Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000756921
Ethics application status
Approved
Date submitted
18/07/2011
Date registered
20/07/2011
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Naturopathic Medicine for Improving Mood and Reducing Anxiety Study
Scientific title
Naturopathic Medicine for Improving Mood and Reducing Anxiety: A 16-Week, Naturalistic, Observational Study
Secondary ID [1] 262645 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 268359 0
Anxiety 268360 0
Condition category
Condition code
Alternative and Complementary Medicine 268488 268488 0 0
Herbal remedies
Mental Health 268489 268489 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An observational study of the outcome of Naturopathic Medicine over 16 weeks on depression and anxiety (i.e. normal individualised treatment by Naturopaths).

Common interventions used by Naturopaths may include: herbal medicines, nutrient supplements, dietary advice or modification, sleep or exercise advice, relaxation/meditation techniques, massage or manual therapy.
Intervention code [1] 266997 0
Not applicable
Comparator / control treatment
Naturalistic Observational Study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269232 0
Profile of Mood States form (POMS);
Timepoint [1] 269232 0
Week 0,1, 2,4,8, 12, 16
Primary outcome [2] 269233 0
Depression Anxiety Stress Scale (DASS)
Timepoint [2] 269233 0
Week 0,1, 2,4,8, 12, 16
Primary outcome [3] 269234 0
General Health Questionnaire Scale-28
Timepoint [3] 269234 0
Week 0,1, 2,4,8, 12, 16
Secondary outcome [1] 279175 0
Participants qualitative experience (via purpose-designed, semi-structured questions)
Timepoint [1] 279175 0
Week 1, 2,4,8, 12, 16

Eligibility
Key inclusion criteria
Any adults presenting with symptoms of depression and/or anxiety that has been ongoing for over two weeks.

The depression or anxiety can be identified by either the client or the practitioner
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Outside the age range
2) Competent in English reading, writing, and speaking

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
18/07/2011
Actual
18/07/2013
Date of last participant enrolment
Anticipated
Actual
18/11/2014
Date of last data collection
Anticipated
Actual
10/12/2014
Sample size
Target
200
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 267469 0
Self funded/Unfunded
Name [1] 267469 0
Country [1] 267469 0
Primary sponsor type
Individual
Name
Dr Jerome Sarris
Address
The Melbourne Clinic, 2 Salisbury Street, Richmond, Melbourne, Victoria, 3121
Country
Australia
Secondary sponsor category [1] 266514 0
None
Name [1] 266514 0
Address [1] 266514 0
Country [1] 266514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269438 0
The Mebourne Clinic
Ethics committee address [1] 269438 0
Ethics committee country [1] 269438 0
Australia
Date submitted for ethics approval [1] 269438 0
Approval date [1] 269438 0
08/07/2011
Ethics approval number [1] 269438 0
196

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

Contacts
Principal investigator
Name 32890 0
Prof Jerome Sarris
Address 32890 0
The Melbourne Clinic Professorial Unit
2 Salisbury St,
Richmond, VIC, 3121
Country 32890 0
Australia
Phone 32890 0
+613 9487 4748
Fax 32890 0
Email 32890 0
J.Sarris@westernsydney.edu.au
Contact person for public queries
Name 16137 0
Prof Jerome Sarris
Address 16137 0
The Melbourne Clinic,
2 Salisbury Street,
Richmond, Melbourne, Victoria 3121
Country 16137 0
Australia
Phone 16137 0
+613 9487 4748
Fax 16137 0
Email 16137 0
jsarris@unimelb.edu.au
Contact person for scientific queries
Name 7065 0
Prof Jerome Sarris
Address 7065 0
The Melbourne Clinic,
2 Salisbury Street,
Richmond, Melbourne, Victoria 3121
Country 7065 0
Australia
Phone 7065 0
+613 9487 4748
Fax 7065 0
Email 7065 0
jsarris@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants did not consent to this


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.