The Young Adult Clinic (YAC) Study

Women's College Hospital

Status: Enrolling

Conditions: Insomnia Due to Medical Condition; Chronic Pain; Insomnia

Treatments: Behavioral: DOZE app

Study type: Interventional

Funder types: Other

Identifiers

NCT05147974

2021-0075-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intervention arm

Experimental group

Description:

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).

Treatment:

Behavioral: DOZE app