Headache DisordersI-SPYNCT03137147
Intervention for Sleep and Pain in Youth
A study testing Intervention for Sleep and Pain in Youth in people with Headache Disorders and Migraine Disorders, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
This study tests the feasibility, acceptability, and preliminary efficacy of a seven-session cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages 11-17 with co-morbid headache and insomnia. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Headache Disorders, Migraine Disorders, Insomnia
- What is being tested?
- Intervention for Sleep and Pain in Youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 30 Dec 2017
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- youth age 11-17 years
- chronic headache and insomnia symptoms for the past 3 months as determined on screening interview with youth and parent.
Who cannot join
- youth and parent do not read or speak English
- youth with active suicidal ideation or psychosis
- youth with diagnosis of a comorbid serious health condition (e.g., cancer, diabetes)
- youth with severe cognitive impairment
- youth with another primary sleep disorder (e.g., sleep apnea, narcolepsy) or an unusual sleep/wake schedule or circadian rhythm disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98122
About this study
Official title: Intervention for Sleep and Pain in Youth: A Feasibility Study of Cognitive-Behavioral Intervention
This study tests the feasibility, acceptability, and preliminary efficacy of a seven-session cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages 11-17 with co-morbid headache and insomnia.
Read the detailed description
Cognitive-behavioral interventions have been developed to treat childhood insomnia and childhood headache. In this study, we have combined strategies from these interventions into a single, seven-session protocol to treat sleep and pain problems in youth with co-morbid headache and insomnia. In this single-arm pilot study, we will test the feasibility, acceptability, and preliminary efficacy of this intervention.
- Conditions
- Headache Disorders, Migraine Disorders, Insomnia
- Being tested
- Intervention for Sleep and Pain in Youth
- Keywords
- pediatric, children, adolescent, sleep, pain, cognitive-behavioral therapy
- Medical subject headings
- Headache Disorders, Migraine Disorders, Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention for Sleep and Pain in YouthBehavioural
Also called Hybrid cognitive behavioral therapy for insomnia and headache
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy | Other | Intervention for Sleep and Pain in Youth, a 7-session cognitive-behavioral therapy intervention for co-morbid insomnia and headache Receives: Behavioral: Intervention for Sleep and Pain in Youth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Delivery: Number of Completed Intervention Visits
Number of completed intervention visits
Measured: 6-12 weeks
Feasibility of Intervention Delivery: Recruitment/Enrollment Rate
Recruitment/Enrollment Rate
Measured: 6-12 weeks
Secondary outcomes (5)
Treatment Acceptability and Satisfaction: Treatment Evaluation Inventory Short Form
9-item self-report measure of treatment acceptability and satisfaction, scores range from 9-45, higher scores indicate greater treatment acceptability
Measured: 3 months
Insomnia Severity Index
7-item self-report measure of insomnia severity and impact, scores range from 0-28 with higher scores indicating greater insomnia symptoms.
Measured: 3 months
Adolescent Sleep Wake Scale
28-item measure of subjective sleep quality, scores range from 28-168, higher scores indicate poorer sleep quality
Measured: Past 4 weeks
Pain Questionnaire
Assesses pain frequency, intensity, onset, and duration.
Measured: Past 2 weeks
Child Activity Limitations Interview
Assesses pain-related disability
Measured: Past month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 Oct 2016
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Law, Seattle Children's Hospital
- Investigators
- Emily Law, PhD, Principal investigator, University of Washington & Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137147
- Sponsor's protocol ID
- STUDY00000002
- Acronym
- I-SPY
- Status last verified
- Apr 2018
- First submitted
- 24 Apr 2017
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Palermo TM, Beals-Erickson S, Bromberg M, Law E, Chen M. A Single Arm Pilot Trial of Brief Cognitive Behavioral Therapy for Insomnia in Adolescents with Physical and Psychiatric Comorbidities. J Clin Sleep Med. 2017 Mar 15;13(3):401-410. doi: 10.5664/jcsm.6490.
PubMed 27923435Eccleston C, Palermo TM, Williams AC, Lewandowski Holley A, Morley S, Fisher E, Law E. Psychological therapies for the management of chronic and recurrent pain in children and adolescents. Cochrane Database Syst Rev. 2014 May 5;2014(5):CD003968. doi: 10.1002/14651858.CD003968.pub4.
PubMed 24796681Fales J, Palermo TM, Law EF, Wilson AC. Sleep outcomes in youth with chronic pain participating in a randomized controlled trial of online cognitive-behavioral therapy for pain management. Behav Sleep Med. 2015;13(2):107-23. doi: 10.1080/15402002.2013.845779. Epub 2014 Jan 31.
PubMed 24484373Palermo TM, Law E, Churchill SS, Walker A. Longitudinal course and impact of insomnia symptoms in adolescents with and without chronic pain. J Pain. 2012 Nov;13(11):1099-106. doi: 10.1016/j.jpain.2012.08.003. Epub 2012 Sep 30.
PubMed 23031311Palermo TM, Wilson AC, Lewandowski AS, Toliver-Sokol M, Murray CB. Behavioral and psychosocial factors associated with insomnia in adolescents with chronic pain. Pain. 2011 Jan;152(1):89-94. doi: 10.1016/j.pain.2010.09.035. Epub 2010 Oct 27.
PubMed 21030151Law EF, Wan Tham S, Aaron RV, Dudeney J, Palermo TM. Hybrid Cognitive-Behavioral Therapy Intervention for Adolescents With Co-Occurring Migraine and Insomnia: A Single-Arm Pilot Trial. Headache. 2018 Jul;58(7):1060-1073. doi: 10.1111/head.13355.
PubMed 30152164
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Sleep and Pain in Youth: A Feasibility Study of Cognitive-Behavioral Intervention
- ClinicalTrials.gov ID
- NCT03137147
- Acronym / sponsor ID
- I-SPY / STUDY00000002
- Conditions
- Headache Disorders, Migraine Disorders, Insomnia
- Keywords
- pediatric, children, adolescent, sleep, pain, cognitive-behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 2 May 2017 (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.
This study tests the feasibility, acceptability, and preliminary efficacy of a seven-session cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages 11-17 with co-morbid headache and insomnia.
Detailed description
Cognitive-behavioral interventions have been developed to treat childhood insomnia and childhood headache. In this study, we have combined strategies from these interventions into a single, seven-session protocol to treat sleep and pain problems in youth with co-morbid headache and insomnia. In this single-arm pilot study, we will test the feasibility, acceptability, and preliminary efficacy of this intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy | Other | Behavioral: Intervention for Sleep and Pain in YouthIntervention for Sleep and Pain in Youth, a 7-session cognitive-behavioral therapy intervention for co-morbid insomnia and headache |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- youth age 11-17 years
- chronic headache and insomnia symptoms for the past 3 months as determined on screening interview with youth and parent.
Key exclusion criteria (5 listed)
- youth and parent do not read or speak English
- youth with active suicidal ideation or psychosis
- youth with diagnosis of a comorbid serious health condition (e.g., cancer, diabetes)
- youth with severe cognitive impairment
- youth with another primary sleep disorder (e.g., sleep apnea, narcolepsy) or an unusual sleep/wake schedule or circadian rhythm disorder.
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 |
|---|---|---|
| Intervention for Sleep and Pain in YouthAlso: Hybrid cognitive behavioral therapy for insomnia and headacheSee arm description. | Behavioural | Cognitive-Behavioral Therapy |
Primary outcome
Feasibility of Intervention Delivery: Number of Completed Intervention Visits
Time frame: 6-12 weeks
Number of completed intervention visits
Feasibility of Intervention Delivery: Recruitment/Enrollment Rate
Time frame: 6-12 weeks
Recruitment/Enrollment Rate
5 secondary outcomes
Treatment Acceptability and Satisfaction: Treatment Evaluation Inventory Short Form
Time frame: 3 months
Insomnia Severity Index
Time frame: 3 months
Adolescent Sleep Wake Scale
Time frame: Past 4 weeks
Pain Questionnaire
Time frame: Past 2 weeks
Child Activity Limitations Interview
Time frame: Past month
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 19 Apr 2018.
- Background: PubMed 27923435Palermo TM, Beals-Erickson S, Bromberg M, Law E, Chen M. A Single Arm Pilot Trial of Brief Cognitive Behavioral Therapy for Insomnia in Adolescents with Physical and Psychiatric Comorbidities. J Clin Sleep Med. 2017 Mar 15;13(3):401-410. doi: 10.5664/jcsm.6490.
- Background: PubMed 24796681Eccleston C, Palermo TM, Williams AC, Lewandowski Holley A, Morley S, Fisher E, Law E. Psychological therapies for the management of chronic and recurrent pain in children and adolescents. Cochrane Database Syst Rev. 2014 May 5;2014(5):CD003968. doi: 10.1002/14651858.CD003968.pub4.
- Background: PubMed 24484373Fales J, Palermo TM, Law EF, Wilson AC. Sleep outcomes in youth with chronic pain participating in a randomized controlled trial of online cognitive-behavioral therapy for pain management. Behav Sleep Med. 2015;13(2):107-23. doi: 10.1080/15402002.2013.845779. Epub 2014 Jan 31.
- Background: PubMed 23031311Palermo TM, Law E, Churchill SS, Walker A. Longitudinal course and impact of insomnia symptoms in adolescents with and without chronic pain. J Pain. 2012 Nov;13(11):1099-106. doi: 10.1016/j.jpain.2012.08.003. Epub 2012 Sep 30.
- Background: PubMed 21030151Palermo TM, Wilson AC, Lewandowski AS, Toliver-Sokol M, Murray CB. Behavioral and psychosocial factors associated with insomnia in adolescents with chronic pain. Pain. 2011 Jan;152(1):89-94. doi: 10.1016/j.pain.2010.09.035. Epub 2010 Oct 27.
- Derived from this study: PubMed 30152164Law EF, Wan Tham S, Aaron RV, Dudeney J, Palermo TM. Hybrid Cognitive-Behavioral Therapy Intervention for Adolescents With Co-Occurring Migraine and Insomnia: A Single-Arm Pilot Trial. Headache. 2018 Jul;58(7):1060-1073. doi: 10.1111/head.13355.
- Individual participant dataSharing planned: Undecided
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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.
Emily Law, PhD principal investigator
University of Washington & Seattle Children's 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 Intervention for Sleep and Pain in Youth in people with Headache Disorders and Migraine Disorders, run by Seattle Children's Hospital at 1 site in United States.
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 2 inclusion and 5 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 19 Apr 2018. 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 United States. 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?
Feasibility of Intervention Delivery: Number of Completed Intervention Visits (time frame: 6-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137147, which also lists 6 linked publications.
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 19 Apr 2018.