Skip to main content
Clinical Trials/NCT02108678
NCT02108678
Completed
Not Applicable

One-Day Intervention for Depression and Impairment in Migraine Patients

Baylor College of Medicine1 site in 1 country104 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Migraine
Sponsor
Baylor College of Medicine
Enrollment
104
Locations
1
Primary Endpoint
HRSD
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this research study is to examine whether a one-day group workshop, integrating principles from Acceptance and Commitment Therapy and Migraine Education, will result in greater improvements in depressive symptoms and functioning impairment in patients with comorbid migraine and depression than a similar one-day group workshop with Migraine Education only.

Detailed Description

Adults with comorbid depression and migraine will be randomized to a 1-day (6-hour) workshop of Acceptance and Commitment Training + Migraine Education (ACT-ME) or Migraine Education only (MEO). The intervention delivered to both study arms will be identical except for the addition of the ACT component delivered in the ACT-ME condition, thereby allowing an estimate of the specific additive effect of the psychotherapy. Measures of acceptance and behavioral avoidance, theoretically important mechanisms of change, will be used to test intervention components by examining whether these processes are uniquely affected by the ACT-ME intervention and whether they account for observed treatment effects. The central hypothesis is that the ACT-ME treatment will lead to significantly greater reduction in depression (HRSD) and disability (WHO-DAS, WHOQOL, and HDI) at follow-up compared to the MEO treatment. ACT-ME participants also are expected to demonstrate reductions in behavioral avoidance and enhanced acceptance, which mediate treatment effects. Treatment gains are expected to be maintained through the 6-month follow-up. Aim 1: To examine the efficacy of a 1-day ACT-ME intervention compared to MEO for treating depression in patients with comorbid depression and migraine. Hypothesis 1: At 3- and 6-month follow-up, ACT-ME will be more efficacious than MEO as assessed by: 1) a significantly greater decline on the Hamilton Rating Scale for Depression (HRSD) total score; 2) a significantly higher proportion of participants showing 50% or greater decline on the HRSD; and 3) a significantly higher proportion of participants no longer meeting depression criteria on SCID-IV. Aim 2: To examine the efficacy of a 1-day ACT-ME intervention compared to MEO on functioning in patients with comorbid depression and migraine. Hypothesis 2: At 3- and 6-month follow-up, compared to the MEO group, participants in the ACT-ME group will exhibit significantly greater improvement in functioning (measured by World Health Organization Disability Assessment Schedule-Total Score; WHO-DAS) and quality of life (measured by World Health Organization Quality of Life Total; WHO-QOL), and greater decline in headache-related disability (measured by Headache Disability Inventory; HDI). Aim 3: To determine whether changes in acceptance-based coping and behavioral avoidance will mediate the changes in depressive symptoms and disability. Hypothesis 3: Increases in acceptance-based coping and reductions in behavioral avoidance will mediate relations between treatment group and 1) decline in depressive symptoms as measured by the HRSD and 2) disability, as measured by the WHO-DAS and HDI. Acceptance and Behavioral Avoidance will be measured using the Acceptance and Action Questionnaire and Chronic Pain Acceptance Questionnaire.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
September 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lilian Dindo

Professor

Baylor College of Medicine

Eligibility Criteria

Inclusion Criteria

  • Ages 18-65
  • Current major depressive episode on the SCID-IV (46)
  • Score of ≥ 17 on the HRSD (47)
  • Confirmation of diagnosis of migraine from medical record
  • 4-12 migraines in the previous month

Exclusion Criteria

  • Bipolar, psychotic, or current substance use disorders
  • History of brain injury
  • Imminent suicidality.

Outcomes

Primary Outcomes

HRSD

Time Frame: 24 weeks

The HRSD is a structured clinical interview for depression severity. Change from baseline measured at 2, 6, 12, and 24 weeks post workshop.

SCID-IV

Time Frame: 24 weeks

Semi-structured clinical interview for depression. Change from baseline measured at 12 and 24 weeks post workshop.

Secondary Outcomes

  • WHO-DAS-II(24 weeks)
  • WHO-QOL(24 weeks)
  • HDI(24 weeks)

Study Sites (1)

Loading locations...

Similar Trials