CBT Depression Intervention for Co-Occurring Chronic Headache
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02870725|
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : July 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Headaches Chronic Migraine Disorders||Behavioral: CBT Individual Psychotherapy||Not Applicable|
(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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Cognitive Behavioral Therapy (CBT) Depression Intervention in Persons With Co-Occurring Chronic Headache|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||June 22, 2017|
|Actual Study Completion Date :||July 1, 2017|
No Intervention: Control Group (Treatment As Usual)
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)
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
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.
- Mean change in "Beck Depression Inventory (BDI-2)" [ Time Frame: 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" [ Time Frame: 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.
- Mean change in "Migraine Disability Assessement Questionnaire (MIDAS)" [ Time Frame: 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)" [ Time Frame: 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)" [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870725
|United States, Michigan|
|University of Georgia|
|Athens, Michigan, United States, 30601|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|Study Chair:||Bernadette D Heckman, PhD||University of Georiga|
|Study Director:||Benilda P Pooser||University of Georgia, VP office for research|