Clinical trial NCT06215313: EMDR Versus Imagery Rescripting for Trauma-Related Intrusions
Official title: EMDR Versus Imagery Rescripting as a Treatment for Trauma-Related Intrusive Images
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Depression
Keywords: EMDR
Imagery Rescripting
Personalised treatment
Working mechanisms
Intrusions
PTSD
Depression
Lead sponsor: Geestelijke Gezondheidszorg Eindhoven (GGzE)
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2024-01-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Severity of intrusions
timeFrame: 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.
measure: Anxiety and depression
timeFrame: 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.
measure: Emotion regulation
timeFrame: 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.
measure: Self-compassion
timeFrame: 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.
measure: Rumination
timeFrame: 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.
measure: Positive affect
timeFrame: 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.
measure: Vividness of intrusions
timeFrame: 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.
measure: Distress of intrusions
timeFrame: 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.
measure: Intrusion-related beliefs
timeFrame: 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:
measure: The Posttraumatic Stress Disorder Checklist for DSM-5
timeFrame: The PCL-5 will be administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
measure: The Beck Depression Inventory II
timeFrame: The BDI-II will be administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
measure: Mental Health Quality of Life 7D
timeFrame: The MHQoL will be administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
measure: The Credibility/Expectancy Questionnaire
timeFrame: 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:
measure: MINI Neuropsychiatric Interview
timeFrame: 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.
measure: Life Events Checklist for the DSM-5
timeFrame: The LEC-5 will be administered at the pre-intervention assessment (2 weeks prior to the first treatment session).
Locations:
city: Eindhoven
country: Netherlands
facility: Geestelijke Gezondheidszorg Eindhoven
state: Noord-Brabant
Study officials:
References:
citation: 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.
citation: Beck, A. T., Steer, R., Brown, G. (1996). Manual for the Beck Depression Inventory-II. San Antonio: The Psychological Corporation.
citation: 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
citation: 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.
citation: 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
citation: Kaufman, E. A., Xia, M., Fosco, G., Yaptangco, M., Skidmore, C. R., & Crowell, S. E. (2016). The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and replication in adolescent and adult samples. Journal of Psychopathology and Behavioral Assessment, 38(3), 443-455. https://doi.org/10.1007/s10862-015-9529-3
citation: 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.
citation: 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
citation: 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.
citation: Neumann 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.
citation: Nolen-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.
citation: Overbeek, T., & Schruers, K. (2019). Mini International Neuropsychiatric Interview - Simplified (MINIS) voor DSM-5, Nederlandse versie.
citation: Raes, F. (2009). Ruminative Response Scale--Revised; Dutch Version (RRS-NL, RRS) [Database record]. APA PsycTests. https://doi.org/10.1037/t66234-000
citation: 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.
citation: Shapiro F. (2001). Eye movement desensitization and reprocessing (EMDR): basic principles, protocols and procedures. 2nd ed. New York, NY: The Guilford Press.
citation: 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.
citation: 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.
citation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
citation: 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