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

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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Pain; Insomnia; Insomnia Due to Medical Condition
• Intervention / Treatment: Other: Delivering Online "ZZZ's with Empirical support (DOZE) app; Other: Sleep diary

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delivering Online "ZZZ's with Empirical support (DOZE) app; 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) app; 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.; Other: Sleep diary; 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.
Active Comparator: Sleep Diary Only Attention Control; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported improvement in sleep & pain	Number of Participants reporting Pain Inventory & Sleep Health improvement on a scale of 0 to 10	12 weeks
Patient reported improvement in Health Related Quality Of Life	Number of Participants reporting an improvement in HRQOL in Questionnaire	12 weeks
Patient reported Global Impression of Change	Number of Participants reporting an improvement in PGIC in Questionnaire	12 weeks

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Collaborators: Toronto Metropolitan University
• Investigators: Principal Investigator: Mandeep Singh, MD, Women's College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): August 10, 2021
• Study Completion (Actual): August 10, 2021

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Chronic Pain; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2020-0103-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No