MigraineACTNCT02108678
One-Day Intervention for Depression and Impairment in Migraine Patients
A study testing ACT-ME and Migraine Education Only in people with Migraine and Depression, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Depression
- What is being tested?
- ACT-ME and Migraine Education Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bipolar, psychotic, or current substance use disorders
- History of brain injury
- Imminent suicidality.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Carver College of Medicine Department of Psychiatry
Iowa City, Iowa, 52242
About this study
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.
Read the 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.
- Conditions
- Migraine, Depression
- Being tested
- ACT-ME, Migraine Education Only
- Keywords
- Acceptance and Commitment Therapy (ACT), Depression, Illness Management, Behavioral Treatment, Impairment
- Medical subject headings
- Migraine Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-MEBehavioural
Also called Acceptance and Commitment Training Plus Migraine Education
1 hour discussion about migraine education (ME) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). Migraine education covers topics including migraine symptoms, triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations.
Migraine Education OnlyBehavioural
Also called Illness Management
6 hour discussion of migraine education only (MEO). This will involve educating participants about migraine, its natural course, its prodromal symptoms and triggers for symptom worsening, risk for migraine chronification, how to use abortive migraine medications, medication overuse headache, medical and psychological treatments of migraine, migraine comorbidity, and menstrual migraine.
| Study group | Role | What they receive |
|---|---|---|
| ACT-ME | Experimental | ACT-ME is designed to reduce behavioral avoidance and to enhance acceptance-based coping. It includes: 1) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 2) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations; and 3) Migraine education whereby each of the educational topics listed below will be covered without detailed discussion of the topics. Receives: Behavioral: ACT-ME |
| Migraine Education Only | Experimental | The MEO workshop will last six hours and involve educating participants about migraine, its natural course, its prodromal symptoms and triggers for symptom worsening, risk for migraine chronification, how to use abortive migraine medications, medication overuse headache, medical and psychological treatments of migraine, migraine comorbidity, and menstrual migraine. The group leaders will present one educational topic at a time and the participants will discuss and reflect about issues and experiences related to the topic. If necessary, the group leaders will raise specific discussion questions to facilitate group dialogue and participant involvement. However, information on coping practices will be omitted. Receives: Behavioral: Migraine Education Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRSD
The HRSD is a structured clinical interview for depression severity. Change from baseline measured at 2, 6, 12, and 24 weeks post workshop.
Measured: 24 weeks
SCID-IV
Semi-structured clinical interview for depression. Change from baseline measured at 12 and 24 weeks post workshop.
Measured: 24 weeks
Secondary outcomes (3)
WHO-DAS-II
This is a self-report questionnaire that measures difficulties due to physical and mental health conditions. Measure change from baseline at 12 and 24 weeks post-workshop.
Measured: 24 weeks
WHO-QOL
The WHO-QOL is a self-report measure that assesses four domains of quality of life: physical health, psychological well-being, social relationships, and environment. Measure change from baseline at 12 and 24 weeks post workshop.
Measured: 24 weeks
HDI
The HDI is a self-report measure that assesses the burden of headaches through perceived impact of headaches on functioning. Measure changes from baseline at 12 and 24 weeks post workshop.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilian Dindo, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108678
- Sponsor's protocol ID
- 201301712
- Acronym
- ACT
- Status last verified
- Dec 2017
- First submitted
- 28 Mar 2014
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dindo LN, Recober A, Calarge CA, Zimmerman BM, Weinrib A, Marchman JN, Turvey C. One-Day Acceptance and Commitment Therapy Compared to Support for Depressed Migraine Patients: a Randomized Clinical Trial. Neurotherapeutics. 2020 Apr;17(2):743-753. doi: 10.1007/s13311-019-00818-0.
PubMed 31863406
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Day Intervention for Depression and Impairment in Migraine Patients
- ClinicalTrials.gov ID
- NCT02108678
- Acronym / sponsor ID
- ACT / 201301712
- Conditions
- Migraine, Depression
- Keywords
- Acceptance and Commitment Therapy (ACT), Depression, Illness Management, Behavioral Treatment, Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-ME | Experimental | Behavioral: ACT-MEACT-ME is designed to reduce behavioral avoidance and to enhance acceptance-based coping. It includes: 1) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 2) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations; and 3) Migraine education whereby each of the educational topics listed below will be covered without detailed discussion of the topics. |
| Migraine Education Only | Experimental | Behavioral: Migraine Education OnlyThe MEO workshop will last six hours and involve educating participants about migraine, its natural course, its prodromal symptoms and triggers for symptom worsening, risk for migraine chronification, how to use abortive migraine medications, medication overuse headache, medical and psychological treatments of migraine, migraine comorbidity, and menstrual migraine. The group leaders will present one educational topic at a time and the participants will discuss and reflect about issues and experiences related to the topic. If necessary, the group leaders will raise specific discussion questions to facilitate group dialogue and participant involvement. However, information on coping practices will be omitted. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Bipolar, psychotic, or current substance use disorders
- History of brain injury
- Imminent suicidality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-MEAlso: Acceptance and Commitment Training Plus Migraine Education1 hour discussion about migraine education (ME) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). Migraine education covers topics including migraine symptoms, triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations. | Behavioural | ACT-ME |
| Migraine Education OnlyAlso: Illness Management6 hour discussion of migraine education only (MEO). This will involve educating participants about migraine, its natural course, its prodromal symptoms and triggers for symptom worsening, risk for migraine chronification, how to use abortive migraine medications, medication overuse headache, medical and psychological treatments of migraine, migraine comorbidity, and menstrual migraine. | Behavioural | Migraine Education Only |
Primary outcome
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.
3 secondary outcomes
WHO-DAS-II
Time frame: 24 weeks
WHO-QOL
Time frame: 24 weeks
HDI
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Derived from this study: PubMed 31863406Dindo LN, Recober A, Calarge CA, Zimmerman BM, Weinrib A, Marchman JN, Turvey C. One-Day Acceptance and Commitment Therapy Compared to Support for Depressed Migraine Patients: a Randomized Clinical Trial. Neurotherapeutics. 2020 Apr;17(2):743-753. doi: 10.1007/s13311-019-00818-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-ME and Migraine Education Only in people with Migraine and Depression, run by Baylor College of Medicine at 1 site 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 3 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 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
HRSD (time frame: 24 weeks). 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 NCT02108678, which also lists 1 linked publication.
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 22 Dec 2017.