Efficacy Study of Abdominal Massage Therapy to Treat Generalized Anxiety Disorder of Deficiency of Both Heart and Spleen Type

NCT02186366 | Unknown

• 1 other identifier: TECF 20120210
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Generalized Anxiety Disorder (GAD) is characterized by the presence of persistent worry or fear of no explicit object and fixed content, or things that might occur in real life，which not corresponds with the realities. Patients with GAD may occur a series of somatic symptoms including muscle tension, backaches, headaches, fatigue, insomnia, restlessness, as well as psychological feelings of anxiety, worry and feeling overwhelmed. And it always brings some type of functional disability or decrease in quality of life. GAD is treated by Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin, Norepinephrine Reuptake Inhibitors(SNRI) and 5-ht1a receptor agonists as regular medication which have the definite effects. But, some adverse reaction of SSRIs or SNRI leads to the compliance of taking medicine of patients with GAD. There is an impressive data suggesting that Abdominal Massage Therapy is effective in decreasing some symptoms of somatic symptoms and psychological feelings. This study is designed as a parallel group, positive control, non-inferiority study. It will recruit 140 cases of generalized anxiety disorder of deficiency of both heart and spleen type. Both the treatment group and the control group will be randomly assigned 70 cases. Patients in the treatment group will be treated by Abdominal Massage for 6 weeks，and the control group by buspirone . The total study includes 4 views that are respectively before the treatment，after 3 weeks treatment, after the whole treatment , and 3 months after the whole treatment. At all of the 4 views, all participants will be estimated the scores of Hamilton Depression Scale(HAMD) ,self-rating anxiety scale(SAS), and Quality of life assessment scale. At the second, third and the forth views, all participants will be estimated Clinical Global Impression ( CGI). At the first and the third views, all participants will be collected the data of content of hydroxytryptamine（5-HT）, Norepinephrine and total cortisol in blood plasma, and of blood stream speed, vascular resistance index and pulsatility index of middle cerebral artery （MCA）, anterior cerebral artery（ACA）, posterior cerebral artery （PCA） and basilar artery（BA）. This study aims to investigate the efficacy of Abdominal Massage Therapy vs. buspirone, and discover the correlation between these scales and these objective indicators.

Conditions

Anxiety Disorders

Keywords

Anxiety Disorders, Massage Therapy, Treatment Efficacy

Outcome Measures

Primary Outcomes (1)

• reductive rate of Hamilton Depression Scale（ HAMD reductive rate）

  We will estimate the scores of the Hamilton Depression Scale of participants at baseline and post- 6week intervention，then calculate the HAMD reductive rate according to the following formula：HAMD reductive rate=（scores of HAMD at baseline - scores of HAMD at post- 6week intervention ）/ scores of HAMD at baseline×100%

  baseline and post- 6week intervention

Secondary Outcomes (4)

• Scores of Hamilton Depression Scale(HAMD)

  baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention

• Scores of self-rating anxiety scale( SAS)

  baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention

• Scores of Quality of life assessment scale

  baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention

• Scores of Clinical Global Impression

  post- 3week intervention and post- 6week intervention and post-3month after 6- week intervention

Other Outcomes (6)

• content of 5-HT in blood plasma

  baseline and post- 6week intervention

• content of Norepinephrine in blood plasma

  baseline and post- 6week intervention

• content of total cortisol in blood plasma

  baseline and post- 6week intervention

Study Arms (2)

Abdominal Massage Therapy

EXPERIMENTAL

Abdominal Massage Therapy , 30 minutes, three times one week for 6 weeks

Drug: Buspirone

Buspirone

ACTIVE COMPARATOR

Buspirone by mouth 5mg three times per day for 6week

Other: Abdominal Massage Therapy

Interventions

Abdominal Massage Therapy OTHER

Abdominal Massage Therapy , 30 minutes, three times one week for 6 weeks. If the subjects have recovered in the treatment of 6 weeks, we can end treatment early.

Also known as: Abdominal Tuina Manipulation

Buspirone

Buspirone DRUG

Buspirone by mouth 5mg three times per day for 6week. If the subjects have recovered in the treatment of 6 weeks, we can end treatment early.

Also known as: Buspirone HCl

Abdominal Massage Therapy

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Meet criteria for a primary diagnosis of current GAD as demonstrated by a structured clinical interview for Diagnostic and Statistical Manual -IV（DSM-IV）；meet a diagnosis of Deficiency of both heart and spleen type.
• The scores of SAS≥50, 24≥the scores of HAMD ≥15.
• The symptoms of anxiety have continued not less than 6months.

You may not qualify if:

• major depression, schizophrenia ,bipolar disease other psychotic disorders, drug-dependent persons;
• patients with severe suicidal tendencies;
• women in pregnancy or breastfeeding, menstrual or postpartum recovery;
• suffered from serious illness or impairment of system,such as heart and brain blood vessels, lungs, liver, kidneys and blood system.
• persons allergic to Buspirone and excipient;
• persons suffering from epilepsy or hypertension or Glaucoma or myasthenia gravis or leukopenia;
• persons must be taking monoamine oxidase inhibitors;
• persons who drink a lot;
• persons with the local skin lesions in abdomen damage (such as damage, Burns, etc);
• persons with abdominal visceral tumors, nodules, inflammation, edema, abdominal aortic atherosclerosis;
• persons without the incompetence or unable to read, write and understand independently;
• persons whom the researchers believe should not participate in this study.

Sponsors & Collaborators

• Sun Qing: lead

Study Sites (1)

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300193, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Central Study Contacts

Jennifer Gao, Master

CONTACT

022-27432929; jennifergao1982@126.com

James Zhang, Master

CONTACT

022-27432929; james399@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: deputy director of the Tuina Department

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: July 10, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2015
• Last Updated: September 3, 2014

Record last verified: 2014-09

Locations

CN (1)