CBT Depression Intervention for Co-Occurring Chronic Headache
NCT ID: NCT02870725
Last Updated: 2017-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2016-11-30
2017-07-01
Brief Summary
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This study is a pilot clinical trial that will compare the effectiveness of a brief cognitive-behavior therapy (CBT) depression intervention to a care as usual (control) group. The aim of the study is to determine how well the CBT intervention will reduce the frequency, severity and level of disability of both the headaches and depression symptoms.
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Detailed Description
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(A) University of Georgia College of Education in Athens, GA
(B) Henry Ford Hospital - Main campus in Detroit, MI.
* For the MI participants, you must be willing to travel to Detroit for the intervention if you choose to participate and are assigned to the treatment group.
\*\*Please contact me with any questions about the study.\*\*
Background: This research focuses on emphasizing alternative treatment approaches to underserved and marginalized groups. This study is a randomized pilot intervention to treat a community sample with co-occurring depression and chronic pain (i.e. headaches/migraines) - since they are at an increased risk for impaired functioning, comorbid psychiatric disorders and reduced quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group (Treatment As Usual)
Individuals randomized into the control condition will not receive any active treatment but will have access to customary, community-based supportive services. These individuals will complete the pre-, post- and 4-week post-intervention outcome assessment measures and will serve as a means of comparison for those in the other arm of the study.
No interventions assigned to this group
CBT Individual Psychotherapy (Treatment)
Behavioral Intervention (Individual Psychotherapy). These individuals will complete the pre-, post- and 4-week post-intervention outcome assessment measures and will serve as a means of determining whether or not the intervention was effective compared to the control arm.
CBT Individual Psychotherapy
The 4-session CBT treatment will include receipt of a manualized cognitive behavioral intervention, delivered individually, to treat the depression symptoms (e.g. cognitive restructuring, behavioral activation) and teach adaptive coping strategies to manage their depression. Ideally, the intervention will also positively affect their chronic headaches (i.e. reduction of headache frequency, severity and level of disability). Each session is approximately 60 minutes with specific, reflective and guided activities related to a specific module within the intervention.
Interventions
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CBT Individual Psychotherapy
The 4-session CBT treatment will include receipt of a manualized cognitive behavioral intervention, delivered individually, to treat the depression symptoms (e.g. cognitive restructuring, behavioral activation) and teach adaptive coping strategies to manage their depression. Ideally, the intervention will also positively affect their chronic headaches (i.e. reduction of headache frequency, severity and level of disability). Each session is approximately 60 minutes with specific, reflective and guided activities related to a specific module within the intervention.
Eligibility Criteria
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Inclusion Criteria
* a PHQ-9 score ≥5; AND
* have frequent migraines and/or moderate to severe headaches = 10 or more headache days per month for the past 3 months
* May or may not be taking headache/migraine medication so long as still meet other criteria
* \*\* For MI participants: must be willing \& able to come to Detroit campus for the intervention (4 weeks in a row)
Exclusion Criteria
* Do not live in GA or MI
* Unable or unwilling to drive to campus location for the 4 sessions (treatment group only)
* do not have both conditions of depression and frequent/near-chronic headaches
* Active suicidal ideation (detailed plan and/or access to lethal means) or suicide attempts within the past 60 days.
18 Years
75 Years
ALL
No
Sponsors
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Henry Ford Health System
OTHER
University of Georgia
OTHER
Responsible Party
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Ashley J. Britton
Doctoral Candidate
Principal Investigators
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Bernadette D Heckman, PhD
Role: STUDY_CHAIR
University of Georiga
Benilda P Pooser
Role: STUDY_DIRECTOR
University of Georgia, VP office for research
Locations
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University of Georgia
Athens, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Countries
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References
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Baskin SM, Lipchik GL, Smitherman TA. Mood and anxiety disorders in chronic headache. Headache. 2006 Oct;46 Suppl 3:S76-87. doi: 10.1111/j.1526-4610.2006.00559.x.
Weeks RE. Application of behavioral therapies in adult and adolescent patients with chronic migraine. Neurol Sci. 2013 May;34 Suppl 1:S11-7. doi: 10.1007/s10072-013-1360-6.
Martin P., Meadows G., Piterman L., Sharman M., Reece J., & Milgrom J. Cognitive Behavioral Therapy Effective for Comorbid Chronic Headache, Depression. Retrieved December 23, 2014, from http://www.psychcongress.com/article/cognitive-behavioral-therapy-effective-comorbid-chronic-headache-depression-12514, 2013.
Nimnuan C., & Srikiatkhachorn A. Migraine: Psychiatric comorbidities. Retrieved January 25, 2015, from http://www.medmerits.com/index.php/article/migraine_psychiatric_comorbidities, 2011.
Saper JR. Pearls from an inpatient headache unit. Headache. 2008 Jun;48(6):820-7. doi: 10.1111/j.1526-4610.2008.01141.x.
Shapiro R, Goadsby P. The long drought: the dearth of public funding for headache research. Cephalalgia. 2007 Sep;27(9):991-4. doi: 10.1111/j.1468-2982.2007.01396.x. No abstract available.
Muñoz, R. & Miranda, J. (1986, Revised 1993). Group Therapy Manual for Cognitive-behavioral Treatment of Depression. San Francisco General Hospital, Depression Clinic. Available from the author. University of California, San Francisco, Department of Psychiatry, San Francisco General Hospital, 1001 Potrero Avenue, Suite 7M, San Francisco, CA 94110.
Breslau N, Lipton RB, Stewart WF, Schultz LR, Welch KM. Comorbidity of migraine and depression: investigating potential etiology and prognosis. Neurology. 2003 Apr 22;60(8):1308-12. doi: 10.1212/01.wnl.0000058907.41080.54.
Castien RF, van der Windt DA, Dekker J, Mutsaers B, Grooten A. Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: design of a randomised clinical trial. BMC Musculoskelet Disord. 2009 Feb 12;10:21. doi: 10.1186/1471-2474-10-21.
Frediani F, Villani V. Migraine and depression. Neurol Sci. 2007 May;28 Suppl 2:S161-5. doi: 10.1007/s10072-007-0771-7.
Hamelsky SW, Lipton RB. Psychiatric comorbidity of migraine. Headache. 2006 Oct;46(9):1327-33. doi: 10.1111/j.1526-4610.2006.00576.x.
Sammons M. Treatment of head pain with psychotropics. Professional Psychology: Research and Practice, 36(6): 611-614, 2005.
Shulman, R. (2013, May 17). Psychiatric Aspects of Headache, Pain and Depression [Webinar]. In National Headache Foundation Webinar Series. Retrieved January 30, 2015 from https://www.youtube.com/watch?v=4n3BTs6-fFU&list=PL6bpjkbYtk-MBnNjRF7pAxzBJI52_XdPd.
Smitherman TA, McDermott MJ, Buchanan EM. Negative impact of episodic migraine on a university population: quality of life, functional impairment, and comorbid psychiatric symptoms. Headache. 2011 Apr;51(4):581-9. doi: 10.1111/j.1526-4610.2011.01857.x.
Other Identifiers
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002322
Identifier Type: -
Identifier Source: org_study_id
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