Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000724774
Ethics application status
Approved
Date submitted
28/06/2013
Date registered
1/07/2013
Date last updated
24/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Healthy Menopausal Transition Study: Randomised trial to reduce depression during the menopausal transition
Scientific title
Randomised single blind trial investigating whether a health coaching intervention compared to standard care reduces the 12 month incidence of depression in women undergoing the menopausal transition with or without subsyndromal symptoms of depression.
Secondary ID [1] 282751 0
Nil
Universal Trial Number (UTN)
U1111-1145-1270
Trial acronym
HealthyTrans
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive symptoms and depressive disorders 289484 0
Menopausal transition 289485 0
Condition category
Condition code
Mental Health 289812 289812 0 0
Depression
Reproductive Health and Childbirth 289832 289832 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health Coaching Intervention and Standard Medical Care.
A health coaching program will be delivered across a 6 month period and will consist of 8 sessions delivered over the telephone of 30 - 45 minute duration (baseline, week 2, week 4, week 8, week 12, week 26, week 32, week 36). Written educational material will be posted to all participants in the intervention group.

The health coaching program is designed to:
1. offer verbal and written access to evidence- based information about the menopausal transition and its management

2. offer quality information and building of skills and capacity to manage bothersome issues identified

3. promote changes to hazardous lifestyle practices associated with increased risk of depression and poor health outcomes

4. offer education about mental health, with a particular focus on depression

5. optimise the management of chronic medical conditions

6. promote monitoring and active surveillance of depressive symptoms.
Intervention code [1] 287417 0
Lifestyle
Intervention code [2] 287418 0
Behaviour
Comparator / control treatment
Standard medical care will be provided by the treating general practitioner of participants in both the intervention and control groups.
Control group
Active

Outcomes
Primary outcome [1] 289886 0
The diagnosis of major depression or dysthymia according to DSM IV. The diagnosis will be based upon the use of a structured diagnostic neuropsychiatric interview (The MINI interview).
Timepoint [1] 289886 0
Data on endpoints will be collected 8, 26 and 52 weeks after the baseline assessment.
Secondary outcome [1] 303481 0
1. Change in the severity of depressive and anxiety symptoms, as measured by the Patient Health Questionnaire (PHQ-9) and the Hospital Anxiety Depression Scale (HADS).
Timepoint [1] 303481 0
Baseline and at eight, twenty-six and fifty-two weeks after baseline.
Secondary outcome [2] 303509 0
2. Change in lifestyle practices: physical activity, smoking, alcohol use, body mass index.
- Physical activity: self-reported frequency and number of minutes per week of vigorous physical activity (which makes participant huff and puff).
- Alcohol use: AUDIT score
- Smoking: self-reported history of smoking and, for current smokers, number of cigarettes smoked per day.
- Body mass index (BMI): self-reported height and weight will be used to calculate BMI in Kg/m2,
Timepoint [2] 303509 0
Data on endpoints will be collected 8, 26 and 52 weeks after the baseline assessment.
Secondary outcome [3] 303510 0
3. Change in quality of life, as measured by the 12-item Short-Form Health Survey (SF-12).
Timepoint [3] 303510 0
Data on endpoints will be collected 8, 26 and 52 weeks after the baseline assessment.

Eligibility
Key inclusion criteria
We will include women who are:
1. aged 45 - 55years
2. experiencing no or subthreshold depressive symptoms (PHQ-9<15)
3. experiencing recent (last 5 years) onset of irregular menstrual cycles (7 days or more difference in length of consecutive cycles) or 2 or more skipped cycles and at least one interval of amenorrhea of 60 days or more)
4. amenorrhea for 12 months or more
5. Alcohol Audit score less than or equal to 15
Minimum age
45 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from participating if:
1. they disclose a history of gynecological surgery that compromises the ability to assign menopausal status (i.e. hysterectomy, bilateral oophorectomy, endometrial ablation)

2. they report illness that may impact upon 12-month survival (e.g. metastatic cancer)

3. they receive medical treatment or undergo medical procedures that impacts the ability to assign menopausal stage (hormone therapy, hormonal Intra Uterine Devices, contraceptive implants, patches or medications)

4. there is evidence of clinically significant depressive symptoms (PHQ 9 score =15 or more).

5. there is evidence of concurrent alcohol abuse or dependency (AUDIT score greater than15).

6. they report a history of schizophrenia, delusional disorder, schizoaffective disorder or bipolar disorder

7. there is evidence of significant hearing or visual impairment

8. they are not fluent in written or spoken English

9. they plan to leave Western Australia in the next 12 months

10. they do not have an active general practitioner or do not consent to the research team liaising with their general practitioner throughout the course of the study

11. they fail to provide written informed consent

12. they report active suicidal intent

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)
Eligible participants will be randomly assigned to the Health Coaching or Standard Care group. Allocation will be concealed from both eligible participants and the assessor who determined eligibility. The allocation will involve contacting the holder of the allocation schedule at the WA Centre for Health & Ageing - this person is not involved in any aspect of the collection of data for this trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation table will consist of a list of random numbers generated by computer.
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
Sample size: We expect that 14% of participants in the control group will develop a depressive episode over 12 months compared with 6% of people in the health coaching group (absolute risk reduction of 8%, 95%CI 0.8%,15.2%). The expected number of people needed to treat to prevent one person developing depression is 12.5. The expected prevalence was derived from population based studies showing that the prevalence of clinically significant symptoms of depression during the menopausal transition is about 14% compared with about 6% during other times. A sample size of 300 women (1:1 allocation) will give the study 80% power to declare such a difference as statistically significant (alpha 5%). These numbers take into account loss of 40 women during follow up.

We will use means and standard deviations to describe continuous variables with normal distribution, medians and inter-quartile ranges for ranked variables and frequency tables for categorical variables. We will evaluate the primary endpoint of the study (cumulative incidence of depression) according to the intervention using logit models. Potential confounders will be taken into account by means of statistical modelling. Changes of scores over time will be investigated using mixed models that will take into account the severity of symptoms at the baseline assessment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/04/2013
Actual
12/04/2013
Date of last participant enrolment
Anticipated
15/12/2014
Actual
6/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
351
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 7044 0
6000 - Perth
Recruitment postcode(s) [2] 7045 0
6009 - Broadway Nedlands
Recruitment postcode(s) [3] 7046 0
6014 - Floreat
Recruitment postcode(s) [4] 7047 0
6010 - Claremont
Recruitment postcode(s) [5] 7048 0
6009 - Dalkeith
Recruitment postcode(s) [6] 7049 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 287521 0
Charities/Societies/Foundations
Name [1] 287521 0
The Ron and Peggy Bell Family Legacy
Country [1] 287521 0
Australia
Primary sponsor type
Individual
Name
Osvaldo P Almeida
Address
WA Centre for Health & Ageing
University of Western Australia
35 Stirling Highway
Crawley, WA 6009
Country
Australia
Secondary sponsor category [1] 286285 0
Individual
Name [1] 286285 0
Leon Flicker
Address [1] 286285 0
WA Centre for Health & Ageing
University of Western Australia
35 Stirling Highway
Crawley, WA 6009
Country [1] 286285 0
Australia
Other collaborator category [1] 277504 0
Individual
Name [1] 277504 0
Andrew Ford
Address [1] 277504 0
WA Centre for Health & Ageing
University of Western Australia
35 Stirling Highway
Crawley, WA 6009
Country [1] 277504 0
Australia
Other collaborator category [2] 277505 0
Individual
Name [2] 277505 0
Kylie Marsch
Address [2] 277505 0
WA Centre for Health & Ageing
University of Western Australia
35 Stirling Highway
Crawley, WA 6009
Country [2] 277505 0
Australia
Other collaborator category [3] 277506 0
Individual
Name [3] 277506 0
Jon Pfaff
Address [3] 277506 0
WA Centre for Health & Ageing
University of Western Australia
35 Stirling Highway
Crawley, WA 6009
Country [3] 277506 0
Australia
Other collaborator category [4] 277507 0
Individual
Name [4] 277507 0
Moira Sim
Address [4] 277507 0
WA Centre for Health & Ageing
University of Western Australia
35 Stirling Highway
Crawley, WA 6009
Country [4] 277507 0
Australia
Other collaborator category [5] 277508 0
Individual
Name [5] 277508 0
Martha Hickie
Address [5] 277508 0
The Royal Women's Hospital
Locked Bag 300
Grattan St & Flemington Rd
Parkville, VIC 3052
Country [5] 277508 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289498 0
UWA Human Research Ethics Committee
Ethics committee address [1] 289498 0
Research, Ethics and Biosafety office
Research Services
The University of Western Australia
35 Stirling Highway, Crawley, Perth, W.A. 6009
Ethics committee country [1] 289498 0
Australia
Date submitted for ethics approval [1] 289498 0
Approval date [1] 289498 0
12/12/2012
Ethics approval number [1] 289498 0
RA/4/1/5790
Ethics committee name [2] 289499 0
Human Research Ethics Committe (DOH WA)
Ethics committee address [2] 289499 0
DOHWA HREC
1st Floor C Block
189 Royal St
East Perth WA 6004
Ethics committee country [2] 289499 0
Australia
Date submitted for ethics approval [2] 289499 0
Approval date [2] 289499 0
01/01/2013
Ethics approval number [2] 289499 0
2013/09

Summary
Brief summary
Menopause is the point in time when a woman’s menstrual periods stop. The years leading up to a woman’s final period is referred to as the “menopausal transition” and, on average, lasts 4 to 7 years. Previous research has found that about 1 in every 4 women experience symptoms of depression during this transition period. Some women may also notice changes that include: irregular menstrual periods, hot flushes, sleep disruption, night sweats, vaginal and urinary problems and low libido. Fortunately, the most bothersome features of the menopausal transition can be managed successfully, including the changes in mood. What we would now like to find out is if we can prevent changes in mood occurring altogether by addressing relevant risk factors for depression that might be present during the menopausal transition. This project requires the participation of midlife women who are experiencing symptoms consistent with the lead up to menopause. Eligible participants will be randomly assigned into one of two groups:

Standard Medical Care or Standard Medical Care and a Health Coaching Program

Women allocated to the health coaching program will have access to a health coach for a minimum of 8 telephone coaching sessions. The health coach will offer informational material on menopausal transition, depression and healthy lifestyle behaviours in addition to providing problem solving skills based training. A series of validated self-report measures will be mailed to all study participants at four time points (Baseline and at 8 weeks, 26 weeks and 52 weeks). These measures will collect demographic, lifestyle and clinical information. The primary outcome of this study is the diagnosis of depression (major depressive episode or dysthymia) according to DSM IV at follow up. We will test the following hypothesis: women randomly assigned to health coaching program will have a lower 12 month prevalence of depression than women randomly assigned to standard care.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41090 0
Prof Osvaldo Almeida
Address 41090 0
W.A. Centre for Health and Ageing
Level 6, Ainslie House
48 Murray Street
Perth WA 6000
Country 41090 0
Australia
Phone 41090 0
+61 8 9224 2855
Fax 41090 0
Email 41090 0
[email protected]
Contact person for public queries
Name 41091 0
Dr Kylie Marsh
Address 41091 0
W.A. Centre for Health and Ageing
Level 6, Ainslie House
48 Murray Street
Perth WA 6000
Country 41091 0
Australia
Phone 41091 0
+61 8 9224 3095
Fax 41091 0
Email 41091 0
[email protected]
Contact person for scientific queries
Name 41092 0
Prof Osvaldo Almeida
Address 41092 0
W.A. Centre for Health and Ageing
Level 6, Ainslie House
48 Murray Street
Perth WA 6000
Country 41092 0
Australia
Phone 41092 0
61 8 9224 2855
Fax 41092 0
Email 41092 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
SourceTitleYear of PublicationDOI
EmbaseReducing depression during the menopausal transition with health coaching: Results from the healthy menopausal transition randomised controlled trial.2016https://dx.doi.org/10.1016/j.maturitas.2016.07.012
N.B. These documents automatically identified may not have been verified by the study sponsor.