-led rescripting whenever possible.

Also known as: IR

Patients with PTSD; Patients with PTSD and depression; Patients with depression

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Geestelijke Gezondheidszorg Eindhoven (GGzE): lead
• Maastricht University: collaborator

Study Sites (1)

Geestelijke Gezondheidszorg Eindhoven

Eindhoven, North Brabant, 5626 ND, Netherlands

Location

Related Publications (19)

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• 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

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• Overbeek, T., & Schruers, K. (2019). Mini International Neuropsychiatric Interview - Simplified (MINIS) voor DSM-5, Nederlandse versie.

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• Raes, F. (2009). Ruminative Response Scale--Revised; Dutch Version (RRS-NL, RRS) [Database record]. APA PsycTests. https://doi.org/10.1037/t66234-000

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• Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

  PMID: 21584907 BACKGROUND

• Shapiro F. (2001). Eye movement desensitization and reprocessing (EMDR): basic principles, protocols and procedures. 2nd ed. New York, NY: The Guilford Press.

  BACKGROUND

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• van Krugten FC, Kaddouri M, Goorden M, van Balkom AJ, Bockting CL, Peeters FP, Hakkaart-van Roijen L; Decision Tool Unipolar Depression (DTUD) Consortium. Indicators of patients with major depressive disorder in need of highly specialized care: A systematic review. PLoS One. 2017 Feb 8;12(2):e0171659. doi: 10.1371/journal.pone.0171659. eCollection 2017.

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• Weathers, F.W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marx, B. P., & Schnurr, P. P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Retrieved on December 1, 2023 from https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp#obtai

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: junior onderzoeker

Model Details: This study will use a single-case experimental design (SCED). In this study, there are three groups (PTSD, depression, and PTSD with comorbid depression) and two interventions (EMDR and IR), that is 3 x 2 = 6 simultaneous SCEDs. Seven patients per SCED will be included, i.e., a total of 42 patients. Patients will be randomly assigned to one of the two interventions.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 22, 2024
• Study Start: January 28, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

NL (1)