CBT Depression Intervention for Co-Occurring Chronic Headache
- Conditions
- DepressionMigraine DisordersHeadaches Chronic
- Interventions
- Behavioral: CBT Individual Psychotherapy
- Registration Number
- NCT02870725
- Lead Sponsor
- University of Georgia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CBT Individual Psychotherapy (Treatment) CBT Individual Psychotherapy 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.
- Primary Outcome Measures
Name Time Method Mean change in "Beck Depression Inventory (BDI-2)" Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up A 21-item likert scale developed to assess the intensity of depression while also monitoring changes over time.
Mean change in "Headache Disability Index" Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up A 27-item measure that assesses the impact of headache on daily living, headache treatment and the level of disability experienced.
- Secondary Outcome Measures
Name Time Method 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 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)" Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up 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)" Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up 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.
Trial Locations
- Locations (2)
University of Georgia
🇺🇸Athens, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States