The Young Adult Clinic (YAC) Study (YAC)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Insomnia; Insomnia Due to Medical Condition
• Intervention / Treatment: Behavioral: DOZE app

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study DOZE app treatment evaluation	Participants' scoring on a 5 point Likert scale pre and post study intervention	12 weeks
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
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 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 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 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

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Collaborators: Toronto Metropolitan University
• Investigators: Principal Investigator: Mandeep Singh, M.D, Women's College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): March 2, 2026

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Insomnia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Chronic Pain; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2021-0075-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No