The TIRED trial - Transdiagnostic Intervention for Remote Ex-military and first-responDers study

Not Applicable

Recruiting

• Conditions: Sleep Disorders; Posttraumatic Stress Disorder; Mental Health - Other mental health disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12621000433808
• Lead Sponsor: Phoenix Australia - Centre for Posttraumatic Mental Health, Department of Psychiatry, University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-16
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1) Aged 18 years or older.
2) Are a Victorian-based veteran or first responder
3) Have access to an electronic device offering audio-visual connectivity to Zoom.
4) Meet criteria for diagnosable sleep disorder.
5) Are able to maintain a stable dose throughout the assessment and treatment period if on a pre-existing medication.

Exclusion Criteria

•Current serving members of the ADF.
•Participants residing outside of state of Victoria (excluding residents of towns on the Victorian border)
•Participants who meet criteria for a current diagnosis of severe Alcohol or other Substance Use disorder.
•Participants who are actively psychotic or manic, or acutely suicidal or pose another form of risk to self or other warranting alternative, immediate intervention.
•Participants who are enrolled in another service offering sleep treatment.
•Participants who report persistent, poorly controlled pain interfering with sleep.
•Participants who report serious medical condition, interfering with sleep.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of sleep symptoms--assessed using the Pittsburgh Sleep Quality Index (PSQI). [posttreatment - 2 weeks after treatment completion ];Satisfaction with the TranS-C treatment--assessed using the Client Satisfaction Questionnaire[posttreatment - 2 weeks after treatment completion ];Satisfaction of telehealth treatment delivery--assessed using the Teleneuropsychology Patient Experience Survey[Posttreatment - 2 weeks after treatment completion ]

Secondary Outcome Measures

Name	Time	Method
Posttraumatic Stress Disorder severity-assessed using the PTSD Checklist for DSM-5 (PCL-5) [posttreatment, follow-up (3-months posttreatment)];Symptoms of depression--assessed using the Patient Health Questionnaire-9 (PHQ9)[posttreatment, follow-up (3-months posttreatment)];Symptoms of Anxiety--assessed using the Generalized Anxiety Disorder 7-item scale (GAD7)[posttreatment, follow-up (3-months posttreatment)];Posttraumatic Stress Disorder diagnosis- assessed with PTSD module of the Mini International Neuropsychiatric Interview (MINI) [posttreatment, follow-up (3-months posttreatment)];Sleep disorder diagnosis - assessed using The Structured Clinical Interview for DSM-5 Sleep Disorders - Revised[posttreatment, follow-up (3-months posttreatment)];Alcohol use severity - assessed with Alcohol Use Disorders Identification Test (AUDIT)[posttreatment, follow-up (3-months posttreatment)]