Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000429459
Ethics application status
Approved
Date submitted
7/08/2007
Date registered
23/08/2007
Date last updated
23/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A new medical approach on depression and anxiety stress-related: the Neuro Psycho Physical Optimization with Conveyer of Modulating Radiance (CRM) therapy.
Scientific title
Neuro Psycho Physical Optimization (ONPF) with Conveyer of Modulating Radiance (CMR) therapy. Is it effective in reducing the subjective perception of stress, stress correlated anxiety and depression?
Universal Trial Number (UTN)
Trial acronym
CRMTO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress correlated anxiety and depression 2222 0
Condition category
Condition code
Mental Health 2313 2313 0 0
Depression
Mental Health 2314 2314 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
688 subjects were selected randomly from a 888 group to be subjected to a cycle of Neuro Psycho Physical Optimization (ONPF) with CMR therapy and 200 subjects were used for the control group.The instrument used in this study is a biomedical radiofrequency instrument, called Conveyer of Modulating Radiance (CRM) authorized by the Italian Ministry of Health, in accordance with Directive 93/42/EEC.The empiric protocol used, called Neuro Psycho Physical Optimization (ONPF)®, involves the application of a probe of the CMR® on specific points of the auricular pavilion for an activation time of roughly 500 mms. The ONPF ® protocol is activated in a precise sequence on seven auricular points.The protocol envisages 18 sessions of ONPF® treatment on alternating days, for eight (8)weeks.
In this study we have chosen the PSM Test to investigate if an NPPO® cycle with CMR® therapy - is effective in reducing the subjective perception of stress, stress correlated anxiety and depression.
Intervention code [1] 1933 0
Treatment: Devices
Intervention code [2] 1999 0
Treatment: Devices
Comparator / control treatment
The reduction of the symptomatology of stress correlated anxiety and depression after an NPPO® cycle with CMR® therapy shows significant results (P<.05) with respect to a control group that was treated with inactivated CRM.
Control group
Placebo

Outcomes
Primary outcome [1] 3210 0
The PSM Test. This test has good convergent validity with the Brief Symptom Inventory (r = .76), the Beck Depression Inventory (r = .75), and with Spielberger's anxiety scale (State subscale r = .73) (Dion, 1988; Lemyre et al., 1991
Timepoint [1] 3210 0
At time zero and after the cycle of therapy, around two months
Secondary outcome [1] 5349 0
Wellbeing - Neuro Psycho Physical Optimization
Timepoint [1] 5349 0
At time zero and after the cycle of therapy, around two months

Eligibility
Key inclusion criteria
Patients suffering from depression and anxiety stress related
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects taking psychotropic medication or suffering from psychiatric pathologies were excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not conceled
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by an external operator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
888
Accrual to date
Final
Recruitment outside Australia
Country [1] 558 0
Italy
State/province [1] 558 0

Funding & Sponsors
Funding source category [1] 2539 0
Charities/Societies/Foundations
Name [1] 2539 0
Istitituto Rinaldi Fontani
Country [1] 2539 0
Italy
Primary sponsor type
Charities/Societies/Foundations
Name
Istituto Rinaldi Fontani
Address
Via Nazionale 23, 50123 Firenze - Italy
www.irf.it
Country
Italy
Secondary sponsor category [1] 2253 0
Charities/Societies/Foundations
Name [1] 2253 0
Societa Di Ottimizzazione Neuro Psico Fisica E CRM Terapia
Address [1] 2253 0
Via Nazionale 23, 50123 Firenze
www.sonc.it
Country [1] 2253 0
Italy
Secondary sponsor category [2] 2297 0
University
Name [2] 2297 0
University of Firenze - Department of Public Medicine ? Occupational Health
Address [2] 2297 0
Largo Palagi, 1 - 50139 Firenze
Tel. 055 417769 Fax 055 4278130
E-mail cupellivao-careggi.toscana.it
Country [2] 2297 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4383 0
Societa Di Ottimizzazione Neuro Psico Fidica E CRM Terapia
Ethics committee address [1] 4383 0
Ethics committee country [1] 4383 0
Italy
Date submitted for ethics approval [1] 4383 0
Approval date [1] 4383 0
Ethics approval number [1] 4383 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27747 0
Address 27747 0
Country 27747 0
Phone 27747 0
Fax 27747 0
Email 27747 0
Contact person for public queries
Name 11122 0
Fontani Vania M.D.
Address 11122 0
Via Nazionale 23
50123 Firenze
Country 11122 0
Italy
Phone 11122 0
+39 055 290307
Fax 11122 0
Email 11122 0
[email protected]
Contact person for scientific queries
Name 2050 0
Salvatore Rinaldi M.D.
Address 2050 0
Via Nazionale 23
50123 Firenze
Country 2050 0
Italy
Phone 2050 0
+39 055 290307
Fax 2050 0
Email 2050 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.