Evaluating a digital app for sleep and pain management in young adults
Evaluating the Effectiveness of a Self-management Transdiagnostic Cognitive, Behavioral, Circadian Treatment on Patient Centered Outcomes Such as Self-efficacy, Pain Control and Overall Quality of Life in the Young Adult Chronic Pain Population
This study is testing a new app called DOZE to see if it can help young adults aged 18-25 with chronic pain and sleep problems feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 25 Years |
| Sex | All |
| Sponsor | Women's College Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05147974 on ClinicalTrials.gov |
What this trial studies
The Young Adult Clinic (YAC) study aims to assess the feasibility of the DOZE app, which provides a digital, transdiagnostic behavioral sleep medicine and self-management approach for young adults aged 18-25 suffering from chronic pain and sleep disorders. This study will explore the interactions between sleep, activity, and pain, and how they affect health-related quality of life. By implementing the DOZE app, researchers hope to gather data on its effectiveness in improving sleep health and pain management, while also determining the necessary sample size for future trials.
Who should consider this trial
Good fit: Ideal candidates for this study are young adults aged 18-25 with non-malignant chronic pain lasting more than 3 months and a clinically assessed sleep disorder.
Not a fit: Patients with severe psychiatric conditions, life-threatening medical issues, or those requiring urgent cognitive behavioral therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep and pain management strategies for young adults, enhancing their overall quality of life.
How similar studies have performed: While transdiagnostic behavioral sleep medicine is established in adults, its application in young adults with chronic pain is still in early development, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toronto, Ontario
- Women's College Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Mandeep Singh, M.D — Women's College Hospital
- Study coordinator: Laurentia Enesi, M.B, B.S
- Email: Laurentia.Enesi@wchospital.ca
- Phone: 416-323-6400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.