Piloting osteopathic manipulative treatment for depression in peri-menopausal women

In peri-menopausal women with depression, is osteopathic manipulative treatment combined with counselling better than counselling alone in reducing symptoms of depression?

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000675921

Acronym

OSTEO

Enrollment

Registered

2011-07-05

Start date

2011-07-04

Completion date

2011-09-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

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 60 Years

Healthy volunteers

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

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.

Outcome results