Clinical trial NCT02870725: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Headaches Chronic
Migraine Disorders
Keywords: chronic headaches, migraines, depression
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: Henry Ford Health System
First posted: 2016-08-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean change in "Beck Depression Inventory (BDI-2)"
timeFrame: Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
measure: Mean change in "Headache Disability Index"
timeFrame: Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
Secondary outcomes:
measure: Mean change in "Migraine Disability Assessement Questionnaire (MIDAS)"
timeFrame: Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
measure: Mean change in "Headache Management Self-Efficacy Scale Adapted for Recurrent Headaches (HSES)"
timeFrame: Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
measure: Mean change in "Headache Specific Locus of Control (HSLoC)"
timeFrame: Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: University of Georiga
name: Bernadette D Heckman, PhD
role: STUDY_CHAIR
affiliation: University of Georgia, VP office for research
name: Benilda P Pooser
role: STUDY_DIRECTOR
References:
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