Generalized Anxiety DisorderPhase 1/2CALMNCT00515242
Therapeutic Massage for Generalized Anxiety Disorder
A Phase 1/2 study testing massage, thermotherapy and relaxing environment in people with Generalized Anxiety Disorder, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this study is to compare the relative effectiveness of three relaxation treatments (therapeutic massage, thermotherapy, and time in a relaxing environment) in reducing anxiety in persons with Generalized Anxiety Disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- massage, thermotherapy and relaxing environment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2009
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Member of Group Health, Seattle metropolitan area
- Generalized Anxiety Disorder confirmed by SCID
- At least moderate anxiety
Who cannot join
- Serious mental health co-morbidity
- Any life threatening condition
- Currently receiving psychotherapy
- Substantial alcohol use
- Contraindications for massage
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98101
About this study
The purpose of this study is to compare the relative effectiveness of three relaxation treatments (therapeutic massage, thermotherapy, and time in a relaxing environment) in reducing anxiety in persons with Generalized Anxiety Disorder.
Read the detailed description
Anxiety and stress are costly problems that afflict millions of American adults. Together, they are among the most common reasons for which adults use complementary and alternative medical (CAM) therapies as well as more conventional relaxation therapies. Although massage is one of the most popular CAM treatments for anxiety, its effectiveness for this problem has never been rigorously evaluated. This study is designed to evaluate the effectiveness of massage as a treatment for a diagnosed anxiety disorder. Massage will be compared with two other relaxing treatments: thermotherapy and time in a relaxing environment, which reflect the types of activities that persons with anxiety might try to relieve their symptoms.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- massage, thermotherapy, relaxing environment
- Keywords
- massage therapy, relaxation treatments
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageBehavioural
therapeutic massage
thermotherapyBehavioural
heat therapy
relaxing environmentBehavioural
time in a relaxing environment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Therapeutic massage Receives: Behavioral: massage |
| 2 | Active comparator | Thermotherapy Receives: Behavioral: thermotherapy |
| 3 | Placebo comparator | Relaxation Receives: Behavioral: relaxing environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety
Measured: 6 months
Secondary outcomes (1)
worry, depression, disability
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Karen J. Sherman, PhD, MPH, Principal investigator, Group Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515242
- Sponsor's protocol ID
- R21AT002560
- Other IDs
- R21AT002560
- Acronym
- CALM
- Status last verified
- Oct 2017
- First submitted
- 9 Aug 2007
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Massage for Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00515242
- Acronym / sponsor ID
- CALM / R21AT002560
- Conditions
- Generalized Anxiety Disorder
- Keywords
- massage therapy, relaxation treatments
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Aug 2007 (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.
The purpose of this study is to compare the relative effectiveness of three relaxation treatments (therapeutic massage, thermotherapy, and time in a relaxing environment) in reducing anxiety in persons with Generalized Anxiety Disorder.
Detailed description
Anxiety and stress are costly problems that afflict millions of American adults. Together, they are among the most common reasons for which adults use complementary and alternative medical (CAM) therapies as well as more conventional relaxation therapies. Although massage is one of the most popular CAM treatments for anxiety, its effectiveness for this problem has never been rigorously evaluated. This study is designed to evaluate the effectiveness of massage as a treatment for a diagnosed anxiety disorder. Massage will be compared with two other relaxing treatments: thermotherapy and time in a relaxing environment, which reflect the types of activities that persons with anxiety might try to relieve their symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: massageTherapeutic massage |
| 2 | Active comparator | Behavioral: thermotherapyThermotherapy |
| 3 | Placebo comparator | Behavioral: relaxing environmentRelaxation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Member of Group Health, Seattle metropolitan area
- Generalized Anxiety Disorder confirmed by SCID
- At least moderate anxiety
Key exclusion criteria (5 listed)
- Serious mental health co-morbidity
- Any life threatening condition
- Currently receiving psychotherapy
- Substantial alcohol use
- Contraindications for massage
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 |
|---|---|---|
| massagetherapeutic massage | Behavioural | 1 |
| thermotherapyheat therapy | Behavioural | 2 |
| relaxing environmenttime in a relaxing environment | Behavioural | 3 |
Primary outcome
anxiety
Time frame: 6 months
1 secondary outcome
worry, depression, disability
Time frame: 6 months
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 13 Oct 2017.
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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.
Karen J. Sherman, PhD, MPH principal investigator
Group Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing massage, thermotherapy and relaxing environment in people with Generalized Anxiety Disorder, run by Kaiser Permanente 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 3 inclusion and 5 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 13 Oct 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
anxiety (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2017.