Generalized Anxiety DisorderGADNCT01337713
Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)
A study testing Swedish Massage and Light Touch in people with Generalized Anxiety Disorder, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Swedish Massage and Light Touch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University, Department of Psychiatry
Atlanta, Georgia, 30322
About this study
Official title: 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Swedish Massage, Light Touch
- Keywords
- Anxiety, GAD, Massage
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swedish MassageOther
Swedish massage, 45 minutes, 2 x per week for 6 weeks
Light TouchOther
Light touch, 45 minutes, 2 x week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Swedish Massage | Experimental | Not described Receives: Other: Swedish Massage |
| Light Touch | Sham comparator | Not described Receives: Other: Light Touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Scale
Measured: 25 times over an average of 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startSep 2010
- Primary completionJan 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Mark H. Rapaport, Emory University
- Investigators
- Mark H Rapaport, M.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337713
- Sponsor's protocol ID
- IRB00052054
- Other IDs
- 7R21AT004208-02
- Acronym
- GAD
- Status last verified
- Jul 2017
- First submitted
- 15 Apr 2011
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27464321
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Massage and Light Touch Therapy for the Treatment of Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT01337713
- Acronym / sponsor ID
- GAD / IRB00052054
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Anxiety, GAD, Massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swedish Massage | Experimental | Other: Swedish Massage |
| Light Touch | Sham comparator | Other: Light Touch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swedish MassageSwedish massage, 45 minutes, 2 x per week for 6 weeks | Other | Swedish Massage |
| Light TouchLight touch, 45 minutes, 2 x week for 6 weeks | Other | Light Touch |
Primary outcome
Hamilton Anxiety Scale
Time frame: 25 times over an average of 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Derived from this study: PubMed 27464321Rapaport 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark H Rapaport, M.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swedish Massage and Light Touch in people with Generalized Anxiety Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Scale (time frame: 25 times over an average of 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01337713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.