CBT Depression Intervention for Co-Occurring Chronic Headache

Depression Clinical Trial

Official title:

A Cognitive Behavioral Therapy (CBT) Depression Intervention in Persons With Co-Occurring Chronic Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870725
• Other study ID #: 002322
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: July 3, 2017
• Start date: November 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: July 2017
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Having co-occurring depression and chronic headaches is challenging and can greatly impact one's professional, personal, family, and social life. People living with chronic headaches are often at a greater risk of having comorbid psychiatric disorders (depression, anxiety), reduced quality of life, and impaired functioning because of under-diagnosis, misdiagnosis or under-treatment of both chronic conditions.

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.

Description:

STUDY LOCATIONS:

(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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 1, 2017
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18-75 years of age & living in GA or MI;

• 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:

• outside of 18-75 year old age range;

• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Headache
• Headache Disorders
• Headaches Chronic
• Migraine Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Michigan
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Georgia	Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (14)

Baskin SM, Lipchik GL, Smitherman TA. Mood and anxiety disorders in chronic headache. Headache. 2006 Oct;46 Suppl 3:S76-87. Review. — View Citation

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. — View Citation

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 — View Citation

Frediani F, Villani V. Migraine and depression. Neurol Sci. 2007 May;28 Suppl 2:S161-5. Review. — View Citation

Hamelsky SW, Lipton RB. Psychiatric comorbidity of migraine. Headache. 2006 Oct;46(9):1327-33. — View Citation

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.

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.

Nimnuan C., & Srikiatkhachorn A. Migraine: Psychiatric comorbidities. Retrieved January 25, 2015, from http://www.medmerits.com/index.php/article/migraine_psychiatric_comorbidities, 2011.

Sammons M. Treatment of head pain with psychotropics. Professional Psychology: Research and Practice, 36(6): 611-614, 2005.

Saper JR. Pearls from an inpatient headache unit. Headache. 2008 Jun;48(6):820-7. doi: 10.1111/j.1526-4610.2008.01141.x. Review. — View Citation

Shapiro R, Goadsby P. The long drought: the dearth of public funding for headache research. Cephalalgia. 2007 Sep;27(9):991-4. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in "Beck Depression Inventory (BDI-2)"	A 21-item likert scale developed to assess the intensity of depression while also monitoring changes over time.	Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
Primary	Mean change in "Headache Disability Index"	A 27-item measure that assesses the impact of headache on daily living, headache treatment and the level of disability experienced.	Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
Secondary	Mean change in "Migraine Disability Assessement Questionnaire (MIDAS)"	A 7-item questionnaire developed to assess the severity of disability related to migraines within the past 3 months, in 3 domains: school/paid work, household chores, & family/social/leisure activities	Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
Secondary	Mean change in "Headache Management Self-Efficacy Scale Adapted for Recurrent Headaches (HSES)"	A 25-item likert scale developed for recurrent headache sufferers to assess an individual's self-efficacy in preventing their headaches.	Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
Secondary	Mean change in "Headache Specific Locus of Control (HSLoC)"	A 33-item Likert scale designed to assess an individual's perceptions (locus of control) about their headache problems and headache relief on 3 dimensions: individual behavior (internal factor), healthcare professionals (external factor), or chance factors.	Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up