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Evaluating the Effectiveness of a Self-management Transdiagnostic Cognitive Treatment for Insomnia: The YAC Study. (YAC)

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ClinicalTrials.gov Identifier: NCT05147974
Recruitment Status : Not yet recruiting
First Posted : December 7, 2021
Last Update Posted : May 16, 2022
Sponsor:
Collaborator:
Ryerson University
Information provided by (Responsible Party):
Women's College Hospital

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.

Condition or disease Intervention/treatment Phase
Insomnia Chronic Pain Insomnia Due to Medical Condition Behavioral: DOZE app Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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).

Masking: None (Open Label)
Primary Purpose: Other
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 YAC Population
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : August 2023

Arm Intervention/treatment
Experimental: Intervention arm
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

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 Measures :
  1. Study recruitment/retention [ Time Frame: 12 weeks ]
    Number of Participants recruited/dropping out of study (accrual/dropout rates)

  2. Study compliance to DOZE app intervention/Sleep diary [ Time Frame: 10 weeks ]
    Number of Participants completing/using the DOZE app and completing the sleep diary daily during 10 weeks study intervention

  3. Study DOZE app treatment evaluation [ Time Frame: 12 weeks ]
    Participants' scoring on a 5 point Likert scale pre and post study intervention


Secondary Outcome Measures :
  1. Patient reported improvement in sleep & pain [ Time Frame: 12 weeks ]
    Number of Participants reporting Pain Inventory & Sleep Health improvement on a scale of 0 to 10

  2. Patient reported improvement in Health Related Quality Of Life [ Time Frame: 12 weeks ]
    Number of Participants reporting an improvement in HRQOL in Questionnaire Each item is scored from 0 (best score) to 5 (worst score). The total HRQL score is simply the sum of all the 10 items (best possible score: 0, worst possible score: 50)

  3. Patient reported Global Impression of Change [ Time Frame: 12 weeks ]
    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).



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05147974


Contacts
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Contact: Laurentia Enesi, M.B, B.S 416-323-6400 ext 2537 Laurentia.Enesi@wchospital.ca
Contact: Deborah Mancini 416-603-5800 ext 5269 deb.mancini@uhn.ca

Locations
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Canada, Ontario
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Contact: Laurentia Enesi, M.B, B.S    416-323-6400 ext 2537    Laurentia.Enesi@wchospital.ca   
Contact: Deborah Mancini    416-603-5800 ext 5269    deb.mancini@uhn.ca   
Principal Investigator: Mandeep Singh, MD         
Sponsors and Collaborators
Women's College Hospital
Ryerson University
Investigators
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Principal Investigator: Mandeep Singh, M.D Women's College Hospital
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Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT05147974    
Other Study ID Numbers: 2021-0075-B
First Posted: December 7, 2021    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Women's College Hospital:
Insomnia
Pain
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Chronic Pain
Pain
Neurologic Manifestations
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders