Clinical trial NCT00214682: Beyond Ageing Project: A Study for the Prevention of Depression
Official title: Beyond Ageing Project: A RCT to Assess the Benefit of Improving Mental Health Literacy as Well as the Effect of Folate and B12, and Physical Activity, in Preventing Major Depression and Cognitive Decline Among Older Australians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Depressive Disorder
Keywords: Depression
Cognition
Depressive disorder
Mental health literacy
Older adults
Randomzed controlled trial
Lead sponsor: Australian National University
Sponsor class: OTHER
Collaborators: name: Australian Government Department of Health and Ageing
name: University of Sydney
name: Commonwealth Scientific and Industrial Research Organisation, Australia
First posted: 2005-09-22
Enrollment: 909
Sex: ALL
Minimum age (years): 65
Maximum age (years): 74
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether folate and vitamin B12, physical activity and mental health literacy can prevent depression, and folate and vitamin B12 and physical activity can prevent cognitive impairment in older people. Also the study aims to assess the benefits for older people in improving their knowledge about mental health in relation to depression.

Detailed description: While preventive efforts for depression have tended to focus on adolescent and young adult populations, other stages of the lifespan also provide opportunities for prevention. With older people, there are certain risk and aetiological factors, which become more prominent and require preventive action at that point in the lifespan. The aim of this study is to determine the efficacy of various interventions in preventing depression and cognitive decline among older people who are at high risk of developing major depression because they are currently suffering from depressive symptoms.

The study has three interventions; i) folate and vitamin B12, ii) physical activity; and iii) mental health literacy. Participants will be randomly allocated to receive each combination of the interventions (folate and vitamin B12 or placebo, physical activity intervention programme or physical activity no-intervention control, mental health literacy intervention \[containing written modules with information about depression that is relevant to older people\] or mental health literacy no-intervention control group). Participants will receive these interventions over a two-year period with regular assessments across that time period.

Eligibility criteria: Inclusion Criteria:

* Aged 65-74 years with some depressive symptoms, assessed using the Kessler 10 Psychological Distress Scale \[K10\] (Andrews \& Slade, 2001)

Exclusion Criteria:

Any of the following:

* Those currently taking medication or receiving psychological treatment for depression
* A report of a medical diagnosis of bipolar disorder/mania
* History of epilepsy
* Diagnosed with cancer and/or on antifolate therapy
* Have a diagnosis of dementia or Alzheimer's disease
* Are currently taking vitamin supplements containing folate, B2, B6 or B12 at a dose exceeding 25% of the recommended daily intake.
* Medical contradictions to exercise (e.g., significant orthopaedic problems or cardiovascular disease that would prevent regular aerobic exercise)
* Ongoing participation in regular aerobic exercise.

Primary outcomes:
measure: Depression
timeFrame: Baseline, 6 weeks, 6-, 12-, 48-, and 51 month followups.
Secondary outcomes:
measure: Physical activity level
timeFrame: Baseline, 6 weeks, 6-, 12-, 48-, and 51 month followups.
measure: Cognitive impairment
timeFrame: Baseline, 12-, and 48-month followups.
measure: Physical health outcomes
timeFrame: Baseline, 6-week, 6-, 12-, 24-, and 48-month followups.
measure: B12 levels
timeFrame: Baseline, 12-, and 48-month followups.
measure: Folate status
timeFrame: Baseline, 12-, and 48-month followups.
measure: Homocysteine
timeFrame: Baseline, 12- and 24-month followups.
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Australian National University
state: Australian Capital Territory
Study officials:
affiliation: Centre for Mental Health Research, ANU
name: Professor Helen Christensen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ORYGEN Research Centre, University of Melbourne
name: Professor Anthony F Jorm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brain and Mind Research Institute, University of Sydney
name: Professor Ian Hickie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Mental Health Research, Australian National University, Canberra, Australia
name: Dr Janine G Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walker JG, Batterham PJ, Mackinnon AJ, Jorm AF, Hickie I, Fenech M, Kljakovic M, Crisp D, Christensen H. Oral folic acid and vitamin B-12 supplementation to prevent cognitive decline in community-dwelling older adults with depressive symptoms--the Beyond Ageing Project: a randomized controlled trial. Am J Clin Nutr. 2012 Jan;95(1):194-203. doi: 10.3945/ajcn.110.007799. Epub 2011 Dec 14.
citation: Christensen H, Aiken A, Batterham PJ, Walker J, Mackinnon AJ, Fenech M, Hickie IB. No clear potentiation of antidepressant medication effects by folic acid+vitamin B12 in a large community sample. J Affect Disord. 2011 Apr;130(1-2):37-45. doi: 10.1016/j.jad.2010.07.029.
citation: Walker JG, Mackinnon AJ, Batterham P, Jorm AF, Hickie I, McCarthy A, Fenech M, Christensen H. Mental health literacy, folic acid and vitamin B12, and physical activity for the prevention of depression in older adults: randomised controlled trial. Br J Psychiatry. 2010 Jul;197(1):45-54. doi: 10.1192/bjp.bp.109.075291.