CBT Depression Intervention for Co-Occurring Chronic Headache

July 3, 2017 updated by: Ashley J. Britton, University of Georgia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Athens, Michigan, United States, 30601
        • University of Georgia
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up
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.
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)"
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
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)"
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.
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)"
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.
Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Georgia

Collaborators

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

June 22, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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