Trial Outcomes & Findings for TelemEdiciNe-bAsed Cognitive TherapY for Migraines (NCT NCT04613362)
NCT ID: NCT04613362
Last Updated: 2024-09-19
Results Overview
Daily self-reported migraine headaches using a VA text message protocol
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
3 Months after Baseline
Results posted on
2024-09-19
Participant Flow
Participants were recruited based on physician referral and recruitment cohort lists at 3 VA medical centers between April 2021 and April 2022. The first participant was enrolled on April 22, 2021 and the last participant was enrolled on April 29, 2022. All study procedures were conducted virtually and via telephone.
Of 80 enrolled participants, 57 met inclusion criteria after an initial screening phase and were randomized to treatment. Exclusions were as follows: less than 28 headache diary days completed (n=13), less than 8 headache days per month (n=7), and lost to follow-up (n=3).
Participant milestones
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Intervention Period
STARTED
|
30
|
27
|
|
Intervention Period
Received Intervention
|
27
|
17
|
|
Intervention Period
Did Not Receive Intervention
|
3
|
10
|
|
Intervention Period
COMPLETED
|
30
|
27
|
|
Intervention Period
NOT COMPLETED
|
0
|
0
|
|
3 Month Follow-up
STARTED
|
30
|
27
|
|
3 Month Follow-up
COMPLETED
|
29
|
25
|
|
3 Month Follow-up
NOT COMPLETED
|
1
|
2
|
|
6 Month Follow-up
STARTED
|
29
|
25
|
|
6 Month Follow-up
COMPLETED
|
29
|
24
|
|
6 Month Follow-up
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
3 Month Follow-up
Lost to Follow-up
|
1
|
2
|
|
6 Month Follow-up
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
TelemEdiciNe-bAsed Cognitive TherapY for Migraines
Baseline characteristics by cohort
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=30 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=27 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 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
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 Months after BaselineDaily self-reported migraine headaches using a VA text message protocol
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=30 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=27 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Number of Headache Days at 3 Months
Baseline
|
18.17 headache days
Standard Deviation 7.82
|
19.19 headache days
Standard Deviation 8.54
|
|
Number of Headache Days at 3 Months
3 months
|
16.47 headache days
Standard Deviation 10.17
|
18.26 headache days
Standard Deviation 11.05
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Summary Costs
Costs associated with program implementation
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=30 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=27 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Budget Impact Analysis - Cost of Training (Implementation)
|
12020.99 dollars
|
271.57 dollars
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Summary Time (hours of training)
Time associated with program implementation
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=30 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=27 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Budget Impact Analysis - Time
|
201.1 hours
|
4.0 hours
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Summary Costs
Costs associated with intervention per Veteran
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=30 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=27 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Budget Impact Analysis - Cost Per Veteran
|
194.46 dollars
Standard Deviation 107.47
|
113.52 dollars
Standard Deviation 210.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months, 6 monthsPopulation: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
The MSQ is a 14-item measure of headache-related quality of life. Higher scores indicate a higher quality of life. Unscaled scores range from 0 to 70.
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=24 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=24 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Migraine-Specific Quality of Life Questionnaire (MSQ)
3 months
|
48.39 score on a scale
Standard Deviation 23.07
|
57.06 score on a scale
Standard Deviation 19.36
|
|
Migraine-Specific Quality of Life Questionnaire (MSQ)
6 months
|
48.79 score on a scale
Standard Deviation 24.29
|
53.32 score on a scale
Standard Deviation 16.72
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 and 6 monthsPopulation: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
The MIDAS is a 5-item, self-report measure of disability related to headache based on number of missed or significantly limited activity days due to headache in school or paid work, household work, and family, social, or leisure activities. Responses are categorized as follows: little or no disability (0-5), mild disability (6-10), moderate disability (11-20), and severe disability (21+). Scale has a range from 0 to 270, with a higher score indicating a worse outcome.
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=23 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=22 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Migraine Disability Assessment (MIDAS)
3 months
|
83.09 score on a scale
Standard Deviation 68.72
|
64.94 score on a scale
Standard Deviation 47.59
|
|
Migraine Disability Assessment (MIDAS)
6 months
|
63.17 score on a scale
Standard Deviation 61.88
|
68.68 score on a scale
Standard Deviation 61.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 and 6 monthsPopulation: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
The HPCS is a modified version of the validated Pain Catastrophizing Scale (substitutes "headache" for "pain" in the questions). The HPCS is a 13-item measure used to assess catastrophic thinking related to headache. Item responses range from 0 to 4 (0 = not at all, 4 = all the time). Total scores range from 0 to 52, with higher scores indicating higher levels of catastrophizing.
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=23 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=22 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Headache-specific Pain Catastrophizing Scale (HPCS)
3 months
|
26.69 score on a scale
Standard Deviation 17.05
|
20.88 score on a scale
Standard Deviation 9.69
|
|
Headache-specific Pain Catastrophizing Scale (HPCS)
6 months
|
23.55 score on a scale
Standard Deviation 18.57
|
23.84 score on a scale
Standard Deviation 11.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 and 6 monthsPopulation: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
The HMSE is a 25-item measure used to assess a participant's perception of their ability to take actions to prevent and manage their headaches and headache-related disability. Item responses range from 1 to 7 (1 = strongly disagree, 7 = strongly agree). Total scores range from 25 to 175 with higher scores indicating higher levels of headache management self-efficacy.
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=24 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=22 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Headache Management Self-Efficacy Scale (HMSE)
3 months
|
101.09 score on a scale
Standard Deviation 26.16
|
113.39 score on a scale
Standard Deviation 19.37
|
|
Headache Management Self-Efficacy Scale (HMSE)
6 months
|
103.97 score on a scale
Standard Deviation 31.04
|
111.00 score on a scale
Standard Deviation 23.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: This measure was only collected at baseline. The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
The PCL is a validated 20-item, self-report measure of PTSD symptoms. Items are rated from 0 to 4 (0 = not at all, 4 = extremely). Total scores range from 0-80. Higher scores indicate higher post-traumatic stress symptoms.
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=24 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=24 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
PCL-5 (Post-Traumatic Stress Disorder Checklist)
|
33.29 score on a scale
Standard Deviation 17.62
|
29.25 score on a scale
Standard Deviation 20.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 and 6 monthsPopulation: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
The PHQ-9 is a reliable and well-validated self-report measure of depressive symptom severity and suicide risk based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. Items are rated from 0 to 3 (0 = not at all, 3 = nearly every day). Total scores range from 0 to 27. Totals are categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=22 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=23 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Patient Health Questionnaire - PHQ-9
3 months
|
9.27 score on a scale
Standard Deviation 6.28
|
10.83 score on a scale
Standard Deviation 5.11
|
|
Patient Health Questionnaire - PHQ-9
6 months
|
8.61 score on a scale
Standard Deviation 5.46
|
7.88 score on a scale
Standard Deviation 4.88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 and 6 monthsPopulation: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
The GAD-7 is a reliable and validated 7-item, self-report measure of anxiety. Items are rated from 0 to 3 (0 = not at all, 3 = nearly every day). Total scores range from 0 to 21 and are categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxious symptoms.
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=23 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=21 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Generalized Anxiety Disorder (GAD-7)
3 months
|
9.04 score on a scale
Standard Deviation 6.43
|
6.78 score on a scale
Standard Deviation 4.17
|
|
Generalized Anxiety Disorder (GAD-7)
6 months
|
8.30 score on a scale
Standard Deviation 6.28
|
8.90 score on a scale
Standard Deviation 4.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 and 6 monthsPopulation: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
The VR-12 is a 12-item measure used to assess health related quality of life and to produce physical and mental health component scores. The 12 items are summed into a physical component score (PCS) and a mental component score (MCS). Both the PCS and MCS scores are transformed to a scale with a range of 1-100. A higher score indicates better health.
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=23 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=22 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Veterans RAND 12 (VR-12)
Physical Component Scale - 3 months
|
41.84 score on a scale
Standard Deviation 5.14
|
41.94 score on a scale
Standard Deviation 4.15
|
|
Veterans RAND 12 (VR-12)
Physical Component Scale - 6 months
|
39.93 score on a scale
Standard Deviation 5.90
|
40.20 score on a scale
Standard Deviation 4.85
|
|
Veterans RAND 12 (VR-12)
Mental Component Scale - 3 months
|
34.56 score on a scale
Standard Deviation 10.15
|
34.81 score on a scale
Standard Deviation 5.95
|
|
Veterans RAND 12 (VR-12)
Mental Component Scale - 6 months
|
35.02 score on a scale
Standard Deviation 7.78
|
38.02 score on a scale
Standard Deviation 6.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 and 6 monthsPopulation: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
The ISI is a 7-item measure of the participant's perceptions of their insomnia, such as severity of sleep-onset and sleep maintenance difficulties. Items are rated from 0 to 4 (0 = not at all, 4 = very much). Total scores range from 0 to 28. Totals are categorized as follows: no clinically significant insomnia (0-7), subthreshold insomnia (8-14), clinical insomnia (moderately severe) (15-21), clinical insomnia (severe) (22-28).
Outcome measures
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=23 Participants
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=21 Participants
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Insomnia Severity Index (ISI)
3 months
|
16.35 score on a scale
Standard Deviation 7.44
|
13.28 score on a scale
Standard Deviation 6.45
|
|
Insomnia Severity Index (ISI)
6 months
|
16.91 score on a scale
Standard Deviation 8.74
|
14.86 score on a scale
Standard Deviation 5.48
|
Adverse Events
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Behavioral Usual Care
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=30 participants at risk
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=27 participants at risk
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Gastrointestinal disorders
colitis
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Gastrointestinal disorders
stomach pain
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Gastrointestinal disorders
bowel obstruction
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Infections and infestations
flu
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
Other adverse events
| Measure |
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
n=30 participants at risk
Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine: Clinical health psychology therapy delivered via telehealth
|
Behavioral Usual Care
n=27 participants at risk
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.
Behavioral Usual Care: Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
|
|---|---|---|
|
Immune system disorders
allergic reaction
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Musculoskeletal and connective tissue disorders
arm/leg pain
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Cardiac disorders
chest pain
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Gastrointestinal disorders
GERD
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Infections and infestations
COVID
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
11.1%
3/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
General disorders
dehydration
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Psychiatric disorders
depressive symptoms
|
6.7%
2/30 • Number of events 3 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
7.4%
2/27 • Number of events 2 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Gastrointestinal disorders
diarrhea
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Injury, poisoning and procedural complications
fall
|
6.7%
2/30 • Number of events 3 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Infections and infestations
fever
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Infections and infestations
flu
|
6.7%
2/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Metabolism and nutrition disorders
foot pain
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Gastrointestinal disorders
hernia
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Immune system disorders
hives
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
General disorders
insomnia
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Cardiac disorders
irregular heartbeat
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
General disorders
migraine
|
3.3%
1/30 • Number of events 2 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Musculoskeletal and connective tissue disorders
pain symptoms
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
7.4%
2/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Skin and subcutaneous tissue disorders
plantar wart
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Psychiatric disorders
PTSD
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Infections and infestations
sinus infection
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Infections and infestations
stomach virus
|
0.00%
0/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
3.7%
1/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
|
Injury, poisoning and procedural complications
superficial burn
|
3.3%
1/30 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
0.00%
0/27 • Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.
Adverse event collection was performed by participant self-reporting to study personnel.
|
Additional Information
Dr. Teresa Damush
Richard L. Roudebush VA Medical Center
Phone: 317-988-4277
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place