The Young Adult Clinic (YAC) Study

Study Overview
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Brief Summary
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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.

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

Official Title
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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

Conditions
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Insomnia, Chronic Pain, Insomnia Due to Medical Condition

Intervention / Treatment
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* Behavioral: DOZE app


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: This is a clinical trial as the DOZE app intervention is being assessed for improving outcomes in the YAC patient population. We propose a cohort of the YAC patients to be studied, pre & post-intervention, prospectively. All participants will be assigned to the intervention (complete DOZE app: Sleep diary and DOZE modules). Optional Actigraphy device use for measuring physical activity, sedentary behavior, sleep health parameters.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>A cohort of YAC patients to be studied, pre & post-intervention, prospectively. All participants will be assigned to the intervention (complete DOZE app: Sleep diary and DOZE modules). | Behavioral: DOZE app<br>* Complete DOZE app: Delivering Online ZZZ's with Empirical support (DOZE) app plus a Consensus Sleep Diary (CSD). The DOZE app, is a web-based app optimized for desktop, smartphone, or tablet use. It is a self-management program for adolescents and young adults with sleep problems. The intervention will be delivered on restricted password-protected applications that will allow tracking of adherence (number of logins to app and website using Google Analytics). Participants will be encouraged to log onto the sleep dairy (via automated alerts) once a day over a 10-week period to complete sleep diary entries, develop and track their goals, and receive sleep health education/tailored sleep health interventions. 1-week pre- and post- intervention, participants will complete a battery of baseline study questionnaires and have the option of using a Geneactiv actigraphy device along with a CSD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study recruitment/retention | Number of Participants recruited/dropping out of study (accrual/dropout rates) | 12 weeks | 
| Study compliance to DOZE app intervention/Sleep diary | Number of Participants completing/using the DOZE app and completing the sleep diary daily during 10 weeks study intervention | 10 weeks | 
| Study DOZE app treatment evaluation | Participants' scoring on a 5 point Likert scale pre and post study intervention | 12 weeks | 
| Issues and concerns reported via phone calls and emails (Fidelity) | Issues and concerns reported while using the intervention tracked by a research assistant, control strategy or outcome measures will be monitored. Can the intervention, and outcome measures be completed as planned or patient not comply with use. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported improvement in pain | Number of Participants reporting Pain Inventory on a brief pain inventory scale of 0 to10. | 12 weeks | 
| Patient reported improvement in Health Related Quality Of Life | Assessment of pain disability and intensity.PROMIS-29 A 29 item Questionnaire to assets physical, mental and social health and wellbeing. | 12 weeks | 
| Patient reported Global Impression of Change | Number of Participants reporting an improvement in PGIC in Questionnaire. It comprises 2 scales: PGIC has a 7-point scale depicting a patient's rating of overall improvement (from 1- worse/no change to 7- greatly better/considerable improvement; and a 10-point likert scale rating of efficacy of treatment (where 0- is much better and 10- is much worse). | 12 weeks | 
| Patient reported improvement in sleep | Adolescent sleep hygiene scale- 28 item self reported questionnaire Never (0%) Once in a while (20%) Sometimes (40%) Quite often (60%) Frequently, but not always (80%) Always (100%) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Pain