NCT05137457

Brief Summary

The aim of the Young Adult Cognitive Behavioral Therapy (YAC) study is to evaluate the effectiveness of the Delivering Online "ZZZ's with Empirical support (DOZE) app, a unique digital cognitive behavioral therapy for insomnia (CBTi) in young adult patients with chronic pain.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 10, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

Same day

First QC Date

March 8, 2021

Last Update Submit

September 18, 2024

Conditions

InsomniaChronic PainInsomnia Due to Medical Condition

Keywords

InsomniaPain

Outcome Measures

Primary Outcomes (3)

  • Study recruitment/retention

    Number of Participants recruited/dropping out of study (accrual/dropout rates)

    1 year

  • Study compliance to DOZE app intervention/Sleep diary

    Number of Participants completing/using the DOZE app and completing the sleep diary during 10 weeks study intervention

    10 weeks

  • Study DOZE app treatment evaluation

    Participants' scoring on a 5 point Likert scale pre and post study intervention

    12 weeks

Secondary Outcomes (3)

  • Patient reported improvement in sleep & pain

    12 weeks

  • Patient reported improvement in Health Related Quality Of Life

    12 weeks

  • Patient reported Global Impression of Change

    12 weeks

Study Arms (2)

Delivering Online "ZZZ's with Empirical support (DOZE) app

EXPERIMENTAL

The mobile Cognitive Behavioral Therapy for insomnia (CBTi) will be offered using the Delivering Online "ZZZ's with Empirical support (DOZE) app. Patients assigned to the intervention group will be given the DOZE app which is an integrated smart phone app and web based self-management program for adolescents and young adults with sleep problems. The intervention will be delivered on restricted password-protected application. Participants will be encouraged to log onto the sleep dairy once a day over 10-weeks to complete sleep diary, develop and track their goals, and receive sleep health education tailored sleep health interventions. After 10-weeks, participants will complete questionnaires on sleep health, pain, and Health Related Quality of Life (HQRL). The use of actigraphy will be optional in view of the COVID19 pandemic.

Other: Delivering Online "ZZZ's with Empirical support (DOZE) appOther: Sleep diary

Sleep Diary Only Attention Control

ACTIVE COMPARATOR

The control group will receive the control version of the DOZE app where the patients will be able to access the sleep diary only, without the CBTi intervention. Participants will simply use the app to input entries into their sleep diary as an attention control over a 10-week period. After the 10-week intervention period, participants will again complete a battery of questionnaires on sleep health, pain, and HRQL. The use of actigraphy will be optional in view of the COVID19 pandemic.

Other: Sleep diary

Interventions

Delivering Online "ZZZ's with Empirical support (DOZE) appOTHER

The DOZE app is a unique digital CBTi intervention that can be used on any mobile phone, tablet or computer, using the iPhone Operating System (iOS) or Android software. It is an innovative program that consists of an integrated smart phone app and web self-management system ("DOZE") to help adolescents and young adults to sleep better. It allows data capture through entries in a sleep diary and calculation of specific clinical indices. The acquisition of baseline sleep health data over a two-week period is then used to provide personalized targets and tailored therapeutic interventions during the treatment phase. The app also includes a self-monitoring tool that fosters goal setting and provides feedback on sleep and goal attainment. DOZE allows for real time assessment of sleep related behaviors and customized reports and graphs from the young adults' data. The app provides reminders about specific goals and positive feedback (increasing scores) for each step towards a goal.

Delivering Online "ZZZ's with Empirical support (DOZE) app
Sleep diaryOTHER

The control group will receive the control version of the DOZE app where the patients will be able to access the sleep diary only, without the CBTi intervention. Participants will simply use the app to input entries into their sleep diary as an attention control over a 10-week period.

Delivering Online "ZZZ's with Empirical support (DOZE) appSleep Diary Only Attention Control

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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, Fourth Edition (DSM-IV) criteria for insomnia,
  • English speaking with
  • Access to a mobile phone or a computer with internet access.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersChronic PainPain

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Mandeep Singh, MD

    Women's College Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Following consent, participants will be randomized and allocated to either the intervention or control arm of the trial. Randomization will be centrally controlled, and allocation will be concealed using a secure, web-based randomization on the Research Electronic Data Capture (REDCap) platform. The patients, the clinical care team (pain physicians, sleep physician, occupational therapist, and social worker), outcome adjudicators and the study statisticians will all remain blinded to randomization and group allocation. The personnel teaching the app to the intervention group will be aware of group allocation
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective pilot study with participants randomized to either the intervention Delivering Online "ZZZ's with Empirical support- DOZE app with Sleep diary/Cognitive Behavioral Therapy for insomnia- CBTi) or attention control DOZE app with Sleep diary only groups. Participants will input entries into their sleep diary as an attention control over a 10-week period. For the intervention arm, mobile CBTi will be offered using the DOZE app, an integrated smart phone app and web based self-management program. The intervention will be delivered on restricted password-protected applications that will allow adherence to be tracked. Participants will log onto the sleep dairy once a day over 10-weeks to complete sleep diary entries, develop and track their goals, and receive sleep health education tailored sleep health interventions. After 10-weeks, participants will complete questionnaires on sleep health, pain, and Health Related Quality of Life. Actigraphy use will be optional
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

November 30, 2021

Study Start

August 10, 2021

Primary Completion

August 10, 2021

Study Completion

August 10, 2021

Last Updated

September 20, 2024

Record last verified: 2024-09

Locations

CA(1)