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临床试验/NCT03203902
NCT03203902已完成不适用

Comparative Effectiveness of Stress Management Using Psychoeducation Versus Therapeutic Touch for Formerly Homeless Adults With Mental Illness and Substance Use Histories

Columbia University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年9月10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
入组人数
20
试验地点
1
主要终点
Difference in Score on Perceived Stress Scale between pre- and post-intervention

研究概览

简要总结

Many formerly homeless adults with chronic mental illness experience treatment resistant symptoms for which pharmaceutical agents and cognitive behavioral therapy are not effective. Although formerly homeless adults with chronic mental illness typically receive medical and psychiatric services to manage their illness, chronic stress and post-traumatic stress disorder (PTSD) acquired from homelessness are difficult to resolve and many adults experience relapse that can result in housing loss. Therapeutic touch is a complementary and alternative treatment that has been shown to be effective at reducing stress, anxiety, and pain in a variety of diagnoses including cancer, cardiac disease, chronic pain syndromes, and PTSD in veterans. In this study the investigators aim to determine whether a 30-minute therapeutic touch session combined with a conventional 1-hour psychoeducation group delivered over 6 weeks can more effectively reduce stress compared to conventional psychoeducation alone. The ability to reduce stress levels and maintain emotional equilibrium is critical for this population to manage illness symptoms effectively and stave off the incidence of relapse, rehospitalizations, and housing loss.

详细描述

In 2015, approximately 600,000 people were reported to be homeless on any given night in the United States and 1.6 million used homeless shelter services. One-third of homeless adults who received shelter services were diagnosed with chronic mental illness (e.g., schizophrenia, bipolar disorder, major depression) and two-thirds had substance use disorders.

Once housed in supportive living residences, formerly homeless adults with mental illness commonly continue to experience high levels of stress, anxiety, depression, and post-traumatic stress disorder (PTSD), despite receiving medical and psychiatric services. Stress that is not sufficiently addressed can frequently lead to rehospitalizations and subsequent loss of housing. Although stress has been successfully treated with anti-anxiety pharmaceuticals, cognitive behavioral therapies, and support groups in adults in the larger population, formerly homeless adults with chronic mental illness tend to experience greater treatment resistance to such interventions or respond positively for short intervals and then relapse.

One nonpharmacological intervention that has gained increasing support in the last two decades is therapeutic touch. Therapeutic touch, also referred to as healing touch and touch therapy, is a complementary and alternative treatment in which practitioners seek to alleviate or reduce pain, stress, or anxiety through direct hand contact with a client's bio- or energy field. A bio- or energy field is defined in quantum physics as an interconnected web of energy that surrounds living organisms and may regulate emotional states and physical health. Although the existence of energy fields is increasingly accepted in the scientific community, the precise roles of and mechanisms through which energy fields work are not understood. While eastern health practitioners have for centuries used therapies addressing energy fields-for example, acupuncture, acupressure, Ayurveda, qi gong-western practitioners have only begun using such therapies in the last century. The most common western names for energy field therapy are therapeutic touch, healing touch, Reiki, and touch therapy-all of which have growing bodies of evidence supporting their effectiveness in the reduction of stress, anxiety, and pain in various diagnostic populations including cancer, cardiovascular disease, and chronic pain syndromes.

Although there is evidence that therapeutic touch can help reduce symptoms of PTSD in veterans, and stress and anxiety in cancer and cardiac patients, little information exists about whether therapeutic touch can reduce stress in formerly homeless adults with chronic mental illness. The ability to reduce stress in formerly homeless adults may help them manage illness symptoms better and prevent relapse for longer intervals.

In this comparative effectiveness study, the investigators will provide a conventional stress management psychoeducation group to 20 participants. Ten of these 20 participants will additionally receive 30 minutes of therapeutic touch delivered in a group setting. The remaining 10 participants will receive 30 minutes of sham therapeutic touch delivered in a group setting. Ten additional participants will be allocated to a control group with no intervention.

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 (Participant)

盲法说明

Participants receiving sham and authentic therapeutic touch will be masked.

入排标准

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

入选标准

  • •Current supportive housing resident
  • •History of homelessness
  • •History of mental illness

排除标准

  • •Severe behavioral or anger management disorder

研究组 & 干预措施

Psychoeducation and Sham Therapeutic Touch

Placebo Comparator

6-week psychoeducation group. The following 1-hour modules will be delivered:

Week 1: Anger Management and Conflict Negotiation Week 2: Meditation and Breathing Techniques Week 3: Nutrition Week 4: Exercise, Leisure, and Recreation Week 5: Sleep Week 6: Wellness Recovery Action Plan (WRAP)

Directly after the psychoeducation group is completed, 30-minute sham therapeutic touch will be administered.

干预措施: Psychoeducation and Therapeutic Touch (Other)

Psychoeducation and Therapeutic Touch

Active Comparator

6-week psychoeducation group. The following 1-hour modules will be delivered:

Week 1: Anger Management and Conflict Negotiation Week 2: Meditation and Breathing Techniques Week 3: Nutrition Week 4: Exercise, Leisure, and Recreation Week 5: Sleep Week 6: Wellness Recovery Action Plan (WRAP)

Directly after the psychoeducation group is completed, 30-minute therapeutic touch will be administered.

干预措施: Psychoeducation and Therapeutic Touch (Other)

Control

No Intervention

No intervention

结局指标

主要结局

Difference in Score on Perceived Stress Scale between pre- and post-intervention

时间窗: baseline and 7 weeks

5-point, 10-item Likert scale that takes approximately 5 minutes to complete

次要结局

  • Difference in Score on World Health Quality of Life Scale between pre- and post-intervention(baseline and 7 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharon Gutman

Professor of Rehabilitation and Regenerative Medicine

Columbia University

研究点 (1)

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