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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-Behavioral Therapy | Other | Intervention for Sleep and Pain in Youth, a 7-session cognitive-behavioral therapy intervention for co-morbid insomnia and headache |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention for Sleep and Pain in Youth | Behavioral | See arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Intervention Delivery: Number of Completed Intervention Visits | Number of completed intervention visits | 6-12 weeks |
| Feasibility of Intervention Delivery: Recruitment/Enrollment Rate | Recruitment/Enrollment Rate | 6-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Insomnia Severity Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Law, PhD | University of Washington & Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Research Institute | Seattle | Washington | 98122 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27923435 | Background | 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. | |
| 24796681 | Background | Eccleston 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;(5):CD003968. doi: 10.1002/14651858.CD003968.pub4. |
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| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D008881 | Migraine Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D051270 | Headache Disorders, Primary |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D012890 | Sleep |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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7-item self-report measure of insomnia severity and impact, scores range from 0-28 with higher scores indicating greater insomnia symptoms. |
| 3 months |
| Adolescent Sleep Wake Scale | 28-item measure of subjective sleep quality, scores range from 28-168, higher scores indicate poorer sleep quality | Past 4 weeks |
| Pain Questionnaire | Assesses pain frequency, intensity, onset, and duration. | Past 2 weeks |
| Child Activity Limitations Interview | Assesses pain-related disability | Past month |
| 24484373 | Background | Fales 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. |
| 23031311 | Background | Palermo 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. |
| 21030151 | Background | Palermo 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. |
| 30152164 | Derived | Law 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. |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |