The Young Adult Clinic (YAC) Study

Chronic Pain Clinical Trial

— YAC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05147974
• Other study ID #: 2021-0075-B
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Women's College Hospital
• Contact: Laurentia Enesi, M.B, B.S
• Phone: 416-323-6400
• Email: Laurentia.Enesi[@]wchospital.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Insomnia
• Insomnia Due to Medical Condition
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Women's College Hospital	Toronto Metropolitan University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study recruitment/retention	Number of Participants recruited/dropping out of study (accrual/dropout rates)	12 weeks
Primary	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
Primary	Study DOZE app treatment evaluation	Participants' scoring on a 5 point Likert scale pre and post study intervention	12 weeks
Primary	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	Patient reported improvement in pain	Number of Participants reporting Pain Inventory on a brief pain inventory scale of 0 to10.	12 weeks
Secondary	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
Secondary	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
Secondary	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