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CBT Depression Intervention for Co-Occurring Chronic Headache

Primary Purpose

Depression, Headaches Chronic, Migraine Disorders

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBT Individual Psychotherapy

About this trial

This is an interventional treatment trial for Depression focused on measuring chronic headaches, migraines, depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Georgia
Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group (Treatment As Usual)

CBT Individual Psychotherapy (Treatment)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean change in "Beck Depression Inventory (BDI-2)"

A 21-item likert scale developed to assess the intensity of depression while also monitoring changes over time.

Mean change in "Headache Disability Index"

A 27-item measure that assesses the impact of headache on daily living, headache treatment and the level of disability experienced.

Secondary Outcome Measures

Mean change in "Migraine Disability Assessement Questionnaire (MIDAS)"

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)"

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)"

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.

Full Information

NCT ID

NCT02870725

First Posted

February 2, 2016

Last Updated

July 3, 2017

Sponsor

University of Georgia

Collaborators

Henry Ford Health System

1. Study Identification

Unique Protocol Identification Number

NCT02870725

Brief Title

CBT Depression Intervention for Co-Occurring Chronic Headache

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

November 2016 (Actual)

Primary Completion Date

June 22, 2017 (Actual)

Study Completion Date

July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Georgia

Collaborators

Henry Ford Health System

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Headaches Chronic, Migraine Disorders

Keywords

chronic headaches, migraines, depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group (Treatment As Usual)

Arm Type

No Intervention

Arm Description

Arm Title

CBT Individual Psychotherapy (Treatment)

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

CBT Individual Psychotherapy

Intervention Description

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 Measure Information:

Title

Mean change in "Beck Depression Inventory (BDI-2)"

Description

A 21-item likert scale developed to assess the intensity of depression while also monitoring changes over time.

Time Frame