Depression, Migraine
Conditions
Brief summary
The researchers propose a two-arm pilot study of telephone and video delivered Mindfulness-based Cognitive Therapy (MBCT-T and MBCT-V) in people with migraine and depressive symptoms.
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 first phase is aimed at fidelity optimization of MBCT-T and MBCT-V 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
Mindfulness-based cognitive therapy (MBCT) comprised of 8 weekly classes delivered via telephone by a licensed clinical psychologist certified to teach MBCT, following treatment fidelity guidelines from NIH's Behavioral Change Consortium. The program involves a commitment of 1 hour per week for 8 weeks. During the sessions, subjects will learn cognitive and mindfulness skills to help manage and cope with depression. Each weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment.
BEHAVIORALMBCT-Video
Mindfulness-based cognitive therapy (MBCT) comprised of 8 weekly classes delivered via WebEx video-conferencing by a licensed clinical psychologist certified to teach MBCT, following treatment fidelity guidelines from NIH's Behavioral Change Consortium. The program involves a commitment of 1 hour per week for 8 weeks. During the sessions, subjects will learn cognitive and mindfulness skills to help manage and cope with depression. Each weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently meets ICHD-3 criteria for migraine using the Structured Diagnostic Interview for Headache * Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria * Score between 5-14 on the PHQ-9 * Age ≥ 18 * Ability to read and speak English * Capacity to consent
Exclusion criteria
* Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the Structure Diagnostic Interview for Headache * Changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake; changes in longer-term migraine prevention (onobotulinum toxin A, anti-calcitonin gene related peptide treatment) within 3 months of intake * Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the MBCT intervention, including but not limited to: active suicidal ideation; recent history of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities * Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy * Current meditation practice \>3x/week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Session Adherence Rate | Week 8 | Treatment Session Adherence is a measure of treatment feasibility and is defined as the number of scheduled treatments that were attended by the participants. This measure will be assessed through electronic monitoring of the attendance logs of each treatment session. A treatment arm will be considered feasible if participants attended/read 75% of sessions on average. |
| Average Client Satisfaction Questionnaire Score (CSQ-8) | Week 8 | The CSQ-8 is an 8-item generic standardized self-report tool to measure satisfaction with health and human services received by individuals and families. An overall score is calculated by summing the respondent's rating (item rating) score for each scale item. For the CSQ-8 version, scores range from 8 to 32, with higher values indicating higher satisfaction. A threshold score of greater than or equal to 24 is the cut-off for Acceptability. |
| Mean Score on MBCT-T/V Adherence & Competence Scales (MBCT-TACS) | Week 8 | The mindfulness-based cognitive therapy (MBCT)-TACS is an assessment of treatment fidelity in terms of adherence and competence. The scores per session are recorded between 0-3 and averaged to get the total score. The total range of score is 0-3; the higher the score, the higher the fidelity. |
| Homework Assignment Completion Rate | Week 8 | Defined as the proportion of assigned home-based practice that participants completed each week. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) Mindfulness-based cognitive therapy delivered by Telephone
MBCT-Telephone: Mindfulness-based cognitive therapy (MBCT) comprised of 8 weekly classes delivered via telephone by a licensed clinical psychologist certified to teach MBCT, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
The program involves a commitment of 1 hour per week for 8 weeks. During the sessions, subjects will learn cognitive and mindfulness skills to help manage and cope with depression. Each weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment. | 8 |
| MBCT-V (Mindfulness-Based Cognitive Therapy - Video) Mindfulness-based cognitive therapy delivered by Video
MBCT-Video: Mindfulness-based cognitive therapy (MBCT) comprised of 8 weekly classes delivered via WebEx video-conferencing by a licensed clinical psychologist certified to teach MBCT, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
The program involves a commitment of 1 hour per week for 8 weeks. During the sessions, subjects will learn cognitive and mindfulness skills to help manage and cope with depression. Each weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | Total | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 13 | 45 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 14 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 13 Participants | 7 Participants |
| Region of Enrollment United States | 8 participants | 16 participants | 8 participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 7 / 8 | 4 / 6 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Average Client Satisfaction Questionnaire Score (CSQ-8)
The CSQ-8 is an 8-item generic standardized self-report tool to measure satisfaction with health and human services received by individuals and families. An overall score is calculated by summing the respondent's rating (item rating) score for each scale item. For the CSQ-8 version, scores range from 8 to 32, with higher values indicating higher satisfaction. A threshold score of greater than or equal to 24 is the cut-off for Acceptability.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | Average Client Satisfaction Questionnaire Score (CSQ-8) | 29.3 score on a scale | Standard Deviation 3.2 |
| MBCT-V (Mindfulness-Based Cognitive Therapy - Video) | Average Client Satisfaction Questionnaire Score (CSQ-8) | 28.3 score on a scale | Standard Deviation 3.7 |
Primary
Homework Assignment Completion Rate
Defined as the proportion of assigned home-based practice that participants completed each week.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | Homework Assignment Completion Rate | 0.77 proportion of assignments completed | Standard Deviation 0.15 |
| MBCT-V (Mindfulness-Based Cognitive Therapy - Video) | Homework Assignment Completion Rate | 0.57 proportion of assignments completed | Standard Deviation 0.21 |
Primary
Mean Score on MBCT-T/V Adherence & Competence Scales (MBCT-TACS)
The mindfulness-based cognitive therapy (MBCT)-TACS is an assessment of treatment fidelity in terms of adherence and competence. The scores per session are recorded between 0-3 and averaged to get the total score. The total range of score is 0-3; the higher the score, the higher the fidelity.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | Mean Score on MBCT-T/V Adherence & Competence Scales (MBCT-TACS) | 2.9 score on a scale | Standard Deviation 0.3 |
| MBCT-V (Mindfulness-Based Cognitive Therapy - Video) | Mean Score on MBCT-T/V Adherence & Competence Scales (MBCT-TACS) | 2.8 score on a scale | Standard Deviation 0.4 |
Primary
Treatment Session Adherence Rate
Treatment Session Adherence is a measure of treatment feasibility and is defined as the number of scheduled treatments that were attended by the participants. This measure will be assessed through electronic monitoring of the attendance logs of each treatment session. A treatment arm will be considered feasible if participants attended/read 75% of sessions on average.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | Treatment Session Adherence Rate | 7.88 Number of sessions attended | Standard Deviation 0.35 |
| MBCT-V (Mindfulness-Based Cognitive Therapy - Video) | Treatment Session Adherence Rate | 8 Number of sessions attended | Standard Deviation 0 |