Clinical trial NCT05137457: Effectiveness of Cognitive Behavioral Therapy for Insomnia in Young Adults With Chronic Pain
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Insomnia
Chronic Pain
Insomnia Due to Medical Condition
Keywords: Insomnia
Pain
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Toronto Metropolitan University
First posted: 2021-11-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Study recruitment/retention
timeFrame: 1 year
measure: Study compliance to DOZE app intervention/Sleep diary
timeFrame: 10 weeks
measure: Study DOZE app treatment evaluation
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient reported improvement in sleep & pain
timeFrame: 12 weeks
measure: Patient reported improvement in Health Related Quality Of Life
timeFrame: 12 weeks
measure: Patient reported Global Impression of Change
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Mandeep Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: