Trial Outcomes & Findings for Treatment for Migraine and Mood (Team-M) (NCT NCT04992494)
NCT ID: NCT04992494
Last Updated: 2023-07-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Week 8
Results posted on
2023-07-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment for Migraine and Mood (Team-M)
Baseline characteristics by cohort
| Measure |
MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone)
n=8 Participants
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.
|
MBCT-V (Mindfulness-Based Cognitive Therapy - Video)
n=8 Participants
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.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 13 • n=5 Participants
|
44 years
STANDARD_DEVIATION 14 • n=7 Participants
|
45 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Treatment 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.
Outcome measures
| Measure |
MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone)
n=8 Participants
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.
|
MBCT-V (Mindfulness-Based Cognitive Therapy - Video)
n=8 Participants
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.
|
|---|---|---|
|
Treatment Session Adherence Rate
|
7.88 Number of sessions attended
Standard Deviation 0.35
|
8 Number of sessions attended
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 8The 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."
Outcome measures
| Measure |
MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone)
n=8 Participants
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.
|
MBCT-V (Mindfulness-Based Cognitive Therapy - Video)
n=7 Participants
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.
|
|---|---|---|
|
Average Client Satisfaction Questionnaire Score (CSQ-8)
|
29.3 score on a scale
Standard Deviation 3.2
|
28.3 score on a scale
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: Week 8The 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.
Outcome measures
| Measure |
MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone)
n=8 Participants
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.
|
MBCT-V (Mindfulness-Based Cognitive Therapy - Video)
n=8 Participants
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.
|
|---|---|---|
|
Mean Score on MBCT-T/V Adherence & Competence Scales (MBCT-TACS)
|
2.9 score on a scale
Standard Deviation 0.3
|
2.8 score on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Week 8Defined as the proportion of assigned home-based practice that participants completed each week.
Outcome measures
| Measure |
MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone)
n=6 Participants
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.
|
MBCT-V (Mindfulness-Based Cognitive Therapy - Video)
n=8 Participants
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.
|
|---|---|---|
|
Homework Assignment Completion Rate
|
0.77 proportion of assignments completed
Standard Deviation 0.15
|
0.57 proportion of assignments completed
Standard Deviation 0.21
|
Adverse Events
MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MBCT-V (Mindfulness-Based Cognitive Therapy - Video)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone)
n=8 participants at risk
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.
|
MBCT-V (Mindfulness-Based Cognitive Therapy - Video)
n=6 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Increased severity of migraine
|
12.5%
1/8 • 16 weeks
Adverse events were systematically assessed using weekly questionnaires during the study intervention. Serious adverse events and all-cause mortality were not monitored/assessed.
|
0.00%
0/6 • 16 weeks
Adverse events were systematically assessed using weekly questionnaires during the study intervention. Serious adverse events and all-cause mortality were not monitored/assessed.
|
|
General disorders
Flashback
|
25.0%
2/8 • 16 weeks
Adverse events were systematically assessed using weekly questionnaires during the study intervention. Serious adverse events and all-cause mortality were not monitored/assessed.
|
16.7%
1/6 • 16 weeks
Adverse events were systematically assessed using weekly questionnaires during the study intervention. Serious adverse events and all-cause mortality were not monitored/assessed.
|
|
Infections and infestations
COVID infection
|
25.0%
2/8 • 16 weeks
Adverse events were systematically assessed using weekly questionnaires during the study intervention. Serious adverse events and all-cause mortality were not monitored/assessed.
|
33.3%
2/6 • 16 weeks
Adverse events were systematically assessed using weekly questionnaires during the study intervention. Serious adverse events and all-cause mortality were not monitored/assessed.
|
|
Endocrine disorders
Worsening hyperthyroidism
|
12.5%
1/8 • 16 weeks
Adverse events were systematically assessed using weekly questionnaires during the study intervention. Serious adverse events and all-cause mortality were not monitored/assessed.
|
0.00%
0/6 • 16 weeks
Adverse events were systematically assessed using weekly questionnaires during the study intervention. Serious adverse events and all-cause mortality were not monitored/assessed.
|
|
General disorders
Worsening mood
|
12.5%
1/8 • 16 weeks
Adverse events were systematically assessed using weekly questionnaires during the study intervention. Serious adverse events and all-cause mortality were not monitored/assessed.
|
16.7%
1/6 • 16 weeks
Adverse events were systematically assessed using weekly questionnaires during the study intervention. Serious adverse events and all-cause mortality were not monitored/assessed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place