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

Chronic Pain Clinical Trial

— 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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05137457
• Other study ID #: 2020-0103-B
• Status: Withdrawn
• Phase: N/A
• Start date: November 2021
• Est. completion date: December 2022

Study information

• Verified date: November 2021
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Insomnia
• Insomnia Due to Medical Condition
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Women's College Hospital	Ryerson University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study recruitment/retention	Number of Participants recruited/dropping out of study (accrual/dropout rates)	1 year
Primary	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
Primary	Study DOZE app treatment evaluation	Participants' scoring on a 5 point Likert scale pre and post study intervention	12 weeks
Secondary	Patient reported improvement in sleep & pain	Number of Participants reporting Pain Inventory & Sleep Health improvement on a scale of 0 to 10	12 weeks
Secondary	Patient reported improvement in Health Related Quality Of Life	Number of Participants reporting an improvement in HRQOL in Questionnaire	12 weeks
Secondary	Patient reported Global Impression of Change	Number of Participants reporting an improvement in PGIC in Questionnaire	12 weeks