Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD) (GAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01337713
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : July 27, 2017
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Mark H. Rapaport, Emory University

April 15, 2011
April 19, 2011
July 27, 2017
September 2010
January 2014   (Final data collection date for primary outcome measure)
Hamilton Anxiety Scale [ Time Frame: 25 times over an average of 13 weeks ]
Not Provided
Complete list of historical versions of study NCT01337713 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)
Efficacy of Massage and Light Touch Therapy for the Treatment of Generalized Anxiety Disorder

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.

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Other: Swedish Massage
    Swedish massage, 45 minutes, 2 x per week for 6 weeks
  • Other: Light Touch
    Light touch, 45 minutes, 2 x week for 6 weeks
  • Experimental: Swedish Massage
    Intervention: Other: Swedish Massage
  • Sham Comparator: Light Touch
    Intervention: Other: Light Touch
Rapaport MH, Schettler P, Larson ER, Edwards SA, Dunlop BW, Rakofsky JJ, Kinkead B. Acute Swedish Massage Monotherapy Successfully Remediates Symptoms of Generalized Anxiety Disorder: A Proof-of-Concept, Randomized Controlled Study. J Clin Psychiatry. 2016 Jul;77(7):e883-91. doi: 10.4088/JCP.15m10151.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2014
January 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
7R21AT004208-02 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Mark H. Rapaport, Emory University
Emory University
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Mark H Rapaport, M.D. Emory University
Emory University
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP