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 sites80 target enrollmentSeptember 13, 2012

Overview

No summary available.

Registry

who.int

Start Date

September 13, 2012

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Male

Sponsor

•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).

•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.