A Phase 2 interventional study of MBCT-Telephone and MBCT-Video in Migraine and Depression, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by NYU Langone Health · Phase 2, Interventional, and Treatment
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.
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).
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 27 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mindfulness-based cognitive therapy delivered by Telephone
Behavioral: MBCT-Telephone
Mindfulness-based cognitive therapy delivered by Video
Behavioral: MBCT-Video
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.
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.
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
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
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
Homework Assignment Completion Rate
Defined as the proportion of assigned home-based practice that participants completed each week.
Time frame: Week 8
| Milestone | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
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.
| Number of sessions attended | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) |
|---|---|---|
| Treatment Session Adherence Rate | 7.88 ± 0.35 | 8 ± 0 |
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."
| score on a scale | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) |
|---|---|---|
| Average Client Satisfaction Questionnaire Score (CSQ-8) | 29.3 ± 3.2 | 28.3 ± 3.7 |
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.
| score on a scale | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) |
|---|---|---|
| Mean Score on MBCT-T/V Adherence & Competence Scales (MBCT-TACS) | 2.9 ± 0.3 | 2.8 ± 0.4 |
Defined as the proportion of assigned home-based practice that participants completed each week.
| proportion of assignments completed | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) |
|---|---|---|
| Homework Assignment Completion Rate | 0.77 ± 0.15 | 0.57 ± 0.21 |
Collected over 16 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | — | — | 7/8 (87.5%) |
| MBCT-V (Mindfulness-Based Cognitive Therapy - Video) | — | — | 4/6 (66.7%) |
| Event | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) |
|---|---|---|
| COVID infectionInfections and infestations | 2/8 | 2/6 |
| FlashbackGeneral disorders | 2/8 | 1/6 |
| Worsening moodGeneral disorders | 1/8 | 1/6 |
| Increased severity of migraineNervous system disorders | 1/8 | 0/6 |
| Worsening hyperthyroidismEndocrine disorders | 1/8 | 0/6 |
| Age, Continuous(years) | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) | Total |
|---|---|---|---|
| Mean | 46 ± 13 | 44 ± 14 | 45 ± 13 |
| Sex: Female, Male(Participants) | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 6 | 8 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 6 | 7 | 13 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) | Total |
|---|---|---|---|
| United States | 8 | 8 | 16 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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