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Trial registered on ANZCTR


Registration number
ACTRN12611000675921
Ethics application status
Approved
Date submitted
23/06/2011
Date registered
5/07/2011
Date last updated
16/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Piloting osteopathic manipulative treatment for depression in peri-menopausal women
Scientific title
In peri-menopausal women with depression, is osteopathic manipulative treatment combined with counselling better than counselling alone in reducing symptoms of depression?
Secondary ID [1] 262457 0
Nil
Universal Trial Number (UTN)
U1111-1122-1800
Trial acronym
OSTEO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 268146 0
Menopause 268230 0
Condition category
Condition code
Mental Health 268282 268282 0 0
Depression
Physical Medicine / Rehabilitation 268283 268283 0 0
Other physical medicine / rehabilitation
Reproductive Health and Childbirth 268361 268361 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1.
Counselling, using cognitive behavioural therapy. Cognitive behavioural therapy (CBT) is a widely used and effective form of managing depression. CBT is based on an underlying theory that the way a person sees or experiences the world determines the way she behaves and feels. Therapy sessions are designed to identify these assumptions, provide a reality-test and correct assumptions that are distorted or dysfunctional. The person learns to master situations that previously were believed to be unchangeable and or insurmountable. She learns to change her thought processes to ones that are more functional and support her in her day to day life. All counselling sessions will be conducted one-on-one. The will be facilitated by Master of Psychology or Doctor of Psychology students under the supervision of experienced psychologists. A weekly consultation will be held for eight weeks, with a follow-up consultation occurring three months later. Each session will take up to 60 minutes.

Arm 2.
CBT plus osteopathic manipulative therapy. Osteopathy is a form of manual medicine which recognises the important link between the structure of the body and the way it functions. It utilizes a wide range of hands-on techniques to improve the function of the body. The OMT consultations will be conducted by a registered osteopath with a minimum of five years experience. Each participant will receive four OMT consultations within an eight week period that coincides with the eight weeks of CBT. The initial consultation will take 60 minutes, with the remaining three taking 30-45 minutes.
Intervention code [1] 266819 0
Treatment: Other
Intervention code [2] 266820 0
Behaviour
Comparator / control treatment
Control - Counselling, using cognitive behavioural therapy. Cognitive behavioural therapy (CBT) is a widely used and effective form of managing depressio. CBT is based on an underlying theory that the way a person sees or experiences the world determines the way she behaves and feels. Therapy sessions are designed to identify these assumptions, provide a reality-test and correct assumptions that are distorted or dysfunctional. The person learns to master situations that previously were believed to be unchangeable and or insurmountable. She learns to change her thought processes to ones that are more functional and support her in her day to day life. Eight consultations will be held weekly and a follow-up consultation will occur three months later. Each session will take up to 60 minutes.
Control group
Active

Outcomes
Primary outcome [1] 269016 0
DASS42 depression scores
Timepoint [1] 269016 0
At baseline, and at 1, 5, 8 and 20 weeks after intervention commencement
Secondary outcome [1] 276822 0
Secondary Outcome 1: menopausal symptoms using the Greene Climacteric Scale
Timepoint [1] 276822 0
Timepoints 1: at baseline, and at 1, 5, 8 and 20 weeks after intervention commencement
Secondary outcome [2] 276823 0
Secondary Outcome 2: therapeutic alliance using the Working Alliance Inventory
Timepoint [2] 276823 0
Timepoints 2: at week 1, 5 and 8 after intervention commencement.

Eligibility
Key inclusion criteria
Signs and symptoms consistent with peri-menopause and depressed mood or mild-moderate depression as determined by the Greene Climacteric Scale and the DASS, but otherwise healthy individuals
Minimum age
45 Years
Maximum age
60 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Coexisting infectious disease, medical or surgical conditions, including, but not limited to, suspected or known malignancy, regular migraines or headaches, non-evaluated trauma, unresolved back pain, history of drug abuse, history of seizures, pregnancy, history of mental illness prior to menopausal symptoms occurring, use of muscle relaxants or pain medication eight hours before examination. Military service in the Middle East.

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 concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4137 0
3072
Recruitment postcode(s) [2] 4138 0
3073
Recruitment postcode(s) [3] 4139 0
3074
Recruitment postcode(s) [4] 4140 0
3075
Recruitment postcode(s) [5] 4141 0
3076
Recruitment postcode(s) [6] 4142 0
3078
Recruitment postcode(s) [7] 4143 0
3079
Recruitment postcode(s) [8] 4144 0
3081
Recruitment postcode(s) [9] 4145 0
3082
Recruitment postcode(s) [10] 4146 0
3083
Recruitment postcode(s) [11] 4147 0
3084
Recruitment postcode(s) [12] 4148 0
3085
Recruitment postcode(s) [13] 4149 0
3087
Recruitment postcode(s) [14] 4150 0
3088
Recruitment postcode(s) [15] 4151 0
3089
Recruitment postcode(s) [16] 4152 0
3091
Recruitment postcode(s) [17] 4153 0
3093
Recruitment postcode(s) [18] 4154 0
3094
Recruitment postcode(s) [19] 4155 0
3095
Recruitment postcode(s) [20] 4156 0
3099
Recruitment postcode(s) [21] 4157 0
3105
Recruitment postcode(s) [22] 4158 0
3106
Recruitment postcode(s) [23] 4159 0
3113
Recruitment postcode(s) [24] 4160 0
3752

Funding & Sponsors
Funding source category [1] 267293 0
University
Name [1] 267293 0
RMIT University
Address [1] 267293 0
PO Box 71, Bundoora, Victoria, 3083.
Country [1] 267293 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
PO Box 71, Bundoora, Victoria, 3083
Country
Australia
Secondary sponsor category [1] 266360 0
None
Name [1] 266360 0
Address [1] 266360 0
Country [1] 266360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269288 0
RMIT University Human Research Ethics Committee
Ethics committee address [1] 269288 0
Research and Innervation,
RMIT University,
GPO Box 2476 V,
Melbourne, Victoria, 3001
Ethics committee country [1] 269288 0
Australia
Date submitted for ethics approval [1] 269288 0
Approval date [1] 269288 0
02/03/2011
Ethics approval number [1] 269288 0
6110

Summary
Brief summary
The aim of this research is to determine if osteopathic manipulative treatment (OMT) along with cognitive behavioural therapy (CBT) provides a better management of depressive symptoms in peri-menopausal women when compared to CBT alone. Peri-menopause is the three years, or more, prior to menopause, which is the final menstrual period a women experiences. It is hypothesised peri-menopausal women who receive OMT as part of their managment of mild depression or depressed mood will demonstrate a greater improvement in their depressive symptoms than those peri-menopausal women who receive only counselling.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32780 0
Dr Paula Henderson
Address 32780 0
RMIT University, PO Box 71, Bundoora, Victoria, 3083
Country 32780 0
Australia
Phone 32780 0
+61 3 9925 7221
Fax 32780 0
Email 32780 0
paula.henderson@rmit.edu.au
Contact person for public queries
Name 16027 0
Dr Paula Henderson
Address 16027 0
RMIT University,
PO Box 71,
Bundoora,
Victoria, 3083
Country 16027 0
Australia
Phone 16027 0
+61 3 9925 7221
Fax 16027 0
+61 3 9925 7795
Email 16027 0
paula.henderson@rmit.edu.au
Contact person for scientific queries
Name 6955 0
Dr Paula Henderson
Address 6955 0
RMIT University,
PO Box 71,
Bundoora,
Victoria, 3083.
Country 6955 0
Australia
Phone 6955 0
+61 3 9925 7221
Fax 6955 0
+61 3 9925 7795
Email 6955 0
paula.henderson@rmit.edu.au

No information has been provided regarding IPD availability
Summary results
No Results