EMDR Versus Imagery Rescripting as a Treatment for Trauma-Related Intrusive Images
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Severity of intrusions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •the presence of a dissociative identity disorder
- •acute suicide risk
- •acute psychosis
- •substance use disorder
- •bipolar disorder type 1 and
- •Other comorbid disorders are allowed.
结局指标
主要结局
Severity of intrusions
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
Justine De Rous
junior onderzoeker
Geestelijke Gezondheidszorg Eindhoven (GGzE)