CBT Depression Intervention for Co-Occurring Chronic Headache

University of Georgia (UGA)

Status: Completed

Conditions: Migraine Disorders; Headaches Chronic; Depression

Treatments: Behavioral: CBT Individual Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02870725

002322

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Control Group (Treatment As Usual)

No Intervention group

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.

CBT Individual Psychotherapy (Treatment)

Experimental group

Description:

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.

Treatment:

Behavioral: CBT Individual Psychotherapy