The Young Adult Clinic (YAC) Study

Not Applicable

Recruiting

• Conditions: Chronic Pain; Insomnia; Insomnia Due to Medical Condition
• Interventions: Behavioral: DOZE app

• Registration Number: NCT05147974
• Lead Sponsor: Women's College Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-11-26
• Study First Submitted QC: 2021-11-26
• Study First Posted: 2021-12-07
• Study Start: 2023-04-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	DOZE app	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).

Primary Outcome Measures

Name	Time	Method
Study compliance to DOZE app intervention/Sleep diary	10 weeks	Number of Participants completing/using the DOZE app and completing the sleep diary daily during 10 weeks study intervention
Study recruitment/retention	12 weeks	Number of Participants recruited/dropping out of study (accrual/dropout rates)
Study DOZE app treatment evaluation	12 weeks	Participants' scoring on a 5 point Likert scale pre and post study intervention
Issues and concerns reported via phone calls and emails (Fidelity)	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Patient reported improvement in sleep	12 weeks	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%)
Patient reported improvement in Health Related Quality Of Life	12 weeks	Assessment of pain disability and intensity.PROMIS-29 A 29 item Questionnaire to assets physical, mental and social health and wellbeing.
Patient reported Global Impression of Change	12 weeks	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).
Patient reported improvement in pain	12 weeks	Number of Participants reporting Pain Inventory on a brief pain inventory scale of 0 to10.

Trial Locations

Locations (1)

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada