Massage Therapy for Generalized Anxiety Disorder

Overseen By Eric Garland, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Psychotropics, others

Disqualifiers: Nicotine, Pregnancy, PTSD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of touch therapies, Swedish massage and light touch therapy, affect the brain and anxiety symptoms in people with generalized anxiety disorder (GAD). Participants will be randomly assigned to one of the two therapy groups, receiving sessions twice a week for six weeks. Researchers will use brain scans to observe changes in brain activity and will have participants complete questionnaires about their anxiety, stress, and depression. Suitable candidates include those with a primary diagnosis of GAD who have been off certain medications for at least two weeks or on a stable dose for six weeks. As an unphased trial, this study offers a unique opportunity to contribute to understanding how touch therapies can impact anxiety.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Swedish massage therapy is generally well-tolerated by most people, helping to reduce anxiety and lower stress levels. Many individuals feel relaxed and comfortable during and after sessions. Side effects are rare and usually mild, such as slight soreness or tiredness.

Light touch therapy is also considered safe, involving gently placing hands on the body. Like Swedish massage, it is non-invasive and usually pleasant. Participants in studies have not reported any significant negative effects.

Both treatments appear safe based on existing research. They focus on relaxation and stress relief, making them suitable for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Generalized Anxiety Disorder (GAD), which often involve medication like SSRIs or cognitive behavioral therapy, massage therapy offers a non-pharmacological approach. Researchers are excited about Swedish Massage Therapy (SMT) because it employs specific techniques like effleurage and petrissage, which may help reduce anxiety through physical relaxation and stress relief. Additionally, the Light Touch Control method provides a unique comparison to isolate the mechanical benefits of massage, helping researchers understand the full impact of touch on anxiety. This trial could reveal new insights into how different types of touch therapy can effectively manage GAD symptoms without medication.

What evidence suggests that this trial's treatments could be effective for generalized anxiety disorder?

Research has shown that Swedish massage therapy, one of the treatments in this trial, can help reduce anxiety symptoms. In one study, participants who received Swedish massage therapy twice a week for six weeks experienced a significant decrease in anxiety. Other studies have found that it also lowers stress hormones like cortisol. Swedish massage therapy is considered an effective short-term treatment for generalized anxiety disorder (GAD). Meanwhile, Light Touch Therapy, another treatment arm in this trial, is often used in studies to compare with the benefits of Swedish massage, although limited data exists on its effectiveness for anxiety. ^{2 6 7 8 9}

Who Is on the Research Team?

Mark H Rapaport, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Light Touch Therapy
• Swedish Massage Therapy

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.

How Is the Trial Designed?

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+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7770051/

Six versus Twelve Weeks of Swedish Massage Therapy for ... These preliminary findings suggest that the majority of benefit in symptom reduction occurs in the first six weeks and that six weeks of twice- ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1360859222001565

A preliminary descriptive report of the longevity ... In 2016, our group demonstrated that 6 weeks of twice-weekly Swedish massage therapy (SMT) was clinically effective in decreasing symptoms of anxiety and ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT01337713?term=Therapeutic+massage&cond=Generalized+Anxiety+Disorder&draw=2&rank=2

Efficacy of Massage Therapy in the Treatment ... Preliminary studies suggest that massage therapy decreases symptoms of anxiety and depression, and lowers salivary cortisol levels in a wide array of childhood ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27464321/

Acute Swedish Massage Monotherapy Successfully ... - PubMed This first monotherapy trial suggests that a complementary and alternative manual therapy, SMT, is an effective acute treatment for GAD.

5. bodyworkmovementtherapies.com bodyworkmovementtherapies.com/article/S1360-8592(22)00156-5/pdf

A preliminary descriptive report of the longevity of ... One case series reports that patients with GAD benefited from Swedish Massage therapy (SMT) (Billhult and. Maatta, 2009). However, a randomized controlled trial ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2922919/

Effectiveness of Therapeutic Massage for Generalized ... This study evaluates the effectiveness of therapeutic massage for persons with generalized anxiety disorder (GAD).

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36775516/

A preliminary descriptive report of the longevity ... The primary outcome measure was reduction in Hamilton Anxiety Rating Scale (HAM-A) scores after six weeks of SMT versus LT. Qualifying participants received a ...

8. psychiatrist.com psychiatrist.com/jcp/massage-monotherapy-remediates-symptoms-of-anxiety/

A Proof-of-Concept, Randomized Controlled Study Further study to replicate and extend our findings by comparing Swedish massage therapy to accepted treatments for GAD is warranted.

9. withpower.com withpower.com/trial/phase-anxiety-disorders-4-2024-68ce6

Massage Therapy for Generalized Anxiety Disorder This clinical trial will compare the effects of Swedish massage or light touch therapy on brain activity and symptoms of anxiety.