InsomniaYACNCT05137457
Effectiveness of Cognitive Behavioral Therapy for Insomnia in Young Adults With Chronic Pain
A study testing Delivering Online "ZZZ's with Empirical support (DOZE) app and Sleep diary in people with Insomnia and Chronic Pain, run by Women's College Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Insomnia, Chronic Pain, Insomnia Due to Medical Condition
- What is being tested?
- Delivering Online "ZZZ's with Empirical support (DOZE) app and Sleep diary
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 10 Aug 2021to 10 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Insomnia, Chronic Pain, Insomnia Due to Medical Condition
- Being tested
- Delivering Online "ZZZ's with Empirical support (DOZE) app, Sleep diary
- Keywords
- Insomnia, Pain
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivering Online "ZZZ's with Empirical support (DOZE) appOther
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 diaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Delivering Online "ZZZ's with Empirical support (DOZE) app | Experimental | 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. Receives: Other: Delivering Online "ZZZ's with Empirical support (DOZE) app; Other: Sleep diary |
| Sleep Diary Only Attention Control | Active comparator | 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. Receives: Other: Sleep diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study recruitment/retention
Number of Participants recruited/dropping out of study (accrual/dropout rates)
Measured: 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
Measured: 10 weeks
Study DOZE app treatment evaluation
Participants' scoring on a 5 point Likert scale pre and post study intervention
Measured: 12 weeks
Secondary outcomes (3)
Patient reported improvement in sleep & pain
Number of Participants reporting Pain Inventory \& Sleep Health improvement on a scale of 0 to 10
Measured: 12 weeks
Patient reported improvement in Health Related Quality Of Life
Number of Participants reporting an improvement in HRQOL in Questionnaire
Measured: 12 weeks
Patient reported Global Impression of Change
Number of Participants reporting an improvement in PGIC in Questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start10 Aug 2021
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Why it stopped: An RCT was not valid anymore as app has become open source and will risk a contamination of study population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Mandeep Singh, MD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137457
- Sponsor's protocol ID
- 2020-0103-B
- Acronym
- YAC
- Status last verified
- Sep 2024
- First submitted
- 8 Mar 2021
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05137457
- Acronym / sponsor ID
- YAC / 2020-0103-B
- Conditions
- Insomnia, Chronic Pain, Insomnia Due to Medical Condition
- Keywords
- Insomnia, Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: An RCT was not valid anymore as app has become open source and will risk a contamination of study population
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Toronto Metropolitan University
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Delivering Online "ZZZ's with Empirical support (DOZE) app | Experimental | Other: Delivering Online "ZZZ's with Empirical support (DOZE) app, Other: Sleep diaryThe 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. |
| Sleep Diary Only Attention Control | Active comparator | Other: Sleep diaryThe 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delivering Online "ZZZ's with Empirical support (DOZE) appThe 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 | Delivering Online "ZZZ's with Empirical support (DOZE) app |
| Sleep diaryThe 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. | Other | Delivering Online "ZZZ's with Empirical support (DOZE) app, Sleep Diary Only Attention Control |
Primary outcome
Study recruitment/retention
Time frame: 1 year
Number of Participants recruited/dropping out of study (accrual/dropout rates)
Study compliance to DOZE app intervention/Sleep diary
Time frame: 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
Time frame: 12 weeks
Participants' scoring on a 5 point Likert scale pre and post study intervention
3 secondary outcomes
Patient reported improvement in sleep & pain
Time frame: 12 weeks
Patient reported improvement in Health Related Quality Of Life
Time frame: 12 weeks
Patient reported Global Impression of Change
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mandeep Singh, MD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivering Online "ZZZ's with Empirical support (DOZE) app and Sleep diary in people with Insomnia and Chronic Pain, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study recruitment/retention (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.