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The Young Adult Clinic (YAC) Study (YAC)

Primary Purpose

Insomnia, Chronic Pain, Insomnia Due to Medical Condition

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
DOZE app
Sponsored by
Women's College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Insomnia focused on measuring Insomnia, Pain

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Young adult patients aged 18 - 25 years old, who have
  • Non-malignant chronic pain lasting more than 3 months, with
  • Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for insomnia
  • 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.

Sites / Locations

  • Women's College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm 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).

Outcomes

Primary Outcome Measures

Study recruitment/retention
Number of Participants recruited/dropping out of study (accrual/dropout rates)
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
Study DOZE app treatment evaluation
Participants' scoring on a 5 point Likert scale pre and post study intervention
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.

Secondary Outcome Measures

Patient reported improvement in pain
Number of Participants reporting Pain Inventory on a brief pain inventory scale of 0 to10.
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.
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).
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%)

Full Information

First Posted
November 26, 2021
Last Updated
June 8, 2023
Sponsor
Women's College Hospital
Collaborators
Toronto Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT05147974
Brief Title
The Young Adult Clinic (YAC) Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's College Hospital
Collaborators
Toronto Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: To examine the variance in effectiveness outcomes, including sleep health, pain, and overall Health Related Quality of Life (HRQL). To determine the required sample size for a future definitive trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Chronic Pain, Insomnia Due to Medical Condition
Keywords
Insomnia, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
DOZE app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Study recruitment/retention
Description
Number of Participants recruited/dropping out of study (accrual/dropout rates)
Time Frame
12 weeks
Title
Study compliance to DOZE app intervention/Sleep diary
Description
Number of Participants completing/using the DOZE app and completing the sleep diary daily during 10 weeks study intervention
Time Frame
10 weeks
Title
Study DOZE app treatment evaluation
Description
Participants' scoring on a 5 point Likert scale pre and post study intervention
Time Frame
12 weeks
Title
Issues and concerns reported via phone calls and emails (Fidelity)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Patient reported improvement in pain
Description
Number of Participants reporting Pain Inventory on a brief pain inventory scale of 0 to10.
Time Frame
12 weeks
Title
Patient reported improvement in Health Related Quality Of Life
Description
Assessment of pain disability and intensity.PROMIS-29 A 29 item Questionnaire to assets physical, mental and social health and wellbeing.
Time Frame
12 weeks
Title
Patient reported Global Impression of Change
Description
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).
Time Frame
12 weeks
Title
Patient reported improvement in sleep
Description
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%)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurentia Enesi, M.B, B.S
Phone
416-323-6400
Ext
2537
Email
Laurentia.Enesi@wchospital.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Ortiz
Phone
416-323-6400
Ext
5105
Email
rachel.ortiz@wchospital.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandeep Singh, M.D
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurentia Enesi, M.B, B.S
Phone
416-323-6400
Ext
2537
Email
Laurentia.Enesi@wchospital.ca
First Name & Middle Initial & Last Name & Degree
Didem Bozak
Phone
416-323-6008
Email
didem.bozak@wchospital.ca
First Name & Middle Initial & Last Name & Degree
Mandeep Singh, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Young Adult Clinic (YAC) Study

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