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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mark H. Rapaport, Emory University
ClinicalTrials.gov Identifier:
NCT01337713
First received: April 15, 2011
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Generalized Anxiety Disorder
Other: Swedish Massage
Other: Light Touch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Massage and Light Touch Therapy for the Treatment of Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Hamilton Anxiety Scale [ Time Frame: 25 times over an average of 13 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Swedish Massage Other: Swedish Massage
Swedish massage, 45 minutes, 2 x per week for 6 weeks
Sham Comparator: Light Touch Other: Light Touch
Light touch, 45 minutes, 2 x week for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337713

Locations
United States, Georgia
Emory University, Department of Psychiatry
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Mark H Rapaport, M.D. Emory University
  More Information

No publications provided

Responsible Party: Mark H. Rapaport, Professor and Chair, Emory University
ClinicalTrials.gov Identifier: NCT01337713     History of Changes
Other Study ID Numbers: IRB00052054, 7R21AT004208-02
Study First Received: April 15, 2011
Last Updated: November 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Emory University:
Anxiety, GAD, Massage

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014