Insomnia Clinical Trial
Official title:
A Randomized Controlled Trial of Cognitive-behavioural Therapy for Insomnia (CBT-I) for Adolescents With Mild Traumatic Brain Injury
Verified date | September 2018 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A substantial number of children and adolescents sustain a mild traumatic brain injury (mTBI) each year. Although research supports that the vast majority of youth will recover quickly and return to normal functioning, some adolescents continue to report problems long after the injury. Disturbed sleep, notably trouble with sleep onset and sleep maintenance, is a frequently reported problem in those with slow recovery from a mTBI. Poor sleep is also associated with cognitive complaints, mood disturbance, and lower quality of life. Despite the identification of sleep disturbance as a problem associated with slow recovery, there are very few treatment options. Cognitive-behavioural therapy for insomnia (CBT-I) has shown promise in children and adolescents as an effective treatment for sleep disturbance, although it has yet to be applied to the adolescent mTBI population who also present with sleep problems. The objective of this study is to examine the treatment of sleep disturbance using cognitive-behavioural therapy for insomnia (CBT-I) in those adolescents who have a protracted recovery from their mTBI. This represents a novel treatment option for this patient population and is anticipated to improve outcomes and quality of life.
Status | Completed |
Enrollment | 24 |
Est. completion date | January 17, 2018 |
Est. primary completion date | January 17, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility |
Inclusion Criteria: - 12-18 years of age - diagnosed with a concussion by a nurse practitioner or physician at the ACH Complex Concussion Clinic (i.e., concussion was defined as an traumatic injury to the head, at least one reported symptom [e.g., dizziness, headache, nausea] at the time of the injury, and a Glasgow Coma Scale rating of =13/15 at 30 minutes after injury, or loss of consciousness <30 minutes, or post-traumatic amnesia <24 hours) - being at least 2 months but no more than 12 months post-injury to ensure symptoms were no longer acute, yet current and persistent - reporting elevated symptoms of insomnia measured by an Insomnia Severity Index score of =12 - ability to attend in-person treatment sessions. Exclusion Criteria: - moderate or severe TBI (i.e., Glasgow Coma scale rating of =12, loss of consciousness exceeding 30 minutes, and/or post-traumatic amnesia exceeding 24 hours) - visual, hearing, motor, and/or language deficits that would hinder the completion of questionnaires or engagement in CBT-I. |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Insomnia Severity Index (ISI) total score. | The ISI is a seven-item self-report questionnaire that assesses sleep onset latency, sleep efficiency, and functional impact from sleep issues. The sleep latency and efficiency items are rated on a 5-point Likert scale from 0 (none) to 4 (very severe). The remaining four items measure dissatisfaction, how noticeable sleep problems are to others, distress from sleep problems, and interference with daily functioning (all rated on 5-point Likert scales). Total scores on the ISI range from 0-28 with higher scores indicating more insomnia symptoms. | Baseline to post-treatment (7-weeks later) | |
Secondary | Insomnia Severity Index (ISI) total score. | The ISI is a seven-item self-report questionnaire that assesses sleep onset latency, sleep efficiency, and functional impact from sleep issues. The sleep latency and efficiency items are rated on a 5-point Likert scale from 0 (none) to 4 (very severe). The remaining four items measure dissatisfaction, how noticeable sleep problems are to others, distress from sleep problems, and interference with daily functioning (all rated on 5-point Likert scales). Total scores on the ISI range from 0-28 with higher scores indicating more insomnia symptoms. | Baseline to follow-up (4-weeks later) | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) Global Score | The PSQI is a widely used brief self-report measure of sleep quality aimed at examining the facets of sleep disturbance. It is composed of 19 items that measure sleep disruptions in the month prior to questionnaire completion. The PSQI contains seven subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction, which are combined into a total sleep quality score. The total PSQI raw score ranges from 0 to 21, with higher scores representing worse sleep disturbance; scores of greater than 5 indicate clinically significant sleep disruption. | Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) | |
Secondary | Dysfunctional Beliefs about Sleep (DBAS-16) total score | The DBAS was developed to identify unhelpful beliefs about sleep, and is composed of 16 items organized on an 11-point Likert scale that ranges from 0 (strongly disagree) to 10 (strongly agree). All item scores are summed and averaged to calculate a total raw score where higher scores indicate more negative beliefs and attitudes towards sleep. Scores range from 0-10. | Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) | |
Secondary | Total sleep time (TST) as assessed via 7-night sleep diary. | Participants completed an online sleep diary for the seven consecutive nights immediately following the completion of their questionnaire battery. Participants were asked to complete the sleep diary within an hour of waking up. The online sleep diary consisted of eight items assessing bedtime, duration of sleep initiation, night time waking, wake time, get-up time, nap time, and overall length and perceived quality of sleep.Across each of the 7-day assessment periods, average total sleep time (TST), wake after sleep onset (WASO), sleep onset latency (SOL) and sleep efficiency (SE) were calculated. | Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) | |
Secondary | Wake after sleep onset (WASO) as assessed via 7-night sleep diary | Participants completed an online sleep diary for the seven consecutive nights immediately following the completion of their questionnaire battery. Participants were asked to complete the sleep diary within an hour of waking up. The online sleep diary consisted of eight items assessing bedtime, duration of sleep initiation, night time waking, wake time, get-up time, nap time, and overall length and perceived quality of sleep.Across each of the 7-day assessment periods, average total sleep time (TST), wake after sleep onset (WASO), sleep onset latency (SOL) and sleep efficiency (SE) were calculated. | Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) | |
Secondary | Sleep onset latency (SOL) as assessed via 7-night sleep diary | Participants completed an online sleep diary for the seven consecutive nights immediately following the completion of their questionnaire battery. Participants were asked to complete the sleep diary within an hour of waking up. The online sleep diary consisted of eight items assessing bedtime, duration of sleep initiation, night time waking, wake time, get-up time, nap time, and overall length and perceived quality of sleep.Across each of the 7-day assessment periods, average total sleep time (TST), wake after sleep onset (WASO), sleep onset latency (SOL) and sleep efficiency (SE) were calculated. | Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) | |
Secondary | Sleep efficiency (SE) as assessed via 7-night sleep diary | Participants completed an online sleep diary for the seven consecutive nights immediately following the completion of their questionnaire battery. Participants were asked to complete the sleep diary within an hour of waking up. The online sleep diary consisted of eight items assessing bedtime, duration of sleep initiation, night time waking, wake time, get-up time, nap time, and overall length and perceived quality of sleep.Across each of the 7-day assessment periods, average total sleep time (TST), wake after sleep onset (WASO), sleep onset latency (SOL) and sleep efficiency (SE) were calculated. | Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) | |
Secondary | PROMIS® Depression Scale total score | The pediatric PROMIS® Depression questionnaire was developed by the NIH to evaluate symptoms of depression, such as feelings of hopelessness, helplessness, and worthlessness in pediatric populations. The self-report version of the PROMIS® Depression questionnaire was included in this study. This 8-item measure queries depression symptom presentation based on the past seven days, with each item rated on a 5-point Likert scale ranging from 1 (never) to 5 (almost always). All items were summed to calculate a total raw score where higher scores indicate more severe depressive mood. symptomology. | Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) | |
Secondary | PROMIS® Anxiety Scale total score | The pediatric PROMIS® Anxiety questionnaire was developed by the National Institutes of Health (NIH) to evaluate symptoms of anxiety, such as feelings of fear, anxious misery, and hyperarousal in pediatric populations. The self-report version of the PROMIS® Anxiety questionnaire was included in this study. This 8-item measure queries anxiety symptom presentation based on the past seven days, with each item rated on a 5-point Likert scale ranging from 1 (never) to 5 (almost always). All item scores were summed to calculate a total raw score where higher scores indicate more severe anxiety symptomology. | Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) | |
Secondary | Health and Behavior Inventory (HBI) total score | The Health and Behavior Inventory (HBI) was used to measure the presence and severity of post-concussive symptoms based on adolescent self-report. The HBI measures the frequency of common somatic and cognitive post-concussive complaints and does not include any sleep-related items. The HBI is a 20-item questionnaire where symptoms are rated on a 4-point Likert scale ranging from 1 (never) to 4 (often) based on frequency over the past week. All items were summed to calculate a total raw score where higher scores indicate more severe post-concussive symptoms. The HBI was developed as a measure for both child and parent-proxy reports of post-concussive symptoms in children. | Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT05963542 -
Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia
|
N/A | |
Completed |
NCT06339853 -
Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
|
N/A | |
Recruiting |
NCT04069247 -
Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia
|
N/A | |
Completed |
NCT04493593 -
Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility
|
N/A | |
Recruiting |
NCT05956886 -
Sleep Chatbot Intervention for Emerging Black/African American Adults
|
N/A | |
Recruiting |
NCT06278077 -
Neurexan - a Clinical Trial in Short-Term Insomnia Patients
|
Phase 2 | |
Completed |
NCT04661306 -
The Better Sleep for Supporters With Insomnia Study
|
N/A | |
Recruiting |
NCT06207279 -
Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
|
||
Recruiting |
NCT06006299 -
Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)
|
N/A | |
Completed |
NCT03683381 -
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
|
N/A | |
Completed |
NCT04564807 -
Testing an Online Insomnia Intervention
|
N/A | |
Completed |
NCT03673397 -
The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression
|
N/A | |
Completed |
NCT04035200 -
Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
|
Phase 2 | |
Active, not recruiting |
NCT05027438 -
Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention
|
N/A | |
Recruiting |
NCT06053840 -
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia
|
Phase 4 | |
Not yet recruiting |
NCT06348082 -
Project Women's Insomnia Sleep Health Equity Study (WISHES)
|
N/A | |
Not yet recruiting |
NCT06363799 -
Osteopathic Protocol for Insomnia in College Students
|
N/A | |
Not yet recruiting |
NCT06025968 -
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis
|
N/A | |
Not yet recruiting |
NCT05991492 -
Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
|
N/A |