None listed
Conditions
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.
Interventions
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 men
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.
Sponsors
Osvaldo P Almeida
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
45 Years to 55 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed