SOMNA: Sleep Or Mood Novel Adjunctive therapy. The effectiveness of an adjunctive internet Cognitive Behavioural Therapy (CBT) intervention for insomnia in older men with depression.

Not Applicable

Completed

• Conditions: Depression; Anxiety; Insomnia; Mental Health - Depression; Mental Health - Anxiety; Mental Health - Other mental health disorders

• Registration Number: ACTRN12612000985886
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

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).

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in the severity of self reported depressive symptoms, as measured using the Centre for Epidemiological Studies Depression scale (CES-D) between baseline and week 12.[Timepoints where assessments will be made will be at baseline, weeks 4, 8 and 12.];The change in the severity of clinician rated depressive symtpoms as measured using the Hamilton Rating Depression Scale (HAM-D) between baseline and week 12.[Timepoints where assessment will be made will be at baseline and week 12.]

Secondary Outcome Measures

Name	Time	Method
The change in the severity of anxiety symptoms, as measured using the anxiety scale of the State Trait Personallity Inventory between baseline and week 12.[Timepoints where assessment will be made will be at baseline, week 12.];A change in the severity of insomnia symptoms, as measured using the Insomnia Severity Index rating scale between baseline and week 12.[Timepoints where assessment will be made will be at baseline, weeks 4, 8 and 12.]