Stress Disorders, Post-TraumaticNCT06215313
EMDR Versus Imagery Rescripting for Trauma-Related Intrusions
A study testing Eye Movement Desensitization and Reprocessing and Imagery Rescripting in people with Stress Disorders, Post-Traumatic and Depression, run by Geestelijke Gezondheidszorg Eindhoven (GGzE) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Depression
- What is being tested?
- Eye Movement Desensitization and Reprocessing and Imagery Rescripting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Jan 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Geestelijke Gezondheidszorg Eindhoven
Eindhoven, North Brabant, 5626 ND
About this study
Official title: EMDR Versus Imagery Rescripting as a Treatment for Trauma-Related Intrusive Images
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.
Read more
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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic, Depression
- Being tested
- Eye Movement Desensitization and Reprocessing, Imagery Rescripting
- Keywords
- EMDR, Imagery Rescripting, Personalised treatment, Working mechanisms, Intrusions, PTSD, Depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and ReprocessingBehavioural
Also called EMDR
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 RescriptingBehavioural
Also called IR
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Behavioral: Eye Movement Desensitization and Reprocessing; Behavioral: Imagery Rescripting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire that measures the severity of PTSD symptoms in the past month. The PCL-5 contains four subscales: Intrusions (items 1-5), Avoidance (items 6-7), Negative Change in Cognitions and Mood (NACM; items 8-14), and Change in Arousal and Reactivity (AR; items 15-20).
Measured: 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 Beck Depression Inventory II (BDI-II) is a 21-item self-report questionnaire that measures the severity of depressive symptoms over the past 2 weeks. Possible scores range from 21 to 63, with higher scores reflecting more severe depressive symptoms.
Measured: 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 Dutch version of the Mental Health Quality of Life 7D (MHQoL) measures quality of life in people with mental health problems. The instrument consists of 7 self-report items in the domains of self-image, independence, mood, relationships, daily activities, physical health, and future. Possible scores range from 0 to 21, with higher scores reflecting a higher quality of life.
Measured: 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 Credibility/Expectancy Questionnaire (CEQ) is a questionnaire that consists of six questions: four questions considering the treatment credibility, and two questions considering treatment expectancy.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start28 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geestelijke Gezondheidszorg Eindhoven (GGzE)
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Justine De Rous, Geestelijke Gezondheidszorg Eindhoven (GGzE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215313
- Sponsor's protocol ID
- NL85848.068.23
- Status last verified
- Mar 2025
- First submitted
- 14 Dec 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 10452174Beck, 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.
PubMed 41522882Amorim 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.
PubMed 19698595Neff, 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
Neff KD, Vonk R. Self-compassion versus global self-esteem: two different ways of relating to oneself. J Pers. 2009 Feb;77(1):23-50. doi: 10.1111/j.1467-6494.2008.00537.x. Epub 2008 Nov 28.
PubMed 19076996Neumann A, van Lier PA, Gratz KL, Koot HM. Multidimensional assessment of emotion regulation difficulties in adolescents using the Difficulties in Emotion Regulation Scale. Assessment. 2010 Mar;17(1):138-49. doi: 10.1177/1073191109349579. Epub 2009 Nov 14.
PubMed 19915198Nolen-Hoeksema S, Morrow J. A prospective study of depression and posttraumatic stress symptoms after a natural disaster: the 1989 Loma Prieta Earthquake. J Pers Soc Psychol. 1991 Jul;61(1):115-21. doi: 10.1037//0022-3514.61.1.115.
PubMed 1890582Overbeek, T., & Schruers, K. (2019). Mini International Neuropsychiatric Interview - Simplified (MINIS) voor DSM-5, Nederlandse versie.
Raes, F. (2009). Ruminative Response Scale--Revised; Dutch Version (RRS-NL, RRS) [Database record]. APA PsycTests. https://doi.org/10.1037/t66234-000
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.
PubMed 21584907Shapiro F. (2001). Eye movement desensitization and reprocessing (EMDR): basic principles, protocols and procedures. 2nd ed. New York, NY: The Guilford Press.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMDR Versus Imagery Rescripting as a Treatment for Trauma-Related Intrusive Images
- ClinicalTrials.gov ID
- NCT06215313
- Acronym / sponsor ID
- NL85848.068.23
- Conditions
- Stress Disorders, Post-Traumatic, Depression
- Keywords
- EMDR, Imagery Rescripting, Personalised treatment, Working mechanisms, Intrusions, PTSD, Depression
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Geestelijke Gezondheidszorg Eindhoven (GGzE)University, hospital or other
- Collaborators
- Maastricht University
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with PTSD | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing, Behavioral: Imagery RescriptingPatients 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). |
| Patients with depression | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing, Behavioral: Imagery RescriptingPatients 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). |
| Patients with PTSD and depression | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing, Behavioral: Imagery RescriptingPatients 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Movement Desensitization and ReprocessingAlso: EMDRIn 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. | Behavioural | Patients with PTSD, Patients with PTSD and depression, Patients with depression |
| Imagery RescriptingAlso: IRThe 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. | Behavioural | Patients with PTSD, Patients with PTSD and depression, Patients with depression |
Primary outcome
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.
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.
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.
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".
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 10452174Arntz 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.
- BackgroundBeck, A. T., Steer, R., Brown, G. (1996). Manual for the Beck Depression Inventory-II. San Antonio: The Psychological Corporation.
- BackgroundBoeschoten, 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
- BackgroundDe 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.
- BackgroundGratz, 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
- Background: PubMed 41522882Kaufman 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.
- Background: PubMed 19698595Amorim 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.
- BackgroundNeff, 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
- Background: PubMed 19076996Neff KD, Vonk R. Self-compassion versus global self-esteem: two different ways of relating to oneself. J Pers. 2009 Feb;77(1):23-50. doi: 10.1111/j.1467-6494.2008.00537.x. Epub 2008 Nov 28.
- Background: PubMed 19915198Neumann A, van Lier PA, Gratz KL, Koot HM. Multidimensional assessment of emotion regulation difficulties in adolescents using the Difficulties in Emotion Regulation Scale. Assessment. 2010 Mar;17(1):138-49. doi: 10.1177/1073191109349579. Epub 2009 Nov 14.
- Background: PubMed 1890582Nolen-Hoeksema S, Morrow J. A prospective study of depression and posttraumatic stress symptoms after a natural disaster: the 1989 Loma Prieta Earthquake. J Pers Soc Psychol. 1991 Jul;61(1):115-21. doi: 10.1037//0022-3514.61.1.115.
- BackgroundOverbeek, T., & Schruers, K. (2019). Mini International Neuropsychiatric Interview - Simplified (MINIS) voor DSM-5, Nederlandse versie.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing and Imagery Rescripting in people with Stress Disorders, Post-Traumatic and Depression, run by Geestelijke Gezondheidszorg Eindhoven (GGzE) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06215313, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.