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NCT Number: NCT02870725

CBT Depression Intervention for 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Headaches Chronic Migraine Disorders Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Georgia, Athens, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT Individual Psychotherapy

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Collaborators

  • Henry Ford Health System

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 17, 2016
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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