The Young Adult Clinic (YAC) Study

NCT05147974 | Completed

• 1 other identifier: 2021-0075-B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Chronic Pain; Insomnia Due to Medical Condition

Keywords

Insomnia; Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Patient reported improvement in pain

  12 weeks

• Patient reported improvement in Health Related Quality Of Life

  12 weeks

• Patient reported Global Impression of Change

  12 weeks

• Patient reported improvement in sleep

  12 weeks

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Interventions

DOZE app BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's College Hospital: lead
• Toronto Metropolitan University: collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mandeep Singh, M.D

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 7, 2021
• Study Start: April 20, 2023
• Primary Completion: August 1, 2025
• Study Completion: March 2, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)