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临床试验/NCT02122978
NCT02122978Unknown不适用

Comparing Mindfulness Based Cognitive Therapy and Mindfulness Based Self-compassion Therapy: Understanding What Works Psychologically and Physiologically in a Randomized Study in Dermatology

St Vincent's University Hospital, Ireland2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
94
试验地点
2
主要终点
Change in immunological markers

研究概览

简要总结

Increasing research evidence supports the effectiveness of mindfulness based interventions; however, the exact mechanisms of change are poorly understood. Some evidence proposes that self-compassion is an important mechanism of change in the effectiveness of mindfulness based interventions. The current research will evaluate and compare the effectiveness of two mindfulness meditation approaches; Mindfulness Based Cognitive Therapy (MBCT) and Mindfulness based Self-compassion Therapy (MBSCT), for individuals with psoriasis, a skin condition commonly associated with stress. Blood analyses will be conducted to assess and compare the impact of the interventions on the immune system. Self-report questionnaires will explore participants' psychological functioning (e.g. self-compassion, depression, anxiety, worry). This study will also examine whether a relationship exists between immune functioning and psychological factors. An audio-guided MBSCT programme will be piloted, with a view to trialling as a more cost-effective alternative to traditional mindfulness interventions. Findings will enable us to design more effective interventions in the future, and yield clear results regarding the existence of a definite link between immunological functioning and psychological functioning.

The main research hypothesis is that participants who complete a mindfulness based intervention will experience significantly greater psychological well-being, symptom reduction, and greater changes in telomerase and cytokine activity than individuals who only receive treatment as usual for their psoriasis.

详细描述

The proposed research is a randomized, multi-site, blinded comparative study of mindfulness-based cognitive therapy (MBCT), Mindfulness Based Self-compassion Therapy (MBSCT), minimal-contact MBSCT, and treatment as usual (TAU) in patients with psoriasis.

Recruitment commenced in November 2013 and continued until March 2014. Participants were recruited via the Department of Dermatology in St. Vincent's University Hospital. During weekly dermatology clinics eligible participants were identified by medical members of the Dermatology team and on expression of interest were referred to an Assistant Psychologist for recruitment purposes. In addition participants were also recruited via an advertisement placed in a national newspaper.

Eligible patients will be randomly assigned to TAU (n=25), MBCT (n=25), MBSCT (n=25), or audio-guided MBSCT (n=25).

At Time 1 (pre intervention), participants will be required to give blood (a 50ml sample, i.e., roughly 10 teaspoons), and complete self-report measures on the same day as beginning the mindfulness programme. As it has previously been indicated that cells may be sensitive to sudden changes in stress, mood and time of day (Epel, 2012), blood samples will always be taken after completing the self-report measures and at a relatively standardized time, e.g., between 3-5pm. Care will be taken to ensure that conditions are relaxed across all participants, and a 10 minute rest period between completing the questionnaires and giving blood will be enforced. Bloods can be kept at room temperate for up to 24 hours and then prepared for storage below 60 degrees Celsius until PBMC analysis is to be conducted after all samples have been collected at Time 1 (post intervention).

At Time 2, six-months and twelve-months follow-up, participants will again be required to give 50ml of blood and complete all self-report measures via an identical protocol, and analysis will be conducted again accordingly. Telomerase will be assessed using a TRAPeze EXCEL Telomerase Detection Kit. This will be complemented by flow cytometry analysis of telomere length. Serum cytokines before and after treatment will be examined by ELISA. This should give an indication of the effect of treatment on systemic inflammation. We will also examine the ability of PBMC from patients to produce proinflammatory cytokines, including IL-6, TNF, IL-1, and others associated with anxiety and depression. PBMC will be activated with innate stimulus such as LPS/zymosan. The production of cytokines will be determined by ELISA. Highly sensitive CRP is also a marker for psoriasis and will be assessed by ELISA to give an indication of overall inflammation. In regards to self-report measures, the following psychological scales will be used:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

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

入选标准

  • adults over 18 years
  • diagnosis of mild to severe psoriasis

排除标准

  • extraneous health issues which may influence immunological activity
  • Participants deemed unsuitable for MBCT or MBSCT after a psychological assessment
  • previous participation in a formal 8-week mindfulness programme (e.g., MBCT, MBSR).

结局指标

主要结局

Change in immunological markers

时间窗: 14 months

Telomerase, Cytokines, C Reactive Protein will be measured in blood at 4 time points.

Psoriasis symptom control

时间窗: 14 months

Measured by Psoriasis Area \& Severity Index (PASI) and drug dose reduction (if applicable)

Psychological Well-Being

时间窗: 14 months

As measured by: Hospital Anxiety and Depression Scale Penn State Worry Questionnaire Fears of Compassion Scales Five Facets of Mindfulness Questionnaire

Quality of Life

时间窗: 14 months

Measured by WHO QoL index and Dermatology Life Quality Index.

次要结局

未报告次要终点

研究者

发起方
St Vincent's University Hospital, Ireland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Paul D'Alton

Dr. Paul D'Alton

St Vincent's University Hospital, Ireland

研究点 (2)

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