Insomnia, Chronic Pain, Insomnia Due to Medical Condition
Conditions
Keywords
Insomnia, Pain
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.
Interventions
OTHERDelivering 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.
OTHERSleep 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.
Sponsors
Toronto Metropolitan University
Women's College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study recruitment/retention | 1 year | Number of Participants recruited/dropping out of study (accrual/dropout rates) |
| Study compliance to DOZE app intervention/Sleep diary | 10 weeks | Number of Participants completing/using the DOZE app and completing the sleep diary during 10 weeks study intervention |
| Study DOZE app treatment evaluation | 12 weeks | Participants' scoring on a 5 point Likert scale pre and post study intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported improvement in sleep & pain | 12 weeks | 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 | 12 weeks | Number of Participants reporting an improvement in HRQOL in Questionnaire |
| Patient reported Global Impression of Change | 12 weeks | Number of Participants reporting an improvement in PGIC in Questionnaire |
Countries
Canada
Outcome results
None listed