Clinical trial NCT05147974: The Young Adult Clinic (YAC) Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Chronic Pain
Insomnia Due to Medical Condition
Keywords: Insomnia
Pain
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Toronto Metropolitan University
First posted: 2021-12-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Study recruitment/retention
timeFrame: 12 weeks
measure: Study compliance to DOZE app intervention/Sleep diary
timeFrame: 10 weeks
measure: Study DOZE app treatment evaluation
timeFrame: 12 weeks
measure: Issues and concerns reported via phone calls and emails (Fidelity)
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient reported improvement in pain
timeFrame: 12 weeks
measure: Patient reported improvement in Health Related Quality Of Life
timeFrame: 12 weeks
measure: Patient reported Global Impression of Change
timeFrame: 12 weeks
measure: Patient reported improvement in sleep
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Mandeep Singh, M.D
role: PRINCIPAL_INVESTIGATOR
References: