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CBT Depression Intervention for Co-Occurring Chronic Headache

Primary Purpose

Depression, Headaches Chronic, Migraine Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT Individual Psychotherapy
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring chronic headaches, migraines, depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Georgia
  • Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group (Treatment As Usual)

CBT Individual Psychotherapy (Treatment)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
February 2, 2016
Last Updated
July 3, 2017
Sponsor
University of Georgia
Collaborators
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02870725
Brief Title
CBT Depression Intervention for Co-Occurring Chronic Headache
Official Title
A Cognitive Behavioral Therapy (CBT) Depression Intervention in Persons With Co-Occurring Chronic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
June 22, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
Collaborators
Henry Ford Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Headaches Chronic, Migraine Disorders
Keywords
chronic headaches, migraines, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group (Treatment As Usual)
Arm Type
No Intervention
Arm Description
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.
Arm Title
CBT Individual Psychotherapy (Treatment)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT Individual Psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in "Beck Depression Inventory (BDI-2)"
Description
A 21-item likert scale developed to assess the intensity of depression while also monitoring changes over time.
Time Frame
Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
Title
Mean change in "Headache Disability Index"
Description
A 27-item measure that assesses the impact of headache on daily living, headache treatment and the level of disability experienced.
Time Frame
Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
Secondary Outcome Measure Information:
Title
Mean change in "Migraine Disability Assessement Questionnaire (MIDAS)"
Description
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
Time Frame
Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
Title
Mean change in "Headache Management Self-Efficacy Scale Adapted for Recurrent Headaches (HSES)"
Description
A 25-item likert scale developed for recurrent headache sufferers to assess an individual's self-efficacy in preventing their headaches.
Time Frame
Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
Title
Mean change in "Headache Specific Locus of Control (HSLoC)"
Description
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.
Time Frame
Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernadette D Heckman, PhD
Organizational Affiliation
University of Georiga
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Benilda P Pooser
Organizational Affiliation
University of Georgia, VP office for research
Official's Role
Study Director
Facility Information:
Facility Name
University of Georgia
City
Athens
State/Province
Michigan
ZIP/Postal Code
30601
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be available. Only the dummy coded data set will be shared between UGA and HFHS for statistical analysis. Results will be discussed from an aggregate data perspective.
Citations:
PubMed Identifier
17034402
Citation
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.
Results Reference
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PubMed Identifier
23695037
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.
Results Reference
background
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.
Results Reference
background
Citation
Nimnuan C., & Srikiatkhachorn A. Migraine: Psychiatric comorbidities. Retrieved January 25, 2015, from http://www.medmerits.com/index.php/article/migraine_psychiatric_comorbidities, 2011.
Results Reference
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PubMed Identifier
18549359
Citation
Saper JR. Pearls from an inpatient headache unit. Headache. 2008 Jun;48(6):820-7. doi: 10.1111/j.1526-4610.2008.01141.x.
Results Reference
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PubMed Identifier
17727471
Citation
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.
Results Reference
background
Citation
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.
Results Reference
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PubMed Identifier
12707434
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. doi: 10.1212/01.wnl.0000058907.41080.54.
Results Reference
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PubMed Identifier
19216763
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 12;10:21. doi: 10.1186/1471-2474-10-21.
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PubMed Identifier
17508165
Citation
Frediani F, Villani V. Migraine and depression. Neurol Sci. 2007 May;28 Suppl 2:S161-5. doi: 10.1007/s10072-007-0771-7.
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PubMed Identifier
17040330
Citation
Hamelsky SW, Lipton RB. Psychiatric comorbidity of migraine. Headache. 2006 Oct;46(9):1327-33. doi: 10.1111/j.1526-4610.2006.00576.x.
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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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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CBT Depression Intervention for Co-Occurring Chronic Headache

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