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临床试验/NCT03848858
NCT03848858已完成不适用

The Efficacy of Eye Movement Desensitization and Reprocessing Therapy Versus Treatment-As-Usual in a Pilot Randomized Controlled Trial in Reducing Clinical Symptoms and Biological Markers of HIV in Patients With a Recent Diagnosis of HIV

Parc de Salut Mar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Psychological trauma

研究概览

简要总结

People living with HIV may suffer HIV-related psychological trauma. Studies also show that this group is vulnerable to non-HIV-related trauma. Trauma can increase vulnerability to stress and reducing the ability to cope. It can have a negative impact on treatment adherence, treatment outcomes, functioning and health-related quality of life. However, despite evidence showing psychological trauma can contribute to poor outcomes in HIV, little research has been carried out to assess whether psychological trauma-focused therapy can help people living with HIV.

A first-line treatment for psychological trauma is Eye Movement Desensitization and Reprocessing (EMDR) therapy. This therapy is recommended by the World Health Organization for treating Post-Traumatic Stress Disorder, with many studies showing this treatment is safe and effective for this disorder. However, it has not to our knowledge been specifically tested in the population of people living with HIV. This project will test whether EMDR therapy, in addition to the standard medical treatment received at the Infectious Diseases Unit, is more effective than standard medical treatment alone in reducing psychological trauma, improving health-related quality of life and improving HIV outcomes in people recently diagnosed with HIV. To test this, the investigators will recruit 40 people who have received a diagnosis of HIV. 20 will be offered the possibility to receive EMDR treatment for one hour weekly for up to 6 months, in addition to the standard medical treatment, while the other 20 will be offered only the standard medical treatment. The hypotheses of the present study are that the participants who receive EMDR therapy on top of their standard medical treatment will show a reduction in psychological trauma and related symptoms such as anxiety, depression and global distress, as compared to those who did not. The investigators also predict that the EMDR group will show improved functioning and health-related quality of life. The final hypotheses are that the EMDR group will show improved treatment adherence and HIV outcomes. If this study shows that a psychological trauma-focused therapy can help people adjust to a HIV diagnosis and have better outcomes, this will have important implications for improving care for people living with HIV.

详细描述

Background

The seropositive population are vulnerable to high rates of psychological trauma with 30-40% of people living with HIV having HIV-related trauma, and rates of up to 90% of trauma unrelated to HIV. HIV-related trauma is linked to various events such as receiving the diagnosis, the number of medical symptoms, receiving treatment, the level of perceived stigma related to HIV, and witnessing HIV-related deaths. The risk of suffering trauma related to HIV is higher in those with prior trauma and negative life event.

Trauma is known to not only have a serious impact on mental health, but also to be a key predictor of poor prognosis in HIV, affecting treatment outcomes and health-related quality of life. Trauma exposure and the development of trauma symptoms impair psychosocial functioning, increase vulnerability to stress and burden the physiological systems involved in coping and adaptation. Patients with posttraumatic symptoms show poorer treatment adherence, yet even in therapy-adherent individuals, posttraumatic symptoms are associated with immune dysregulation, leading to decreased CD4 cell count and thus negative health outcomes. Trauma-affected patients are also more likely to engage in risky health-related behaviors and to suffer higher functional impairment not explained by CD4 count variance.

Due to the negative impact of trauma in terms of psychological distress and poorer HIV outcomes, psychological interventions which specifically address trauma are needed as an adjunct to antiretroviral treatment, in order to reduce unnecessary mortality related to poor treatment adherence and to improve health-related quality of life and functionality. There is even potential for psychological interventions to impact directly on HIV disease progression. Limited evidence suggests that psychological interventions targeting trauma can have a positive impact on HIV symptom experience, while a small but promising body of research into Mindfulness-based interventions targeted at reducing stress show they may have a positive impact on the biological HIV marker CD4. Therefore, a brief yet effective psychological intervention at the point of diagnosis could have a significant impact in reducing psychological trauma and distress and improving treatment adherence and thus prognosis, and may even improve HIV disease progression.

One of the first-line treatments for trauma in non-HIV populations is Eye Movement Desensitization and Reprocessing (EMDR) therapy. EMDR is a psychotherapeutic approach developed in the late 80s by Francine Shapiro that aims to treat traumatic memories and their associated stress symptoms. This therapy consists of a standard protocol which includes eight phases and bilateral stimulation (usually horizontal saccadic eye movements) to desensitize the discomfort caused by traumatic memories and the aim of the therapy is to achieve their reprocessing and integration within the patient's standard biographical memories. EMDR therapy is recommended by the World Health Organization as a psychotherapy of choice in the treatment of PTSD, showing efficacy in children, teenagers, and adults. Recent studies show potential for EMDR as an efficacious treatment in non-PTSD patients, including in promoting treatment adherence in bipolar patients and as an add-on treatment in chronic pain conditions, as per a recent review. Therefore, EMDR would seem to be indicated as an interesting therapeutic tool in helping people successfully assimilate the HIV diagnosis and reduce psychological distress and psychological trauma symptoms, and as an adjuvant treatment to health-related quality of life and potentially treatment adherence and biological markers of the disease.

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

Evaluators will be blind to treatment. Participants cannot be blind to treatment due to the impossibility of creating a sham alternative to EMDR therapy, due to its use of bilateral stimulation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with HIV within last 1 month
  • Aged 18 - 65
  • Impact of Events Scale-Revised score of higher than 0 related to HIV diagnosis
  • Fluency in Spanish
  • Initiating antiretroviral medication

排除标准

  • Diagnosis of severe mental disorder or neurological disorder
  • Current suicidal ideation
  • Current substance use disorder
  • Have received a structured therapy for trauma in the past 2 years (for part 2 of the study only)
  • Clinical diagnosis of AIDS.

研究组 & 干预措施

TAU only

No Intervention

The patients in this condition are newly diagnosed and will be introduced to the study in their first appointment with the Infectious Diseases Unit, in which analyses of HIV-related biological markers are taken. In a follow up appointment between 1 and 2 weeks later, antiretroviral treatment is initiated. There is a further check-up 1-2 months after initiating antiretroviral treatment, and then 6-monthly check-ups. In these checkups, measures of CD4 and the CD4/CD8 ratio are taken and treatment adherence is reviewed. The patients receiving EMDR therapy will also participate in these activities.

EMDR plus TAU

Experimental

20 individual weekly sessions of 60 minutes each of Eye Movement Desensitization and Reprocessing Therapy (EMDR), plus Treatment as Usual (TAU), applying first the standard EMDR protocol (Shapiro, 2005), and then a specific protocol for the sequelae of somatic illness and medical trauma (Hase, 2018).

干预措施: EMDR plus TAU (Behavioral)

结局指标

主要结局

Psychological trauma

时间窗: From baseline to posttreatment at 6 months

Psychological trauma will be evaluated using the Impact of Events Scale-Revised. This scale consists in 22-item to determine frequency and impact of posttraumatic symptoms experienced, with subscales of intrusion, avoidance and hyperarousal, each scored on a 5-point Likert scale, yielding a score for each subscale and a total score. This scale has a scoring range of 0 to 88. On this test, scores that exceed 24 can be quite meaningful. High scores have the following associations: 24 or more PTSD is a clinical concern. Those with scores this high who do not have full PTSD will have partial PTSD or at least some of the symptoms; 33 and above represents the best cutoff for a probable diagnosis of PTSD; 37 or more this is high enough to suppress your immune system's functioning (even 10 years after an impact event).

次要结局

  • Dissociative symptoms(From baseline to posttreatment at 6 months)
  • Anxiety(From baseline to posttreatment at 6 months)
  • Perception of quality of life(From baseline to posttreatment at 6 months)
  • CD4T and CD8T cells(From baseline to posttreatment at 6 months)
  • General psychopathology(From baseline to posttreatment at 6 months)
  • Treatment adherence(From baseline to posttreatment at 6 months)
  • Post-traumatic stress disorder(From baseline to posttreatment at 6 months)
  • Depression(From baseline to posttreatment at 6 months)

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Moreno Alcázar

PhD

Parc de Salut Mar

研究点 (1)

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