Beyond Ageing Project: A Study for the Prevention of Depression

Phase 2

Completed

• Conditions: Depression; Depressive Disorder
• Interventions: Drug: Folate (400mcg) and Vitamin B12 (100 mcg); Behavioral: mediated physical activity promotion; Behavioral: Mental health literacy; Drug: placebo; Behavioral: Nutrition information; Behavioral: pain and arthritis management information

• Registration Number: NCT00214682
• Lead Sponsor: Australian National University

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.

Study Timeline

• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Study Start: 2005-10
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-12
• Last Update Posted: 2011-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 909

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Folic acid (400mcg) + Vitamin B12 (100 mcg)	Folate (400mcg) and Vitamin B12 (100 mcg)	The vitamin intervention was a daily oral dose of one tablet consisting of folic acid 400 mcg + vitamin B12 100 mcg. The folic acid dose of 400 mcg / day was selected as it has been shown to be the dose associated with 90% of the maximal decrease in plasma homocysteine concentration for older individuals. Participants received 1 bottle x 200 tablets in six-month supplies at baseline, 6 months, 12 months, and 18 months. Adherence was monitored by telephone interviews (6 weeks, 6-, 12-, and 24 months) and 10 brief telephone tracking calls (1 - 5 weeks, and 4-, 8-, 13-, 18-, and 22-months).
Mediated physical activity promotion	mediated physical activity promotion	Individuals in the Physical Activity Promotion group received a manual designed to promote older individuals' physical activity participation to the level recommended to gain both physical and mental health benefits. The framework of the physical activity manual was informed by social cognitive theory and the transtheoretical model, and comprised five sections that reflect stages of behaviour change, including; precontemplation, contemplation, preparation, action, and maintenance. The manual contained evidence-based strategies and skills to assist people in increasing their physical activity levels. Participants received a pedometer at the commencement of the intervention as pedometry step / minute values are useful as an indicator of moderate to vigorous physical activity with total number of steps for one week recorded during the brief telephone calls at 1-5 weeks, and 4-, 8-, 13-, 18-, and 22- months.
Mental health literacy	Mental health literacy	This MHL intervention comprised 10 modules, with nine of these specifically written for older adults. Modules 1 to 5 comprised information on depression and the evidence-based treatment for older adults. The additional MHL modules were booklets addressing evidence-based strategies and treatments for depression. It was delivered in a way to foster support and ensure that participants worked through the material systematically. Modules 1 to 5 were delivered in consecutive weeks as previous research indicates that the maximum impact of MHL on depressive symptoms may occur within the first six weeks of the intervention. Telephone interviewers contacted participants once a week for 5 consecutive weeks to motivate and support participants. There were an additional 5 check-in telephone calls, and Modules 6 to 10 of the MHL material that were delivered via postal mail at 4- (Module 6), 8- (Module 7), 13- (Module 8), 18- (Module 9), and 22- months (Module 10).
Placebo tablet	placebo	A placebo tablet was the attention control intervention for the folic acid + vitamin B12 intervention group. Participants received 1 bottle x 200 tablets in 6-month supplies at baseline, 6 months, 12 months, and 18 months. Adherence was monitored by telephone interviews (6 weeks, 6-, 12-, and 24 months) and 10 brief telephone tracking calls (1 - 5 weeks, and 4-, 8-, 13-, 18-, and 22-months) during which participants counted their left-over tablets.
Nutrition information	Nutrition information	The attention control intervention for the physical activity intervention was printed nutrition literacy and included information concerning the recommended dietary guidelines for older Australians, as well as strategies and additional information to facilitate beneficial dietary behaviours. The same procedure was adhered to as the physical activity intervention to ensure adequate attention control. Participants in the nutrition promotion intervention received 5 brief telephone calls from an interviewer to facilitate adherence to the intervention, and to offer support and clarification of the materials. Participants received five further brief telephone calls as well as nutrition newsletters that were delivered via postal mail at 4-, 8-, 13-, 18-, and 22- months.
Pain and arthritis management information	pain and arthritis management information	Pain and Arthritis Information was used as the attention control intervention for the MHL intervention and comprised 10 modules. Modules 1 to 5 were contained in an Arthritis Australia consumer guide for arthritis management. Modules 6 to 10 were a series of information pamphlets on pain management, osteoporosis and falls prevention. The delivery of the Pain Information was identical to the MHL intervention with Modules 1 to 5 distributed via postal mail in five consecutive weeks (1-5 weeks), while the remaining intervention modules were delivered at 4- (Module 6), 8- (Module 7), 13- (Module 8), 18- (Module 9), and 22- months (Module 10). Participants also received 10 brief calls from a telephone interviewer that coincided with receiving the print intervention materials.

Primary Outcome Measures

Name	Time	Method
Depression	Baseline, 6 weeks, 6-, 12-, 48-, and 51 month followups.	The Patient Health Questionnaire - 9 (PHQ - 9) is a brief self-administered diagnostic instrument for depressive symptoms with items derived from the nine diagnostic criteria for Major Depression Disorder using the DSM - IV. The items are coded "0" (not at all) to "3" (nearly every day) for the most recent 2-week period, with possible scores ranging from 0 to 27, higher scores indicating greater depression severity. The PHQ - 9 is used in research and clinical settings, and can be administered via telephone. Studies support its reliability, validity, and ability to detect change over time.

Secondary Outcome Measures

Name	Time	Method
Physical activity level	Baseline, 6 weeks, 6-, 12-, 48-, and 51 month followups.	The International Physical Activity Questionnaire - Short Form (IPAQ - SF) was used as a self-report measure of physical activity. The purpose of the IPAQ is to survey physical activity in large groups or populations. The IPAQ allows for a total of metabolic equivalent (MET) units expended in the most recent seven-day period.
Cognitive impairment	Baseline, 12-, and 48-month followups.	The modified Telephone Interview of Cognitive Status has a max. total score= 39, and comprises 4 domains: orientation; recent memory and delayed recall; attention; and, semantic memory. It has excellent discrimination in cognitive performance in the general population. Processing speed was measured (Brief Test of Adult Cognition-Telephone) with the task to count backwards quickly from 100 by 1's for 30 seconds The Informant Questionnaire on Cognitive Decline in the Elderly was given at 2yr FU to a person who had known the participant for \> 2yrs. It measures cognitive decline and dementia.
Physical health outcomes	Baseline, 6-week, 6-, 12-, 24-, and 48-month followups.	A health checklist was given to determine current health status with items addressing the following health domains: cardiovascular, pulmonary, musculoskeletal, psychiatric, vision, and renal health; cancer, diabetes, and epilepsy. Blood collections were also used at baseline, 12- and 24 months to further investigate health including: thyroid stimulating hormone; liver and kidney function; fasting cholesterol and blood glucose; C-reactive protein; and haematological parameters.
B12 levels	Baseline, 12-, and 48-month followups.	Serum vitamin B12 was measured using chemiluminscent microparticle assays (Architect i2000, Abbott Laboratories). This allowed a check on whether participants were taking the supplements, and to initially to comply with inclusion/exclusion criteria.
Folate status	Baseline, 12-, and 48-month followups.	Red cell folate was measured using chemiluminscent microparticle assays (Architect i2000, Abbott Laboratories). This allowed a check on whether participants were taking the supplements, and as part of the initial screening process to comply with our inclusion/exclusion criteria.
Homocysteine	Baseline, 12- and 24-month followups.	A fluorescence polarization immunoassay was used for the quantitative determination of total L-homocysteine in plasma (AxSYM, Abbott Laboratories). This allowed us to establish any changes in Hcy concentration.

Trial Locations

Locations (1)

Australian National University; 🇦🇺 Canberra, Australian Capital Territory, Australia