InsomniaNCT04512768
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
A study testing Transdiagnostic Internet-delivered Cognitive Behaviour Therapy and Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia in people with Insomnia and Anxiety, run by University of Regina at 1 site in Canada.
Trial summary
Transdiagnostic Internet-delivered Cognitive Behaviour Therapy (ICBT) is an efficacious treatment option for anxiety and depression; however, not all patients benefit equally and some leave treatment before program completion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Anxiety, Depression
- What is being tested?
- Transdiagnostic Internet-delivered Cognitive Behaviour Therapy and Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteCanada
- Study dates
- 9 Sep 2020to 30 Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must reside in Saskatchewan
- Participants must have access to a computer and feel comfortable using the internet
- Participants must be willing to provide a medical contact (e.g., family doctor) in case of medical emergency
- Participants must endorse some symptoms of anxiety or depression
- Participants must also endorse significant symptoms of insomnia (Insomnia Severity Index score of 10 or above)
Who cannot join
- High risk of suicide
- Unmanaged severe psychiatric illness (e.g., psychosis, mania)
- Severe alcohol or addictions problems that require referral
- High probability that another sleep disorder for which sleep restriction may be contraindicated is present (e.g., restless leg syndrome, sleep apnea, or sleep problems that are exclusively related to shift work)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Online Therapy Unit, University of Regina
Regina, Saskatchewan, S4S 0A2
About this study
Official title: Treating Comorbid Insomnia in Patients Receiving Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy for Anxiety and Depression: A Randomized Controlled Trial
Transdiagnostic Internet-delivered Cognitive Behaviour Therapy (ICBT) is an efficacious treatment option for anxiety and depression; however, not all patients benefit equally and some leave treatment before program completion. Comorbid symptoms of insomnia are extremely common among individuals seeking ICBT, yet sleep problems are rarely a primary focus of treatment in transdiagnostic ICBT despite insomnia being a known risk factor for anxiety and depression. This trial is designed to test whether an ICBT program for anxiety and depression can be improved by providing therapy for insomnia alongside the standard transdiagnostic program. For this randomized controlled trial, patients will be randomly assigned to receive either the standard ICBT program for anxiety and depression, which includes only brief supplementary information about sleep (n = 68), or a modified version that includes a lesson specifically on sleep (n = 132). The sleep lesson will introduce patients to two key behavioural strategies: sleep restriction and stimulus control, which previous research has demonstrated are effective at reducing insomnia. Patients will monitor their sleep throughout treatment and will complete measures of insomnia, anxiety and depression before treatment, at the end of the 8-week program, and 3 months after program conclusion to allow for a comparison of patient outcomes and completion rates between conditions. The acceptability of the new intervention will also be assessed by asking participants to provide feedback on the new materials and to complete measures of treatment satisfaction and working alliance.
- Conditions
- Insomnia, Anxiety, Depression
- Being tested
- Transdiagnostic Internet-delivered Cognitive Behaviour Therapy, Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia
- Keywords
- Internet-delivered Cognitive Behaviour Therapy, Insomnia, Depression, Anxiety, Transdiagnostic
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic Internet-delivered Cognitive Behaviour TherapyBehavioural
All participants receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia. The course is comprised of 5 lessons, beginning with psychoeducation and an introduction to the cognitive behavioural model, and then introducing key skills for managing anxiety and depression, including thought challenging, de-arousal strategies, graded exposure, behavioural activation, and relapse prevention. The course also includes supplementary resources that briefly provide information on related common concerns, such as managing worry, communication, assertiveness, problem solving, and a brief resource on sleep that provides limited psychoeducation and sleep hygiene information. Participants receive weekly brief therapist support via secure message or telephone from qualified counselors (social workers, psychologists).
Brief Internet-Delivered Cognitive Behaviour Therapy for InsomniaBehavioural
A new sleep lesson will replace the existing resource, developed using a patient-oriented process, that provides information and skills to aid with insomnia. The sleep lesson includes psychoeducation on the nature of sleep problems and factors that affect sleep, such as circadian rhythm. Two key behavioural strategies are introduced: sleep restriction, which requires the patient to avoid napping and sleep on a strict schedule for several weeks until they begin to feel naturally sleepy at night; and stimulus control, which asks the participant to only spend time in bed when prepared to sleep and avoid other activities (e.g., work, TV) in bed. Patients will record how much they sleep each night and provide ratings of sleep quality and fatigue each week. Therapists will support patients in adjusting their sleep schedule. Patients are encouraged to apply skills they learn during the Wellbeing Course to sleep problems, for example, by applying thought challenging to beliefs about sleep.
| Study group | Role | What they receive |
|---|---|---|
| Standard ICBT | Active comparator | Participants in the Standard ICBT condition will receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia. Receives: Behavioral: Transdiagnostic Internet-delivered Cognitive Behaviour Therapy |
| Sleep-Enhanced ICBT | Experimental | Participants in the Sleep-Enhanced ICBT condition will receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia. In addition, participants in the Sleep-Enhanced ICBT condition will also receive a newly developed lesson designed to target insomnia. Receives: Behavioral: Transdiagnostic Internet-delivered Cognitive Behaviour Therapy; Behavioral: Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
Change in insomnia symptoms from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The ISI is a brief measure of insomnia comprised of 7 questions that ask about difficulties falling asleep, staying asleep, and waking too early, which respondents answer on a scale from 0 (None) to 4 (Very Severe), producing a score between 0 and 28.
Measured: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Patient Health Questionnaire 9-item (PHQ-9)
Change in depression symptoms from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The PHQ-9 is a 9-item self-report measure of symptoms of depression that produces a total depression severity score ranging from 0-27.
Measured: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Generalized Anxiety Disorder (GAD-7)
Change in anxiety symptom from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The GAD-7 is a 7-item self-report measure of symptoms of anxiety that produces a total anxiety severity score ranging from 0-21.
Measured: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Secondary outcomes (4)
Panic Disorder Severity Scale (PDSS)
Change in symptoms of panic. The PDSS is a 7-item measure of common symptoms of panic disorder. Respondents answer each item on a 0-4 scale, producing a total score between 0 and 28.
Measured: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Social Interaction Anxiety Scale and Social Phobia Scale - Short Form (SIAS-6/SPS-6)
Change in symptoms of social anxiety. The SIAS-6/SPS-6 includes 12 items related to common symptoms of social anxiety that are summed to create a total score.
Measured: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Treatment Satisfaction
A treatment satisfaction questionnaire that includes questions about the patient's opinion of the program and the working alliance they developed with their therapist. Patients will also be asked whether they would recommend the treatment to others. Patients will then complete the Working Alliance Inventory-Short a 12-item measure of the therapeutic alliance.
Measured: Week 8 (post-treatment)
Lesson Completion
The program website will record when patients access each lesson, providing a way to calculate the proportion of patients who complete each lesson and treatment overall.
Measured: Ongoing throughout treatment (Weeks 1-8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start9 Sep 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Centre for Patient-Oriented Research
- Responsible party
- Sponsor
- Investigators
- Michael Edmonds, MA, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512768
- Sponsor's protocol ID
- 2019-204
- Status last verified
- Sep 2022
- First submitted
- 4 Aug 2020
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researchers may ask to review IPD from this trial following completion of data collection. For the purposes of meta-analyses or other legitimate uses, IPD will be provided after being fully de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Comorbid Insomnia in Patients Receiving Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy for Anxiety and Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04512768
- Acronym / sponsor ID
- 2019-204
- Conditions
- Insomnia, Anxiety, Depression
- Keywords
- Internet-delivered Cognitive Behaviour Therapy, Insomnia, Depression, Anxiety, Transdiagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Saskatchewan Centre for Patient-Oriented Research
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 14 Aug 2020 (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.
Transdiagnostic Internet-delivered Cognitive Behaviour Therapy (ICBT) is an efficacious treatment option for anxiety and depression; however, not all patients benefit equally and some leave treatment before program completion. Comorbid symptoms of insomnia are extremely common among individuals seeking ICBT, yet sleep problems are rarely a primary focus of treatment in transdiagnostic ICBT despite insomnia being a known risk factor for anxiety and depression. This trial is designed to test whether an ICBT program for anxiety and depression can be improved by providing therapy for insomnia alongside the standard transdiagnostic program. For this randomized controlled trial, patients will be randomly assigned to receive either the standard ICBT program for anxiety and depression, which includes only brief supplementary information about sleep (n = 68), or a modified version that includes a lesson specifically on sleep (n = 132). The sleep lesson will introduce patients to two key behavioural strategies: sleep restriction and stimulus control, which previous research has demonstrated are effective at reducing insomnia. Patients will monitor their sleep throughout treatment and will complete measures of insomnia, anxiety and depression before treatment, at the end of the 8-week program, and 3 months after program conclusion to allow for a comparison of patient outcomes and completion rates between conditions. The acceptability of the new intervention will also be assessed by asking participants to provide feedback on the new materials and to complete measures of treatment satisfaction and working alliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard ICBT | Active comparator | Behavioral: Transdiagnostic Internet-delivered Cognitive Behaviour TherapyParticipants in the Standard ICBT condition will receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia. |
| Sleep-Enhanced ICBT | Experimental | Behavioral: Transdiagnostic Internet-delivered Cognitive Behaviour Therapy, Behavioral: Brief Internet-Delivered Cognitive Behaviour Therapy for InsomniaParticipants in the Sleep-Enhanced ICBT condition will receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia. In addition, participants in the Sleep-Enhanced ICBT condition will also receive a newly developed lesson designed to target insomnia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must reside in Saskatchewan
- Participants must have access to a computer and feel comfortable using the internet
- Participants must be willing to provide a medical contact (e.g., family doctor) in case of medical emergency
- Participants must endorse some symptoms of anxiety or depression
- Participants must also endorse significant symptoms of insomnia (Insomnia Severity Index score of 10 or above)
Key exclusion criteria (4 listed)
- High risk of suicide
- Unmanaged severe psychiatric illness (e.g., psychosis, mania)
- Severe alcohol or addictions problems that require referral
- High probability that another sleep disorder for which sleep restriction may be contraindicated is present (e.g., restless leg syndrome, sleep apnea, or sleep problems that are exclusively related to shift work)
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 |
|---|---|---|
| Transdiagnostic Internet-delivered Cognitive Behaviour TherapyAll participants receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia. The course is comprised of 5 lessons, beginning with psychoeducation and an introduction to the cognitive behavioural model, and then introducing key skills for managing anxiety and depression, including thought challenging, de-arousal strategies, graded exposure, behavioural activation, and relapse prevention. The course also includes supplementary resources that briefly provide information on related common concerns, such as managing worry, communication, assertiveness, problem solving, and a brief resource on sleep that provides limited psychoeducation and sleep hygiene information. Participants receive weekly brief therapist support via secure message or telephone from qualified counselors (social workers, psychologists). | Behavioural | Sleep-Enhanced ICBT, Standard ICBT |
| Brief Internet-Delivered Cognitive Behaviour Therapy for InsomniaA new sleep lesson will replace the existing resource, developed using a patient-oriented process, that provides information and skills to aid with insomnia. The sleep lesson includes psychoeducation on the nature of sleep problems and factors that affect sleep, such as circadian rhythm. Two key behavioural strategies are introduced: sleep restriction, which requires the patient to avoid napping and sleep on a strict schedule for several weeks until they begin to feel naturally sleepy at night; and stimulus control, which asks the participant to only spend time in bed when prepared to sleep and avoid other activities (e.g., work, TV) in bed. Patients will record how much they sleep each night and provide ratings of sleep quality and fatigue each week. Therapists will support patients in adjusting their sleep schedule. Patients are encouraged to apply skills they learn during the Wellbeing Course to sleep problems, for example, by applying thought challenging to beliefs about sleep. | Behavioural | Sleep-Enhanced ICBT |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Change in insomnia symptoms from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The ISI is a brief measure of insomnia comprised of 7 questions that ask about difficulties falling asleep, staying asleep, and waking too early, which respondents answer on a scale from 0 (None) to 4 (Very Severe), producing a score between 0 and 28.
Patient Health Questionnaire 9-item (PHQ-9)
Time frame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Change in depression symptoms from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The PHQ-9 is a 9-item self-report measure of symptoms of depression that produces a total depression severity score ranging from 0-27.
Generalized Anxiety Disorder (GAD-7)
Time frame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Change in anxiety symptom from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The GAD-7 is a 7-item self-report measure of symptoms of anxiety that produces a total anxiety severity score ranging from 0-21.
4 secondary outcomes
Panic Disorder Severity Scale (PDSS)
Time frame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Social Interaction Anxiety Scale and Social Phobia Scale - Short Form (SIAS-6/SPS-6)
Time frame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Treatment Satisfaction
Time frame: Week 8 (post-treatment)
Lesson Completion
Time frame: Ongoing throughout treatment (Weeks 1-8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: Yes. Other researchers may ask to review IPD from this trial following completion of data collection. For the purposes of meta-analyses or other legitimate uses, IPD will be provided after being fully de-identified.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
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.
Michael Edmonds, MA principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic Internet-delivered Cognitive Behaviour Therapy and Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia in people with Insomnia and Anxiety, run by University of Regina 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 4 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: finished, as of the sponsor's last update on 22 Sep 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insomnia Severity Index (ISI) (time frame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)). 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 22 Sep 2022.