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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Swedish Massage
Light Touch
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Anxiety, GAD, Massage

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Swedish Massage

Light Touch

Arm Description

Outcomes

Primary Outcome Measures

Hamilton Anxiety Scale

Secondary Outcome Measures

Full Information

First Posted
April 15, 2011
Last Updated
July 25, 2017
Sponsor
Emory University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01337713
Brief Title
Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)
Acronym
GAD
Official Title
Efficacy of Massage and Light Touch Therapy for the Treatment of Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Anxiety, GAD, Massage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Swedish Massage
Arm Type
Experimental
Arm Title
Light Touch
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Swedish Massage
Intervention Description
Swedish massage, 45 minutes, 2 x per week for 6 weeks
Intervention Type
Other
Intervention Name(s)
Light Touch
Intervention Description
Light touch, 45 minutes, 2 x week for 6 weeks
Primary Outcome Measure Information:
Title
Hamilton Anxiety Scale
Time Frame
25 times over an average of 13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark H Rapaport, M.D.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University, Department of Psychiatry
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27464321
Citation
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.
Results Reference
derived

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

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