EMDR Versus Imagery Rescripting for Trauma-Related Intrusions

NCT ID: NCT06215313

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-28

Study Completion Date

2026-11-30

Brief Summary

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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

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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.

Conditions

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Stress Disorders, Post-Traumatic Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with PTSD

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).

Group Type EXPERIMENTAL

Eye Movement Desensitization and Reprocessing

Intervention Type 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.

Imagery Rescripting

Intervention Type 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.

Patients with depression

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).

Group Type EXPERIMENTAL

Eye Movement Desensitization and Reprocessing

Intervention Type 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.

Imagery Rescripting

Intervention Type 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.

Patients with PTSD and depression

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).

Group Type EXPERIMENTAL

Eye Movement Desensitization and Reprocessing

Intervention Type 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.

Imagery Rescripting

Intervention Type 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.

Interventions

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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 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.

Intervention Type 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 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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EMDR IR

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University

OTHER

Sponsor Role collaborator

Geestelijke Gezondheidszorg Eindhoven (GGzE)

OTHER

Sponsor Role lead

Responsible Party

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Justine De Rous

junior onderzoeker

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Geestelijke Gezondheidszorg Eindhoven

Eindhoven, North Brabant, Netherlands

Site Status

Countries

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Netherlands

References

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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.

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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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Topper M, Emmelkamp PM, Watkins E, Ehring T. Development and assessment of brief versions of the Penn State Worry Questionnaire and the Ruminative Response Scale. Br J Clin Psychol. 2014 Nov;53(4):402-21. doi: 10.1111/bjc.12052. Epub 2014 May 2.

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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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Other Identifiers

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NL85848.068.23

Identifier Type: -

Identifier Source: org_study_id

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