Lay summary
- Transdiagnostic sleep and circadian Intervention (TranS-C) is a treatment used to treat sleep difficulties, but little is known about the use of this intervention in Veterans and first responders.
- This trial aims to examine whether TranS-C, when delivered through telehealth, can help to reduce sleep issues and improve general functioning and well-being in Veterans. The group being tested are Veterans and first responders living with a diagnosable sleep condition(s) in Victoria, Australia.
- Participants will be randomly divided into two groups: one receiving the TranS-C intervention immediately and the other at a later point.
- Researchers will collect information from participants at three time points using a variety of tools. This includes data related to sleep quality, presence of sleep disorder, as well as symptoms of PTSD, depression and anxiety. Participants will also be asked about their satisfaction with the TranS-C intervention and telehealth delivery to better understand how feasible the intervention is for this group.
- The data will be used to determine the effectiveness of TranS-C. The results of the study will be useful for understanding treatment options for sleep difficulties in Veterans and first responders. The TIRED trial is registered with the Australian Clinical Trial Registry (ACTRN12621000433808).
Scientific summary
The TIRED trial is a pilot randomized controlled trial aimed to investigate the effectiveness of a telehealth-delivered novel treatment for sleep disorders called transdiagnostic sleep and circadian intervention (TranS-C). The trial will examine whether TranS-C treatment delivered via telehealth by a qualified mental health clinician can effectively reduce sleep disorder symptoms and improve functioning and well-being. The trial will recruit Veterans and first responders with a diagnosable sleep disorder(s) who live in Victoria, Australia. Eligible participants are randomly allocated into one of the two conditions: (1) an immediate Trans-C treatment group, or (2) a delayed TranS-C treatment/wait-list group. The immediate treatment group will receive between four and ten weekly TranS-C treatment sessions, which run for 50 minutes each. Participants will be assessed at pre-treatment, post-treatment, and three-month follow-up. The primary outcome is sleep quality assessed using the Pittsburgh Sleep Quality Index. Presence of a sleep disorder is also assessed using structured clinical interview for DSM V-Sleep Disorders (SCID-SD). As part of the TranS-C treatment, participants are asked to complete measures of subjective sleep quality using a sleep diary delivered via a purpose-designed smartphone app. Wristwatch-based actigraphy is also employed to collect objective sleep quality measurements via movement detection using an inbuilt accelerometer. A number of secondary outcomes will also be assessed including severity of PTSD symptoms (PCL-5), depression symptoms (PHQ), and anxiety symptoms (GAD). Finally, the feasibility of delivering the TranS-C intervention via telehealth will be assessed using the Client Satisfaction Questionnaire (CSQ-8), and satisfaction with telehealth will be assessed using the Teleneuropsychology Patient Experience Survey (TPES). The TIRED trial has been registered with Australian Clinical Trial Registry under the following registration number ACTRN12621000433808.
Lay summary
- Transdiagnostic sleep and circadian Intervention (TranS-C) is a treatment used to treat sleep difficulties, but little is known about the use of this intervention in Veterans and first responders.
- This trial aims to examine whether TranS-C, when delivered through telehealth, can help to reduce sleep issues and improve general functioning and well-being in Veterans. The group being tested are Veterans and first responders living with a diagnosable sleep condition(s) in Victoria, Australia.
- Participants will be randomly divided into two groups: one receiving the TranS-C intervention immediately and the other at a later point.
- Researchers will collect information from participants at three time points using a variety of tools. This includes data related to sleep quality, presence of sleep disorder, as well as symptoms of PTSD, depression and anxiety. Participants will also be asked about their satisfaction with the TranS-C intervention and telehealth delivery to better understand how feasible the intervention is for this group.
- The data will be used to determine the effectiveness of TranS-C. The results of the study will be useful for understanding treatment options for sleep difficulties in Veterans and first responders. The TIRED trial is registered with the Australian Clinical Trial Registry (ACTRN12621000433808).
Scientific summary
The TIRED trial is a pilot randomized controlled trial aimed to investigate the effectiveness of a telehealth-delivered novel treatment for sleep disorders called transdiagnostic sleep and circadian intervention (TranS-C). The trial will examine whether TranS-C treatment delivered via telehealth by a qualified mental health clinician can effectively reduce sleep disorder symptoms and improve functioning and well-being. The trial will recruit Veterans and first responders with a diagnosable sleep disorder(s) who live in Victoria, Australia. Eligible participants are randomly allocated into one of the two conditions: (1) an immediate Trans-C treatment group, or (2) a delayed TranS-C treatment/wait-list group. The immediate treatment group will receive between four and ten weekly TranS-C treatment sessions, which run for 50 minutes each. Participants will be assessed at pre-treatment, post-treatment, and three-month follow-up. The primary outcome is sleep quality assessed using the Pittsburgh Sleep Quality Index. Presence of a sleep disorder is also assessed using structured clinical interview for DSM V-Sleep Disorders (SCID-SD). As part of the TranS-C treatment, participants are asked to complete measures of subjective sleep quality using a sleep diary delivered via a purpose-designed smartphone app. Wristwatch-based actigraphy is also employed to collect objective sleep quality measurements via movement detection using an inbuilt accelerometer. A number of secondary outcomes will also be assessed including severity of PTSD symptoms (PCL-5), depression symptoms (PHQ), and anxiety symptoms (GAD). Finally, the feasibility of delivering the TranS-C intervention via telehealth will be assessed using the Client Satisfaction Questionnaire (CSQ-8), and satisfaction with telehealth will be assessed using the Teleneuropsychology Patient Experience Survey (TPES). The TIRED trial has been registered with Australian Clinical Trial Registry under the following registration number ACTRN12621000433808.