CBT Depression Intervention for Co-Occurring Chronic Headache

NCT02870725 | Completed

• 1 other identifier: 002322
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Depression; Headaches Chronic; Migraine Disorders

Keywords

chronic headaches, migraines, depression

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Mean change in "Migraine Disability Assessement Questionnaire (MIDAS)"

  Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up

• Mean change in "Headache Management Self-Efficacy Scale Adapted for Recurrent Headaches (HSES)"

  Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up

• Mean change in "Headache Specific Locus of Control (HSLoC)"

  Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up

Study Arms (2)

Control Group (Treatment As Usual)

NO INTERVENTION

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.

CBT Individual Psychotherapy (Treatment)

EXPERIMENTAL

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.

Behavioral: CBT Individual Psychotherapy

Interventions

CBT Individual Psychotherapy BEHAVIORAL

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.

CBT Individual Psychotherapy (Treatment)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Georgia: lead
• Henry Ford Health System: collaborator

Study Sites (2)

University of Georgia

Athens, Michigan, 30601, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (14)

• 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.

  PMID: 17034402 BACKGROUND

• 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.

  PMID: 23695037 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

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

  PMID: 18549359 BACKGROUND

• 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.

  PMID: 17727471 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12707434 RESULT

• 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.

  PMID: 19216763 RESULT

• Frediani F, Villani V. Migraine and depression. Neurol Sci. 2007 May;28 Suppl 2:S161-5. doi: 10.1007/s10072-007-0771-7.

  PMID: 17508165 RESULT

• Hamelsky SW, Lipton RB. Psychiatric comorbidity of migraine. Headache. 2006 Oct;46(9):1327-33. doi: 10.1111/j.1526-4610.2006.00576.x.

  PMID: 17040330 RESULT

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

  RESULT

• 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.

  RESULT

• 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.

  PMID: 21457242 RESULT

MeSH Terms

Conditions

Depression; Headache Disorders; Migraine Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary

Study Officials

• Bernadette D Heckman, PhD

  University of Georiga

  STUDY CHAIR

• Benilda P Pooser

  University of Georgia, VP office for research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: August 17, 2016
• Study Start: November 1, 2016
• Primary Completion: June 22, 2017
• Study Completion: July 1, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)