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临床试验/NCT01337713
NCT01337713已完成不适用

Efficacy of Massage and Light Touch Therapy for the Treatment of Generalized Anxiety Disorder

Emory University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年9月最近更新:
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
40
试验地点
2
主要终点
Hamilton Anxiety Scale

研究概览

简要总结

There is an impressive and growing body of data suggesting that massage therapy is effective in decreasing some symptoms of pathological conditions as well as facilitating growth, reducing pain, increasing alertness, diminishing symptoms of depression and anxiety, and enhancing immune function. Preliminary studies suggest that massage therapy decreases symptoms of anxiety and depression, and lowers salivary cortisol levels in a wide array of childhood and adult neuropsychiatric disorders including post-traumatic stress disorder, attention-deficit-disorder hyperactivity, depression, bulimia and anorexia-nervosa. Generalized Anxiety Disorder (GAD) is characterized by the presence of a constellation of signs and symptoms for at least 6 months in duration, with some type of functional disability or decrease in quality of life. The signs and symptoms of GAD include a myriad of somatic symptoms including muscle tension, headaches, backaches, fatigue, restlessness, insomnia, as well as psychological feelings of worry, anxiety, and feeling overwhelmed. Both pharmacotherapy and psychotherapy are effective in decreasing the signs and symptoms of GAD. Unfortunately, the vast majority of patients with GAD never receive adequate pharmacotherapy or psychotherapy. Therefore, the development of a complementary and alternative therapy that has demonstrated efficacy for GAD might be well received by patients.

This study's goals are to investigate the efficacy of Swedish massage therapy vs. light touch therapy and better understand the biological effects of massage in patients with anxiety. Qualified participants will be randomly assigned to one of two groups in which they will receive Swedish massage therapy twice per week for 12 weeks or Light Touch therapy twice per week for 6 weeks followed by Swedish massage therapy twice per week for the next 6 weeks. The total length of the study is 13 weeks, which includes a screening visit that takes about 3 hours and two therapy visits per week for 12 weeks that last about 1 hour each. Blood and urine will be collected at three of the visits. Compensation is up to $400 for completing the entire study.

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
Double (Investigator, Outcomes Assessor)

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

  • Age 18 to 65 years old
  • Able to read and understand English
  • Medically healthy as demonstrated by a normal history and physical examination
  • Meet criteria for a primary diagnosis of current GAD as demonstrated by a structured clinical interview for DSM-IV (SCID),
  • HAM-A score of greater than 14
  • Normal blood work and urinalysis (CBC, Renal, Hepatic, Tox Screen)

排除标准

  • Individuals who lack a capacity to consent, or whose capacity to provide consent is questionable to the investigator
  • Current suicidal ideation (core of 3 or more on the HAM-D suicide item)
  • Current diagnosis of schizophrenia
  • Current diagnosis of bipolar disorder
  • Current diagnosis of borderline personality disorder
  • Comorbid secondary disorder diagnosis of OCD
  • Current illicit drug use
  • Excessive regular use of alcohol (more than two 5-oz glasses of wine or equivalents/day) or a history of binge drinking (more than 7 drinks/24 hour period) within the last six months
  • Regular or "PRN" psychotropic medication use
  • Current participation in psychotherapy or cognitive behavioral therapy
  • Pregnancy
  • Shift work schedule
  • Active dieting for weight loss
  • Active medical problems
  • Fibromyalgia (on daily medication)
  • Arthritis requiring daily meds and unable to abstain from meds for duration of study period

研究组 & 干预措施

Swedish Massage

Experimental

干预措施: Swedish Massage (Other)

Light Touch

Sham Comparator

干预措施: Light Touch (Other)

结局指标

主要结局

Hamilton Anxiety Scale

时间窗: 25 times over an average of 13 weeks

次要结局

未报告次要终点

研究者

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

Mark H. Rapaport

Professor and Chair

Emory University

研究点 (2)

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