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临床试验/NCT03293797
NCT03293797Unknown不适用

Improving Access to Quality Mental Healthcare Through Innovations in Psychotherapy: A Pilot Study of a Novel, Ultra-Brief Intervention to Reduce Depressive and Anxious Symptoms

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
2
主要终点
Change from Baseline Anxiety Symptoms at 5 Week

研究概览

简要总结

Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately, patients often face barriers to accessing mental health care, particularly psychotherapeutic interventions, including long wait-times and demanding therapeutic protocols. For instance, Mindfulness-Based Therapy (MBT) has demonstrated effectiveness at decreasing symptoms of depression and anxiety, and improving wellbeing; however, 'traditional' MBT can demand over 30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to care. A pilot, uncontrolled study conducted at Sunnybrook illustrated the potential feasibility / efficaciousness of a novel abbreviated MBT in improving hospital staff wellbeing. The goal of this controlled study is to further test feasibility and acceptability of this intervention to reduce depressive / anxious symptoms, reduce stress and improve wellbeing in outpatient mood/anxiety patients. If efficacious, this Abbreviated MBT could reduce barriers to accessing mental health care.

详细描述

BACKGROUND: ABBREVIATED-MINDFULNESS BASED THERAPY (A-MBT)

By the age of 40, 1 in 2 Canadians have been or are presently experiencing mental health issues. In particular, anxiety and mood disorders are the most prevalent lifetime mental health illnesses, affecting 11.6% of the population. Mindfulness based treatments (MBTs) have strong evidence for improving patient wellness through reduction of anxiety and mood symptoms in clinical populations. Although efficacious, 'traditional' MBTs are very demanding in terms of time and homework a relevant factor when considering the recent calls for waittime reductions in psychotherapeutic mental health services. These programs take 30+ hours (including 2-3 hr. weekly sessions across 8 weeks, plus a 1-day retreat) and expect 45-60 min./day of meditation homework. The goal of this project is to test the effectiveness of an abbreviated MBI in reducing anxiety and/or mood disturbances and improving patient well-being.

MBTs use a non-stigmatizing approach, combining secularized eastern meditative practices with western psychological advances to improve stress-management and self-care. Participants learn to generate less distress, engage more positively and fully in their lives and experiences, and respond more adaptively to challenges instead of reacting in automatic and unhelpful ways. Participants in MBI often describe the intervention as transformative. Professional experience and new insights into MBTs suggest that these 'tradition' treatment programs can be further abbreviated to develop a effective and accessible clinical intervention. This abbreviated MBT has been developed, which if effective will curtail wait-times and increase patient treatment annually.

RATIONAL & HYPOTHESIS/RESEARCH QUESTION Rational

Patients face barriers to accessing psychotherapy, including long wait-times and/or protocols that are too demanding for many patients. Traditional Mindfulness-Based Therapies (MBTs) are highly studied and well-recognized treatment options to reduce anxiety and mood symptoms - demonstrating repeated efficacy in clinical populations. However, the high demands of clinical time and homework are a barrier to many patients. Further, longer clinical interventions mean fewer patients being treated per hour of clinician's time, and therefore longer wait-times. Clinical experience and new insights into MBTs suggest that these 'tradition' treatment programs can be further abbreviated to develop an effective and more accessible therapy. If this Abbreviated MBT is demonstrated to be clinically effective, it can reduce barriers to mental health care by reaching more patients in a more timely fashion.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Consenting mood and anxiety outpatients referred to Dr. Selchen in the Sunnybrook Mindfulness-Based Therapy Clinic
  • Due to the nature of the assessment procedures, which include English-language self- report questionnaires and scales, ability to communicate in written and spoken English is an inclusion criterion

排除标准

  • Patients who have active or recent (within 3 months) substance abuse/dependence, a history of dementia, untreated posttraumatic stress symptoms, active psychotic or manic symptoms, recent suicide attempt/active suicidality, or current self-injurious behaviour
  • Previously completed a course (≥ 8 weeks) of a Mindfulness-Based Therapy within the last 3 years

结局指标

主要结局

Change from Baseline Anxiety Symptoms at 5 Week

时间窗: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)

Scale used to measure Anxiety Symptoms: Generalized Anxiety Disorder 7-item (GAD-7)

Change from Baseline Depressive Symptoms at 5 Week

时间窗: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)

Scale used to measure Depressive Symptoms: Patient Health Questionnaire 9-item (PHQ-9)

次要结局

  • Change from Baseline Mental Wellbeing at 5 Week(Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5))
  • Change from Baseline Self-Compassion at 5 Week(Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)])

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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