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DepressionNCT02870725

CBT Depression Intervention for Co-Occurring Chronic Headache

A study testing CBT Individual Psychotherapy in people with Depression and Headaches Chronic, run by University of Georgia at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Depression, Headaches Chronic, Migraine Disorders
What is being tested?
CBT Individual Psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesUnited States
Study dates
Nov 2016to 1 Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Georgia

    Athens, Michigan, 30601

  • Henry Ford Hospital

    Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
CBT Individual Psychotherapy
Keywords
chronic headaches, migraines, depression
Medical subject headings
Depression, Headache Disorders, Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT Individual PsychotherapyBehavioural

    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.

Study groups in NCT02870725
Study groupRoleWhat they receive
Control Group (Treatment As Usual)No interventionIndividuals 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)ExperimentalBehavioral 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.
Receives: Behavioral: CBT Individual Psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up

  2. 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.

    Measured: Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up

Secondary outcomes (3)

  1. 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

    Measured: Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up

  2. 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.

    Measured: Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up

  3. 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.

    Measured: Initial 4-week change from pre-intervention to post-intervention & at 4-week post-intervention follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion22 Jun 2017
  4. Study completion1 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02870725
Sponsor's protocol ID
002322
Status last verified
Jul 2017
First submitted
2 Feb 2016
Last updated
6 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No: 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.

Publications

  • Baskin SM, Lipchik GL, Smitherman TA. Mood and anxiety disorders in chronic headache. Headache. 2006 Oct;46 Suppl 3:S76-87. doi: 10.1111/j.1526-4610.2006.00559.x.

    PubMed 17034402

  • Weeks RE. Application of behavioral therapies in adult and adolescent patients with chronic migraine. Neurol Sci. 2013 May;34 Suppl 1:S11-7. doi: 10.1007/s10072-013-1360-6.

    PubMed 23695037

  • 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.

  • Saper JR. Pearls from an inpatient headache unit. Headache. 2008 Jun;48(6):820-7. doi: 10.1111/j.1526-4610.2008.01141.x.

    PubMed 18549359

  • Shapiro R, Goadsby P. The long drought: the dearth of public funding for headache research. Cephalalgia. 2007 Sep;27(9):991-4. doi: 10.1111/j.1468-2982.2007.01396.x. No abstract available.

    PubMed 17727471

  • 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.

  • Breslau N, Lipton RB, Stewart WF, Schultz LR, Welch KM. Comorbidity of migraine and depression: investigating potential etiology and prognosis. Neurology. 2003 Apr 22;60(8):1308-12. doi: 10.1212/01.wnl.0000058907.41080.54.

    PubMed 12707434

  • Castien RF, van der Windt DA, Dekker J, Mutsaers B, Grooten A. Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: design of a randomised clinical trial. BMC Musculoskelet Disord. 2009 Feb 12;10:21. doi: 10.1186/1471-2474-10-21.

    PubMed 19216763

  • Frediani F, Villani V. Migraine and depression. Neurol Sci. 2007 May;28 Suppl 2:S161-5. doi: 10.1007/s10072-007-0771-7.

    PubMed 17508165

  • Hamelsky SW, Lipton RB. Psychiatric comorbidity of migraine. Headache. 2006 Oct;46(9):1327-33. doi: 10.1111/j.1526-4610.2006.00576.x.

    PubMed 17040330

  • Sammons M. Treatment of head pain with psychotropics. Professional Psychology: Research and Practice, 36(6): 611-614, 2005.

  • Shulman, R. (2013, May 17). Psychiatric Aspects of Headache, Pain and Depression [Webinar]. In National Headache Foundation Webinar Series. Retrieved January 30, 2015 from https://www.youtube.com/watch?v=4n3BTs6-fFU&list=PL6bpjkbYtk-MBnNjRF7pAxzBJI52_XdPd.

  • Smitherman TA, McDermott MJ, Buchanan EM. Negative impact of episodic migraine on a university population: quality of life, functional impairment, and comorbid psychiatric symptoms. Headache. 2011 Apr;51(4):581-9. doi: 10.1111/j.1526-4610.2011.01857.x.

    PubMed 21457242

Questions about this trial

What is this clinical trial studying?

A study testing CBT Individual Psychotherapy in people with Depression and Headaches Chronic, run by University of Georgia at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02870725, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017; AzTrials last refreshed its copy on 27 Oct 2026.

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