RecruitingACTRN12621000433808

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

A pilot randomised controlled trial of telehealth delivered Transdiagnostic Intervention for Sleep Disorders and Circadian Rhythms (TRANS-C) among ex-military personnel and first responders

Sponsor

Phoenix Australia - Centre for Posttraumatic Mental Health, Department of Psychiatry, University of Melbourne

Enrollment

58 participants

Start Date

Oct 1, 2020

Study Type

Interventional

Conditions

Sleep Disorders Posttraumatic Stress Disorder

Summary

By the nature of their work, veterans and first-responders are vulnerable to developing difficulties with sleep (e.g. insomnia), and these problems can sometimes affect mental health and vice versa. The aim of this clinical trial is to investigate the effectiveness of a new treatment for sleep disorders called the Transdiagnostic Sleep and Circadian Intervention (Trans-C), and its efficacy when delivered using tele-health (via videoconferencing). In this trial, the Trans-C treatment is provided to veterans and first responders who meet the trial eligibility criteria. Eligible participants will be randomly allocated into one of two conditions: 1) an immediate treatment condition or 2) a wait-list delayed treatment condition (individuals who receive treatment after 12 weeks waiting period). Participation also involves completing a number of clinical interviews and self-report questionnaires over the duration of the trial. Additional daily assessments of sleep quality is also collected using a smartphone app, and objective sleep quality data is collected via a provided actigraph (i.e., watch) worn for the duration of treatment. Early studies using TranS-C intervention are showing that sleep can be improved, as well as benefits gained in mental health and overall well being, and this trial is examining whether similar benefits can be seen when treatment is delivered via telehealth, and if improvements can also be seen in high risk exposed populations such as veterans and first responders. We expect that participants who receive the TranS-C intervention, will demonstrate significant improvements in sleep, as well as other mental health symptoms (e.g., PTSD, depression, anxiety). In addition to this, we expect that participants will be satisfied with the TranS-C treatment, as well as the delivery of the treatment via tele-health.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Veterans and first responders — including police, paramedics, and firefighters — face unique stressors through their work that make sleep disorders very common in this group. Poor sleep and mental health problems like PTSD and depression often reinforce each other. This trial tests a new treatment called the Transdiagnostic Sleep and Circadian Intervention (TranS-C), delivered by telehealth via Zoom, that addresses a range of sleep disorders at once. You may be eligible if you are a Victorian-based veteran or first responder (not currently serving in the ADF), aged 18 or older, have a diagnosable sleep disorder, access to a device for video calls, and are not currently enrolled in another sleep treatment programme. People with severe substance use disorders, active psychosis, or persistent uncontrolled pain are not eligible. Participants are randomly assigned to either immediate treatment or a 12-week waitlist before treatment begins. The programme involves regular sessions with a clinician over videoconference, plus daily tracking of sleep using a smartphone app and a wristwatch-style device. The study hopes to show that effective, evidence-based sleep treatment can be delivered remotely to people who may live far from specialist services.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The primary intervention in this trial is the Transdiagnostic Intervention for Sleep Disorders and Circadian Rhythms (TranS-C). Trans-C is a module driven approach incorporating aspects of all evidence based psychological approaches to the treatment of sleep problems. Trans-C is a module driven approach incorporating aspects of all evidence based psychological approaches to the treatment of sleep problems. The TranS-C intervention consists of four cross-cutting models, four core modules and seven optional modules delivered over 4-10 sessions depending on the complexity of the presentation (Harvey & Buysse, 2018). Participants will be with individual participants, who will receive between 4 – 10 weekly 50-minute sessions. This intervention will be delivered by registered psychologists and the mode of delivery will be via telehealth (specifically, videoconferencing). The intervention is a manualised modular treatment and treatment sessions vary depending on presentation of sleep disorder symptoms. The location of treatment will be in the participants' own homes using video and audio enabled devices. The therapy will be delivered by psychologists within the Phoenix Australia Traumatic Stress Clinic. Treatment will be delivered according to the Transdiagnostic Sleep and Circadian Intervention clinician manual (Harvey et al. 2018). Sessions will be audio recorded for the purposes of fidelity testing. ten percent of audio recordings will be accessed by senior members of trial team for purpose of fidelity testing. A key component of treatment involves the completion of daily sleep diary entries to track/monitor sleep habits. Using an ecological-momentary-assessment framework, a digitised version of the TranS-C sleep diary is utilised in this trial to enable participants to complete daily diary entries on their personal smartphone devices.