One-Day Intervention for Depression and Impairment in Migraine Patients
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Migraine Headaches |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/24/2017 |
| Start Date: | September 2013 |
| End Date: | September 2017 |
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.
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.
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.
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.
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.
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