Depressive Symptoms, Migraine
Conditions
Keywords
mindfulness, mindfulness-based cognitive therapy
Brief summary
The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC).
Detailed description
This study aims to set the stage for a future definitive large-scale Phase III trial in patients with migraine and depressive symptoms. This pilot is aimed at evaluating the feasibility and acceptability of the Telephone and Video MBCT and EUC in people with migraine (defined by the International Classification of Headache Disorders - 3) and depressive symptoms (defined by empirical cut-offs on the Patient Health Questionnaire - 9).
Interventions
BEHAVIORALMBCT-Telephone
Classes follow MBCT protocol delivered via telephone by a master's level or higher mental health provider under the supervision of a licensed clinical psychologist, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
BEHAVIORALMBCT-Video
Classes follow MBCT protocol delivered via video by a master's level or higher mental health provider under the supervision of a licensed clinical psychologist, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
BEHAVIORALEnhanced Usual Care (EUC)
Weekly online modules follow migraine and behavior principles delivered via web portal developed by a team of licensed clinical psychologists, neurologists, and mental health providers.
Sponsors
Amanda Shallcross
Yeshiva University
Wake Forest University Health Sciences
The Cleveland Clinic
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently meets ICHD-3 criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module * Self-reported 4-20 headache days per month * Score between 5-19 on the PHQ-8 * Age ≥ 18 * Ability to read and speak English * Capacity to consent * ≥1 year of migraine
Exclusion criteria
* Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post- traumatic headache) on the American Migraine Prevalence and Prevention Diagnostic Module * Changes in anti-depressant medication within 6 weeks of intake * Starting or changing a migraine preventive treatment (i.e., oral medication, injection, preventive medicine, neuromodulatory device) within 12 weeks of intake * Changes in acute migraine treatment started within 4 weeks of enrollment * Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the MBCT-T intervention, including but not limited to: active suicidal ideation; current or recent history (in the last six months) of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities;, discomfort participating in a group-based intervention, drug use * Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy * Current daily meditation practice * Unwilling to maintain stable current acute or preventive medication dosages for study duration * Any condition that would prevent being a suitable candidate for the group intervention * Medication overuse headache with migraine treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treatment Session Adherence | Week 8 | Treatment Session Adherence is a measure of treatment feasibility. This measure will be assessed through electronic monitoring of the attendance logs of each treatment session. The number of treatment sessions attended will be recorded. A treatment arm will be considered feasible if participants attended/read 75% of sessions on average. |
| Client Satisfaction Questionnaire - 8 (CSQ-8) | Week 8 | The CSQ-8 assesses treatment acceptability. The CSQ-8 is an 8-item self-report measure designed to assess satisfaction with mental health services. Response options are coded on a 4-point scale and summed to produce a total score ranging from 8-32. The measure has consistently demonstrated excellent reliability and validity, and is commonly used in behavioral treatment trials. For the purposes of this study, a CSQ-8 score \> 24 is considered acceptable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Headache Disability Inventory (HDI) | Month 0 to Month 3 | The HDI is a 25-item self-report survey which assesses perceived emotional and functional impact of headache on daily activities. Sample items include, "Because of my headaches I feel restricted in performing my routine daily activities," with response options of "Yes," "Sometimes," and "No." Total scores range from 0-100, with higher scores indicating higher disability. The slope of change between Month 0 and 3 represents a secondary outcome designed to evaluate clinical signal in this pilot study. |
| Change in Migraine-Specific Quality of Life Questionnaire v 2.1 (MSQ) | Month 0 to Month 3 | The MSQ is a 14-item self-report survey which assesses quality of life over the past 4 weeks in people with migraine. Items comprise three subscales: Role Restriction, Role Prevention, and Emotion Function. Each item is scored on a Likert-type scale from 1 ("None of the time") to 6 ("All of the time"). Total scores range from 14-84. The slope of change between Month 0 and 3 represents a secondary outcome designed to evaluate clinical signal in this pilot study. |
| Change in Quick Inventory of Depressive Symptomatology - Self-Report 16 (QIDS-SR16) | Month 0 to Month 3 | The QIDS-SR16 measures depressive symptom domains during the prior 7 days. Each item is scored on a scale from 0 to 3 points. Total scores range from 0 to 27. Score cutoffs are: 1-5 for no depression, 6-10 for mild depression, 11-15 for moderate depression, 16-20 for severe depression, and 17-27 for very severe depression. The slope of change between Month 0 and 3 represents a secondary outcome designed to evaluate clinical signal in this pilot study. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElizabeth K Seng, Ph.D.
Albert Einstein College of Medicine and Yeshiva University
PRINCIPAL_INVESTIGATORAmanda J Shallcross, M.P.H., N.D.
The Cleveland Clinic
Outcome results
None listed