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临床试验/ACTRN12612000985886
ACTRN12612000985886已完成未知

A randomised controlled trial to evaluate whether a proven internet-delivered Cognitive Behavioural Therapy (CBT) treatment program for insomnia can improve the outcomes of standard treatment of depression in men.

The University of Sydney0 个研究点目标入组 80 人开始时间: 2012年9月13日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
80

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
50 Years 至 80 Years(—)
性别
Male

入选标准

  • All participants must meet the following inclusion criteria: (a) currently meet the criteria for at least minor depression (defined as screening positive (8+) on the Quick Inventory of Depression Symptomology (QIDS) and at clinical interview by having one of the two cardinal symptoms of Major Depressive Disorder (MDD) and at least two other symptoms of depression for two weeks or more (four symptoms minimum in total)); and (b) self report insomnia symptoms above the threshold (8+) Insomnia Severity Index (ISI).

排除标准

  • We will exclude participants if: (a) they have a history of psychosis, or hypo/manic episodes; (b) have a current substance dependence; (c) have a score of <24 on the Mini Mental State Examination; all as determined by the psychiatrist clinical interview; (d) are a rotating shift worker with overnight shifts or transmeridian travel >2 hours in the past month with inadequate time to readjust prior to trial commencement; (e) have all the criteria for Restless Legs Syndrome as defined using the RLS-12 at screening; (f) are at high risk for obstructive sleep apnea (OSA) as defined by the Berlin Questionnaire or have been treated for OSA.

研究者

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