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Effectiveness of Cognitive Behavioral Therapy for Insomnia in Young Adults With Chronic Pain (YAC)

Primary Purpose

Insomnia, Chronic Pain, Insomnia Due to Medical Condition

Status

Withdrawn

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

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

Sleep diary

About this trial

This is an interventional other 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, Fourth Edition (DSM-IV) 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 Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Sleep Diary Only Attention Control

Arm Description

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.

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.

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 during 10 weeks study intervention

Study DOZE app treatment evaluation

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

Secondary Outcome Measures

Patient reported improvement in sleep & pain

Number of Participants reporting Pain Inventory & Sleep Health improvement on a scale of 0 to 10

Patient reported improvement in Health Related Quality Of Life

Number of Participants reporting an improvement in HRQOL in Questionnaire

Patient reported Global Impression of Change

Number of Participants reporting an improvement in PGIC in Questionnaire

Full Information

NCT ID

NCT05137457

First Posted

March 8, 2021

Last Updated

November 26, 2021

Sponsor

Women's College Hospital

Collaborators

Toronto Metropolitan University

1. Study Identification

Unique Protocol Identification Number

NCT05137457

Brief Title

Effectiveness of Cognitive Behavioral Therapy for Insomnia in Young Adults With Chronic Pain

Acronym

YAC

Official Title

Evaluating the Effectiveness of Cognitive Behavioral Therapy for Insomnia on Patient Centered Outcomes Such as Self Efficacy, Pain Control and Overall Quality of Life in the Young Adult Chronic Pain Population: The Young Adult CBTi (YAC)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Withdrawn

Why Stopped

An RCT was not valid anymore as app has become open source and will risk a contamination of study population

Study Start Date

November 2021 (Anticipated)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

December 2022 (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

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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). Cognitive behavioral therapy for insomnia (CBTi) is a behavioral modification approach and is currently a frontline therapy for adults with sleep disorders. However, CBTi is still in early stages of development for adolescent and young adult populations, and less so for youth with comorbid 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.

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

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

Sleep Diary Only Attention Control

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Sleep diary

Intervention Description

Primary Outcome Measure Information:

Title

Study recruitment/retention

Description

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

Time Frame

1 year

Title

Study compliance to DOZE app intervention/Sleep diary

Description

Number of Participants completing/using the DOZE app and completing the sleep diary 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

Secondary Outcome Measure Information:

Title

Patient reported improvement in sleep & pain

Description

Number of Participants reporting Pain Inventory & Sleep Health improvement on a scale of 0 to 10

Time Frame

12 weeks

Title

Patient reported improvement in Health Related Quality Of Life

Description

Number of Participants reporting an improvement in HRQOL in Questionnaire

Time Frame

12 weeks

Title

Patient reported Global Impression of Change

Description

Number of Participants reporting an improvement in PGIC in Questionnaire

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

Eligibility 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, Fourth Edition (DSM-IV) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mandeep Singh, MD

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

12. IPD Sharing Statement

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Effectiveness of Cognitive Behavioral Therapy for Insomnia in Young Adults With Chronic Pain

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