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临床试验/ACTRN12621000387820
ACTRN12621000387820进行中(未招募)未知

Evaluating the effectiveness of telehealth lifestyle therapy versus telehealth psychotherapy for reducing depression in adults with COVID-19 related distress: The CALM trial

Deakin University0 个研究点目标入组 182 人开始时间: 2021年4月8日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
入组人数
182

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 a Distress Questionnaire-5 (DQ5) score >8 at enrolment
  • 3. Are deemed suitable by a treating clinician for participation in a structured lifestyle or psychotherapy program for 8 weeks
  • 4. Are willing to commit to six 90-minute sessions over an eight-week period
  • 5. Are willing to provide blood and stool samples on two occasions
  • 6. Have basic computer and internet literacy
  • 7. Have capacity to provide informed consent and converse in English

排除标准

  • 1. Aged <18 years
  • 2. No/low distress (DQ5 score <8); or in crisis or suicidal at time of enrolment (as determined by treating clinician and/or case manager)
  • 3. Known or suspected clinically unstable systemic medical disorder
  • 4. Severe food allergies, intolerances, aversions or malabsorption issues
  • 5. Medically unfit to engage in an exercise program (may be determined by treating clinician)
  • 6. Pregnant, breastfeeding, or planning pregnancy within the next year
  • 7. Socio-cultural, religious, medical reasons precluding participation in a lifestyle intervention
  • 8. Commencement of a new, duplicating treatment (e.g. psychotherapy) for a mental illness within a one-month period prior to baseline OR continuing symptoms which are treatment resistant on medication.
  • 9. Participation in another study that involves an intervention
  • 10. Current or history of an eating disorder

研究者

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