ACTRN12622001026718招募中未知
Evaluating the effectiveness of a comprehensive lifestyle therapy program versus psychological care for managing mood disorders: The HARMON-E Trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 378
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Are 18 years or older
- •2.Have experienced a major depressive episode in the past two years
- •3.Score equal to or greater than 20 on the MADRS
- •4.Have capacity to provided informed consent and converse in English (or attend the program/assessments with a carer/companion who does)
- •5.Are suited to participation and engagement in a structured group-based lifestyle or psychotherapy program for 8 weeks
- •6.Have basic computer and internet literacy
排除标准
- •1.Endorse all the following lifestyle behaviours:
- •a.Non-smoker
- •Identified by answering ‘no’ to pre-screening question: Do you regularly smoke, chew or consume tobacco (current not past use)?
- •b.Report an optimal diet
- •Meeting the Australian Dietary Guidelines for fruit and vegetable intake
- •c.Sleep quality
- •High sleep quality Identified as having 7-9 hours of sleep most nights of the week
- •d.Physical activity
- •Identified by exceeding the national guidelines for physical activity in Australia
- •e.Alcohol & drug use
- •Identified by no recreational drug use and not exceeding alcohol recommendations in Australia
- •2.Severe food allergies, intolerances, aversions or malabsorption issues
- •3.Medically unfit to engage in an exercise program (may be determined by treating clinician)
- •4.Pregnant, breastfeeding, or planning pregnancy within the next year
- •5.Socio-cultural, religious, medical reasons precluding participation in a lifestyle intervention
- •6.Known or suspected clinically unstable systemic medical disorder
- •7.Participation in another study that involves an intervention
- •8.Current, or history of, a formal diagnosis and/or treatment for an eating disorder
- •Determined through online pre-screening questions:
- •a) Have you ever received a diagnosis or treatment for an eating disorder?”
- •If a participant answers ‘Yes’ to this question they will be excluded from the study.
- •b) In order to screen for undiagnosed eating disorders, all proceeding participants will complete the Sick, Control, One, Fat, Food (SCOFF) questionnaire. If an individual scores 3 or above, they will be excluded from the study.
- •9.Received treatment for an acute mental health concern in an inpatient setting or emergency department (e.g. suicidality, severe depressive state, mania, psychosis) within the last 30 days
- •10.Commencement of a new, duplicating treatment (e.g. medication, inpatient admission, psychotherapy) for a mental illness in the last 30 days
- •11.Experienced an episode of hypomania or mania in the last 30 days
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