EMDR Treatment in PTSD Following Cardiac Events
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Interview-rated posttraumatic stress 3 months Follow-up
研究概览
简要总结
Cardiac events can often result in debilitating and persistent psychological symptoms. A key question involves whether optimal treatment of cardiac-induced posttraumatic stress disorder (PTSD) reduces PTSD symptoms and thereby may offset the risk of recurrent or worsening cardiovascular disease. Cardiac-induced PTSD 1) is prevalent, 2) features symptoms unique to internal ongoing somatic threat, with fears and worries that can be distinguished from PTSD resulting from external causes, 3) is persistent, 4) is associated with negative physical and emotional consequences, and 5) has not been the subject of randomized-controlled treatment trials (RCT). There is preliminary evidence suggesting that patients with cardiac-disease induced PTSD might particularly profit from EMDR. Nevertheless, this possibility has not been tested in cardiac-induced PTSD. Currently, patients with cardiac-induced PTSD are not routinely offered trauma-focused therapies, with a lack of scientific evidence likely being one major reason for this omission. If our proposed RCT shows that EMDR can be an effective treatment for patients with ACS-induced PTSD, EMDR could be routinely implemented as first-line treatment. The RCT outcomes might inform larger trials to test whether poor prognosis in terms of major adverse cardiovascular events can be improved through EMDR in patients with cardiac-induced PTSD.
详细描述
There is a lack of research on the efficacy of psychotherapy and especially EMDR in clinical-induced PTSD. In the light of clinical-induced PTSD having different symptoms than traditional PTSD, this lack of research is highly problematic. Specifically, the unique symptom profile in clinical-induced PTSD related to the enduring somatic threat model was not addressed in any of the studies targeting PTSD in cardiac patients. In this regard, EMDR might be most promising: The EMDR protocol includes the assessment of body sensations associated with the target event, which is followed by reprocessing. The bilateral eye movements during reprocessing seem to have de-arousing effects and may thereby interrupt the positive feedback loop between cardiovascular sensations and anxiety-induced arousal as explained by the enduring somatic threat model. Hence, EMDR might be more suitable in cardiac PTSD patients compared to treatment protocols that motivates patients to keep focusing on the traumatic event such as Prolonged Exposure, where higher emotional involvement seems to be related to a better outcome.
Therefore, the here proposed study aims at testing EMDR therapy in c,jj
-induced PTSD in a randomized controlled trial.The here proposed study aims at testing EMDR therapy in ACS-induced PTSD in a randomized controlled trial. More specifically, the efficacy of the standardized trauma-focused procedure in terms of a reduced PTSD symptom level will be tested against a passive waitlist control group.
Intervention group:
The intervention group consists of 30 patients diagnosed with PTSD induced by cardiac events. Eight individual EMDR sessions lasting for 1 hours will be provided over 8 weeks by licensed EMDR therapists from the German-speaking part of Switzerland. Each EMDR session follows a standardized 8-phase protocol. As Shapiro posits that it is necessary to adapt the standard procedures to the unique needs and characteristics of the patient and to apply different EMDR protocols for different pathologies, the therapy for cardiac events was adapted from the standard protocol.
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
- Single (Outcomes Assessor)
盲法说明
Assessors who ascertain the primary outcome variable, i.e. CAPS scores, will be blind to the subject's treatment condition. Randomization will be conducted by a person outside of the study team.
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 18-70 years
- •Men or women
- •STEMI (irrespective of troponin, but ST-elevation) or non-STEMI (troponin positive) at the time of the cardiac event, as verified by the cardiologist
- •Diagnosis of PTSD caused by the cardiac event
排除标准
- •Psychotic disorder, bipolar disorder, substance abuse as measured with the Mini International Neuropsychiatric Interview (M.I.N.I)
- •Acute suicidal ideation as assessed with the M.I.N.I.
- •Non-selective beta blockers (e.g., propranolol) during the study period
- •Ongoing psychological/psychiatric treatment outside of the trial during the study period
- •Visionary problems, e.g. strabismus, which does not allow adequate eye movements
- •Insufficient knowledge of the German language
- •Expected inability or willingness to follow the study protocol
- •Regular medication with benzodiazepine
结局指标
主要结局
Interview-rated posttraumatic stress 3 months Follow-up
时间窗: 3 months
The primary endpoint is the interviewer-rated posttraumatic stress level at three months follow-up (by means of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), with a range from 0-160, whereby higher scores mean a worse outcome).
Interview-rated posttraumatic stress 6 months Follow-up
时间窗: 6 months
The primary endpoint is the interviewer-rated posttraumatic stress level at six months follow-up (by means of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), with a range from 0-160, whereby higher scores mean a worse outcome).
次要结局
- Stress hormones - Epinephrine 6 months(6 months)
- Cardiometabolic biomarkers - metabolic factors 3 months(3 months)
- Cardiometabolic biomarkers - metabolic factors 6 months(6 months)
- Cardiometabolic biomarkers - inflammation markers 3 months(3 months)
- Cardiometabolic biomarkers - inflammation markers 6 months(6 months)
- Nose-related psychophysiological stress responses - Heart Rate 3 months(3 months)
- Nose-related psychophysiological stress responses - Heart Rate Variability 3 months(3 months)
- Nose-related psychophysiological stress responses - Skin Conductance 3 months(3 months)
- Stress hormones - Epinephrine 3 months(3 months)
- Nose-related psychophysiological stress responses - Heart Rate 6 months(6 months)
- Stress hormones - Plasma Norepinephrine 3 months(3 months)
- Nose-related psychophysiological stress responses Skin Conductance - 6 months(6 months)
- Nose-related psychophysiological stress responses - Heart Rate Variability - 6 months(6 months)
- Stress hormones - Plasma Norepinephrine - 6 months(6 months)
- Stress hormones - Cortisol 3 months(3 months)
- Stress hormones - Salivary Cortisol 6 months(6 months)