Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)
| Tracking Information | |||||
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| First Received Date ICMJE | April 15, 2011 | ||||
| Last Updated Date | April 2, 2013 | ||||
| Start Date ICMJE | September 2010 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Hamilton Anxiety Scale [ Time Frame: 25 times over an average of 13 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01337713 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD) | ||||
| Official Title ICMJE | Efficacy of Massage and Light Touch Therapy for the Treatment of Generalized Anxiety Disorder | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Generalized Anxiety Disorder | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | April 2014 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01337713 | ||||
| Other Study ID Numbers ICMJE | 7R21AT004208-02 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Mark H. Rapaport, Emory University | ||||
| Study Sponsor ICMJE | Emory University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Emory University | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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