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The Young Adult Clinic (YAC) Study

The Young Adult Clinic (YAC) Study

Recruiting
18-25 years
All
Phase N/A

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Overview

The overarching aim of the Young Adult Clinic (YAC) study is to evaluate the DOZE app, a digital, transdiagnostic behavioral sleep medicine and self-management approach in young adult patients (ages 18-25) with chronic pain.

Description

Sleep, activity, and pain interactions have the potential to impact almost all important protective and regulatory processes in the body. Long-term sleep disruption is associated with increased pain sensitivity, prolonged pain duration, and development of chronic pain. Degree of pain relief can directly impact the quality and disruption of sleep, mood, behavior, social participation, and has a devastating impact on Health Related Quality of Life (HRQL).

Transdiagnostic behavioral sleep medicine and self-management is a behavioral modification approach and is currently a frontline therapy like Cognitive behavioral therapy for insomnia (CBTi) in adults with sleep disorders. However, it is still in early stages of development for adolescent and young adult populations, and less so for youth with co-morbid mental and physical health conditions and chronic pain.

Primary aim: Assess the feasibility of implementing the DOZE app.

Secondary aim:

  1. To examine the variance in effectiveness outcomes, including sleep health, pain, and overall Health Related Quality of Life (HRQL).
  2. To determine the required sample size for a future definitive trial.

Eligibility

Inclusion Criteria:

  • Young adult patients aged 18 - 25 years old, who have
  • Non-malignant chronic pain lasting more than 3 months, with
  • Clinically assessed as having a sleep disorder
  • English speaking with
  • Access to a mobile phone or a computer with internet access.

Exclusion Criteria:

  • Patients who require urgent CBT treatment as per their health care provider
  • Patients who have received CBT in the past 3 months
  • Patients participating in other psychological treatments and/or drug trials during the study
  • Patients who have other significant medical conditions- Life threatening (e.g. cancer), neurological conditions (e.g. epilepsy)
  • Patients who have other significant psychiatric conditions-Severe depression or active suicide intent
  • Situations resulting in forced sleep disruption or derangement of sleep schedule such as night shift work > 2 nights per week in the past 3months
  • Pregnancy or breastfeeding.
  • Inability to communicate with health care providers or the research personnel
  • Inability to fill out self-report questionnaires, study materials, or follow instructions.

Study details
    Insomnia
    Chronic Pain
    Insomnia Due to Medical Condition

NCT05147974

Women's College Hospital

30 April 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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