CBT Depression Intervention for Co-Occurring Chronic Headache

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Headaches Chronic, Migraine Disorders

Intervention / Treatment
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* Behavioral: CBT Individual Psychotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group (Treatment As Usual)<br>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. | |
| Experimental: CBT Individual Psychotherapy (Treatment)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic headaches, migraines, depression