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CBT Depression Intervention for Co-Occurring Chronic Headache

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ClinicalTrials.gov Identifier: NCT02870725
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
Henry Ford Health System
Information provided by (Responsible Party):
Ashley J. Britton, 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.


Condition or disease Intervention/treatment Phase
Depression Headaches Chronic Migraine Disorders Behavioral: CBT Individual Psychotherapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
United States, Michigan
University of Georgia
Athens, Michigan, United States, 30601
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
University of Georgia
Henry Ford Health System
Investigators
Study Chair: Bernadette D Heckman, PhD University of Georiga
Study Director: Benilda P Pooser University of Georgia, VP office for research

Publications of Results:
Other Publications:
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.
Nimnuan C., & Srikiatkhachorn A. Migraine: Psychiatric comorbidities. Retrieved January 25, 2015, from http://www.medmerits.com/index.php/article/migraine_psychiatric_comorbidities, 2011.
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.

Responsible Party: Ashley J. Britton, Doctoral Candidate, University of Georgia
ClinicalTrials.gov Identifier: NCT02870725     History of Changes
Other Study ID Numbers: 002322
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Keywords provided by Ashley J. Britton, University of Georgia:
chronic headaches, migraines, depression

Additional relevant MeSH terms:
Depressive Disorder
Migraine Disorders
Headache
Headache Disorders
Mood Disorders
Mental Disorders
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Depression
Behavioral Symptoms
Pain
Neurologic Manifestations
Signs and Symptoms