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
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Anxiety, GAD, Massage
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
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
NCT ID
NCT01337713
First Posted
April 15, 2011
Last Updated
July 25, 2017
Sponsor
Emory University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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
Learn more about this trial
Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)
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