Massage Therapy for Generalized Anxiety Disorder

Overseen by Mark H Rapaport, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Utah

Must not be taking: Psychotropics, others

Disqualifiers: Nicotine, Pregnancy, PTSD, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This clinical trial will compare the effects of Swedish massage or light touch therapy on brain activity and symptoms of anxiety. This is a randomized research study and subjects will be randomized into one of two study touch intervention groups, and will have an equal chance of being placed in one of the groups: 1. Swedish massage therapy twice per week for 6 weeks. 2. Light touch therapy twice per week for 6 weeks. The Primary Objective is to identify brain networks activated by touch interventions using fMRI brain imaging in subjects with generalized anxiety disorder. Subjects will undergo two fMRI scanning sessions (one before and one after) twice per week for 6 weeks of touch intervention. Subjects will also be asked to complete questionnaires on anxiety, stress and depression.

Will I have to stop taking my current medications?

You don't have to stop your current medications if you've been on a stable dose for at least 6 weeks before starting the trial. If you're not on a stable dose, you need to be off psychotropic medications for at least 2 weeks before joining.

What data supports the effectiveness of the treatment Light Touch Therapy, Light Touch Therapy, LT, Swedish Massage Therapy, SMT, Manual Therapy, Therapeutic Massage for Generalized Anxiety Disorder?

Research shows that Swedish Massage Therapy (SMT) can effectively reduce symptoms of Generalized Anxiety Disorder (GAD), with significant improvements seen in the first six weeks of treatment. Additionally, therapeutic touch has been found to reduce anxiety and improve mood in healthy women, suggesting potential benefits for anxiety management. ^{1 2 3 4 5}

Is massage therapy safe for humans?

Massage therapy, including techniques like Swedish Massage and Therapeutic Touch, is generally considered safe and is widely used to help reduce stress, anxiety, and pain. It is often practiced in medical settings and has been shown to have positive effects on various conditions. ^{1 2 5 6 7}

How is massage therapy different from other treatments for generalized anxiety disorder?

Massage therapy, including Swedish Massage Therapy and Light Touch Therapy, offers a non-drug approach to treating generalized anxiety disorder by promoting relaxation and reducing anxiety through physical touch, which can enhance self-confidence and provide a sense of unconditional attention. Unlike traditional treatments like cognitive behavioral therapy or medication, massage therapy focuses on the physical experience of relaxation and may be preferred by those seeking alternative methods. ^{1 2 3 4 8}

Research Team

Mark H Rapaport, MD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for individuals with Generalized Anxiety Disorder (GAD). Participants will receive either Swedish massage therapy or light touch therapy twice a week for six weeks. They must be willing to undergo fMRI scans and complete questionnaires about their anxiety, stress, and depression levels.

Inclusion Criteria

I have been diagnosed with Generalized Anxiety Disorder.

Hamilton Rating Scale for Anxiety (HAM-A) score of 15 or higher

Subjects must be able to comply with the research protocol

Exclusion Criteria

Meets criteria for current suicidal or homicidal ideation

Current participation in another research study

History of head injury or neurological disorder impacting data or study completion

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Swedish massage therapy or light touch therapy twice per week for 6 weeks

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Light Touch Therapy (Behavioural Intervention)
• Swedish Massage Therapy (Behavioural Intervention)

Trial Overview The study aims to compare the effects of Swedish massage therapy versus light touch therapy on brain activity and anxiety symptoms in GAD patients. It involves random assignment to one of the two therapies and includes before-and-after brain imaging as well as regular assessments.

Participant Groups

Group I: Swedish Massage Therapy Experimental Treatment 1 Intervention

The therapist uses non-aromatic cream to facilitate making long strokes over the body. Swedish massage is done with the subject covered by a sheet, a technique called "draping." One part of the body is uncovered, massaged, and then re-draped before moving to another part. The primary techniques used in the research protocol therapy are effleurage, petrissage, kneading, tapotement and thumb friction. These techniques are performed in a very precise, carefully elaborated manner. The session starts with the subject fully draped in a prone position on the massage table and after approximately 22 minutes the subject is instructed to turn to the supine position. Finally, the therapist moves to the head area of the subject, begins working on the shoulders, neck and head using effleurage and thumb friction, and concludes by using light tapotement on the head. The total time for the entire massage is 45 minutes. Subjects randomized to SMT will undergo 2/week for a total of 6 weeks.

Group II: Light Touch Control Active Control 1 Intervention

The Light Touch Control protocol entails the same duration and sequence of procedures as the massage protocol, except that the therapist employs only light-touch hand placement on the subject's body. This condition isolates the effect of the mechanical intervention of SMT. Subjects randomized to LT will undergo 2/week for a total of 6 weeks.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Dr. Amy P. Patterson

National Center for Complementary and Integrative Health (NCCIH)

Chief Medical Officer

MD from Johns Hopkins University

Dr. Helene Langevin

National Center for Complementary and Integrative Health (NCCIH)

Chief Executive Officer since 2018

MD from McGill University

Findings from Research

A study involving 47 participants with Generalized Anxiety Disorder (GAD) found that Swedish Massage Therapy (SMT) significantly reduced anxiety symptoms, with 47% of subjects reporting no return of symptoms up to one year after treatment.

The benefits of SMT were sustained for many participants, indicating that it could be a viable non-traditional treatment option for GAD, especially since no significant differences were found between those receiving different durations of SMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary descriptive report of the longevity of the effects of Swedish Massage therapy for subjects with Generalized Anxiety Disorder. Rapaport, MH., Schettler, PJ., Larson, ER., et al.[2023]

A proof-of-concept study involving 47 untreated subjects with generalized anxiety disorder (GAD) found that Swedish massage therapy (SMT) significantly reduced anxiety levels compared to a light touch control over 6 weeks, with a notable difference in Hamilton Anxiety Rating Scale (HARS) scores.

The effectiveness of SMT became apparent by the end of week 3, suggesting that it can serve as a viable nontraditional treatment option for GAD, with a significant reduction in anxiety symptoms observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Swedish Massage Monotherapy Successfully Remediates Symptoms of Generalized Anxiety Disorder: A Proof-of-Concept, Randomized Controlled Study. Rapaport, MH., Schettler, P., Larson, ER., et al.[2020]

A study on the effects of six weeks of twice-weekly Swedish Massage Therapy (SMT) showed significant reductions in anxiety symptoms, as measured by the Hamilton Anxiety Rating Scale (HAM-A), indicating its efficacy for treating Generalized Anxiety Disorder.

While additional six weeks of SMT continued to reduce anxiety scores, the most significant improvements were observed during the first six weeks, suggesting that this duration may be sufficient for most patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six versus twelve weeks of Swedish massage therapy for generalized anxiety disorder: Preliminary findings. Rapaport, MH., Schettler, PJ., Larson, ER., et al.[2023]

In a study of 68 individuals with generalized anxiety disorder (GAD), therapeutic massage did not show superior effectiveness compared to control treatments like thermotherapy and relaxing room therapy, with all groups experiencing significant reductions in anxiety after 10 sessions over 12 weeks.

Despite the lack of difference between treatments, all participants maintained their anxiety improvements at a 26-week follow-up, suggesting that relaxation techniques, regardless of type, can provide clinically important benefits for managing GAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of therapeutic massage for generalized anxiety disorder: a randomized controlled trial. Sherman, KJ., Ludman, EJ., Cook, AJ., et al.[2021]

Therapeutic touch (TT) significantly improved mood in 41 healthy female volunteers, reducing tension, confusion, and anxiety while increasing vigor over three sessions.

Biochemical analysis showed that TT led to a significant decrease in nitric oxide levels, suggesting a potential mechanism for its calming effects, which could be beneficial for cancer patients experiencing distress during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of therapeutic touch on biochemical and mood indicators in women. Lafreniere, KD., Mutus, B., Cameron, S., et al.[2015]

HT (Healing Touch) and TT (Therapeutic Touch) are safe and effective adjunct therapies used in pediatric hospitals to reduce stress, anxiety, and pain in patients.

While practitioners and patients report improved well-being during and after these treatments, further research is needed to understand their mechanisms, optimal usage, and overall cost-effectiveness compared to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating children with therapeutic and healing touch. Kemper, KJ., Kelly, EA.[2019]

Massage therapy has shown beneficial effects for a wide range of conditions, including prenatal depression, pain syndromes, and immune conditions, often outperforming control groups in studies.

The positive effects of massage therapy may be linked to its ability to stimulate pressure receptors, which enhances vagal activity and lowers cortisol levels, suggesting a physiological mechanism behind its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage therapy research review. Field, T.[2022]

Massage therapy may provide significant benefits for patients with Generalized Anxiety Disorder (GAD), as evidenced by a study involving eight patients who reported reduced anxiety and increased self-confidence during treatment.

Participants experienced a sense of relaxation and unconditional attention during massages, suggesting that this therapeutic approach could enhance traditional treatments like cognitive behavioral therapy and medication for managing GAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light pressure massage for patients with severe anxiety. Billhult, A., Määttä, S.[2009]

References

1. United States pubmed.ncbi.nlm.nih.gov

A preliminary descriptive report of the longevity of the effects of Swedish Massage therapy for subjects with Generalized Anxiety Disorder. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Acute Swedish Massage Monotherapy Successfully Remediates Symptoms of Generalized Anxiety Disorder: A Proof-of-Concept, Randomized Controlled Study. [2020]

3. Scotland pubmed.ncbi.nlm.nih.gov

Six versus twelve weeks of Swedish massage therapy for generalized anxiety disorder: Preliminary findings. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of therapeutic massage for generalized anxiety disorder: a randomized controlled trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of therapeutic touch on biochemical and mood indicators in women. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Treating children with therapeutic and healing touch. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Massage therapy research review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Light pressure massage for patients with severe anxiety. [2009]