Migraine Headache
Conditions
Keywords
Implementation Science, Telehealth, Cognitive Behavioral Therapy
Brief summary
The goal of this pilot study is to evaluate a bundle of implementation strategies at three Veteran Affairs Medical Centers (VAMCs) to facilitate the referral and adoption of a telehealth based, cognitive behavioral therapy program delivered by Health Psychologists for Veterans with chronic migraine to inform a future fully-powered hybrid type 2 effectiveness-implementation design. Veteran patients will be randomized to either the telehealth delivered CBT or usual care. Headache symptoms and severity will be reported using a VA text messaging application.
Detailed description
With VHA's infrastructure dedicated to efficient telehealth delivery into patient homes, the delivery of a behavioral intervention for chronic migraine, CM, via the telehealth platform is primed to address barriers of in-person care delivery and holds considerable promise to reach and improve Veteran headache-related quality of life. Therefore, the goal is to evaluate an adapted bundle of EB implementation strategies to increase adoption of a Telemedicine-based Cognitive Behavioral Therapy (CBT) program (TENACITY) for CM in 2 VA HCoEs (VA Connecticut Healthcare System \[VACHS\], a large, multi-disciplinary HCoE, and Birmingham VA Medical Center \[BVAMC\], a smaller VA Headache Consortium Center. The HCoEs are charged with improving headache care throughout the VA, not just within an individual VAMC. As part of this study, a non-HCoE will also participate, providing an opportunity for the TENACITY study to extend this virtual specialty headache care to Veterans without headache specialty care. Dallas VA Medical Center, also known as the North Texas Health Care System \[NTHCS\] will participate as a third site. The investigators will determine whether TENACITY can be efficiently delivered through the vehicle of telehealth by conducting a pilot randomly controlled trial (RCT) comparing a) TENACITY to b) behavioral treatment as usual (TAU; i.e., behavioral usual care). The investigators will recruit Veterans diagnosed with chronic migraine during the one-year recruitment period across the 3 VAMCs. The investigators will randomize eligible Veterans to participate either in the TENACITY intervention (n=50) or treatment as usual (n=50). The specific aims are threefold: Aim 1: To develop a bundle of evidence-based practice (EBP) implementation strategies to engage 3 VA Medical Centers \[2 Headache Centers of Excellence HCoEs and 1 general neurology service\] and facilitate their local adaptation and implementation of Cognitive Behavioral Therapy (CBT) (TENACITY) through the vehicle of telehealth services. Aim 2. To conduct a pilot RCT and determine the preliminary efficacy and feasibility of TENACITY compared to TAU across 3 VA sites. Hypothesis 2: Veterans receiving TENACITY will experience a statistically significant reduction in routine clinical headache metrics: headache frequency \[headache days per month\] (primary outcome), headache-related impairment and psychological symptoms (secondary outcomes) compared to usual care at 3 and 6 months. Aim 3: The investigators will conduct exploratory cost analysis of TENACITY from the Veteran's perspective, using inputs from the pilot RCT, and a two-year budget impact analysis from the VHA's perspective, incorporating the costs of implementation as well as direct costs (and cost-savings,) of providing the TENACITY intervention over all HCoEs to VHA. Hypothesis 3: TENACITY will be cost-effective and provide value to Veterans and VHA.
Interventions
BEHAVIORALTENACITY Telehealth Cognitive Behavioral Therapy for Migraine
Clinical health psychology therapy delivered via telehealth
BEHAVIORALBehavioral Usual Care
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participant will be randomized by mode of delivery to the telehealth or TAU treatment stratified by site (VA Medical Center). Upon completion of the baseline evaluation, the project coordinator will assign random assignment. The research assistants will be masked to random assignment.
Intervention model description
This is a randomized, controlled feasibility pilot with a single intervention arm, and a usual care control arm. The intervention arm includes participation in the TENACITY telehealth cognitive behavioral therapy CBT program for headache plus education. The usual care arm includes behavioral treatment as usual which may include outpatient clinic-based health psychology in the VA or in the community, or mindfulness sessions by LCSW.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Veteran patients eligible to participate must have: * A chronic migraine headache ICD-10 diagnosis; * Completion of at least 28 headache diary days; * A confirmed frequency of at least 8 headache days per month; * A primary complaint of headache
Exclusion criteria
Veteran patients not eligible to participate include: * Non-Veterans; * Veteran patients without a CM headache ICD-10 diagnosis; * Veteran patients whose primary pain complaint is not headache; * Veteran patients who have received greater than or equal to 90 days of opioid therapy for chronic low back pain from the date of chart screening; * Veteran patients who do not speak English; * Veteran patients who have a current diagnosis of severe cognitive impairment indicated by clinical provider, medical chart, or Short Portable Mental Status Questionnaire (SPMSQ); * Veteran patients who have Post Traumatic headache; * Veteran patients who have a diagnosis of cluster headache, other primary headache, post-whiplash headache, secondary headache, or trigeminal autonomic cephalalgia. * Any patients currently suffering from a disabling psychiatric illness (as noted by clinician); * Veteran patients who self-report Traumatic Brain Injury less than or equal to 1 year before diagnosis of Chronic Migraine, or worsening of Chronic Migraine. * Veteran patients who relate daily suicidal ideation within the last 2 weeks as indicated by the PHQ-9 with an answer of 3 to question nine; * Veteran patients who have severe depression, as indicated by PHQ-9 score greater than or equal to 20; * Veteran patients who are deemed by clinicians who are unable to participate in this trial; * Patients who are terminally ill (life expectancy of \<12 months as noted by clinician); * Patients who are homeless or live in long-term care, nursing home, rehabilitation, or domiciliary services, etc. * Veteran patients who decline to or cannot use the Annie App; * Veteran patients who decline to or cannot use My HealtheVet secure messaging * Veteran patients who have been treated by a HCoE clinical health psychologist in the last two years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Headache Days at 3 Months | 3 Months after Baseline | Daily self-reported migraine headaches using a VA text message protocol |
| Budget Impact Analysis - Cost of Training (Implementation) | 2 years | Costs associated with program implementation |
| Budget Impact Analysis - Time | 2 years | Time associated with program implementation |
| Budget Impact Analysis - Cost Per Veteran | 2 years | Costs associated with intervention per Veteran |
Other
| Measure | Time frame | Description |
|---|---|---|
| PCL-5 (Post-Traumatic Stress Disorder Checklist) | Baseline | 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. |
| Patient Health Questionnaire - PHQ-9 | 3 and 6 months | 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). |
| Migraine-Specific Quality of Life Questionnaire (MSQ) | 3 months, 6 months | 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. |
| Veterans RAND 12 (VR-12) | 3 and 6 months | 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. |
| Insomnia Severity Index (ISI) | 3 and 6 months | 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). |
| Generalized Anxiety Disorder (GAD-7) | 3 and 6 months | 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. |
| Migraine Disability Assessment (MIDAS) | 3 and 6 months | 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. |
| Headache-specific Pain Catastrophizing Scale (HPCS) | 3 and 6 months | 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. |
| Headache Management Self-Efficacy Scale (HMSE) | 3 and 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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. | 27 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3 Month Follow-up | Lost to Follow-up | 1 | 2 |
| 6 Month Follow-up | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Behavioral Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 26 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 27 Participants | 55 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 | 11 Participants | 5 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 14 Participants | 17 Participants | 31 Participants |
| Sex: Female, Male Female | 21 Participants | 19 Participants | 40 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 27 |
| other Total, other adverse events | 13 / 30 | 10 / 27 |
| serious Total, serious adverse events | 1 / 30 | 3 / 27 |
Outcome results
Primary
Budget Impact Analysis - Cost of Training (Implementation)
Costs associated with program implementation
Time frame: 2 years
Population: Summary Costs
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Budget Impact Analysis - Cost of Training (Implementation) | 12020.99 dollars |
| Behavioral Usual Care | Budget Impact Analysis - Cost of Training (Implementation) | 271.57 dollars |
Primary
Budget Impact Analysis - Cost Per Veteran
Costs associated with intervention per Veteran
Time frame: 2 years
Population: Summary Costs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Budget Impact Analysis - Cost Per Veteran | 194.46 dollars | Standard Deviation 107.47 |
| Behavioral Usual Care | Budget Impact Analysis - Cost Per Veteran | 113.52 dollars | Standard Deviation 210.4 |
Primary
Budget Impact Analysis - Time
Time associated with program implementation
Time frame: 2 years
Population: Summary Time (hours of training)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Budget Impact Analysis - Time | 201.1 hours |
| Behavioral Usual Care | Budget Impact Analysis - Time | 4.0 hours |
Primary
Number of Headache Days at 3 Months
Daily self-reported migraine headaches using a VA text message protocol
Time frame: 3 Months after Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Number of Headache Days at 3 Months | Baseline | 18.17 headache days | Standard Deviation 7.82 |
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Number of Headache Days at 3 Months | 3 months | 16.47 headache days | Standard Deviation 10.17 |
| Behavioral Usual Care | Number of Headache Days at 3 Months | Baseline | 19.19 headache days | Standard Deviation 8.54 |
| Behavioral Usual Care | Number of Headache Days at 3 Months | 3 months | 18.26 headache days | Standard Deviation 11.05 |
p-value: 0.6195% CI: [0.34, 1.97]Mixed Models Analysis
Other Pre-specified
Generalized Anxiety Disorder (GAD-7)
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.
Time frame: 3 and 6 months
Population: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Generalized Anxiety Disorder (GAD-7) | 3 months | 9.04 score on a scale | Standard Deviation 6.43 |
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Generalized Anxiety Disorder (GAD-7) | 6 months | 8.30 score on a scale | Standard Deviation 6.28 |
| Behavioral Usual Care | Generalized Anxiety Disorder (GAD-7) | 3 months | 6.78 score on a scale | Standard Deviation 4.17 |
| Behavioral Usual Care | Generalized Anxiety Disorder (GAD-7) | 6 months | 8.90 score on a scale | Standard Deviation 4.99 |
Comparison: 3 monthsp-value: 0.173395% CI: [-1.0443, 5.695]Mixed Models Analysis
Comparison: 6 monthsp-value: 0.739895% CI: [-3.7726, 2.6911]Mixed Models Analysis
Other Pre-specified
Headache Management Self-Efficacy Scale (HMSE)
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.
Time frame: 3 and 6 months
Population: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Headache Management Self-Efficacy Scale (HMSE) | 3 months | 101.09 score on a scale | Standard Deviation 26.16 |
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Headache Management Self-Efficacy Scale (HMSE) | 6 months | 103.97 score on a scale | Standard Deviation 31.04 |
| Behavioral Usual Care | Headache Management Self-Efficacy Scale (HMSE) | 3 months | 113.39 score on a scale | Standard Deviation 19.37 |
| Behavioral Usual Care | Headache Management Self-Efficacy Scale (HMSE) | 6 months | 111.00 score on a scale | Standard Deviation 23.15 |
Comparison: 3 monthsp-value: 0.087395% CI: [-27.2243, 1.8989]Mixed Models Analysis
Comparison: 6 monthsp-value: 0.286695% CI: [-21.0154, 6.2999]Mixed Models Analysis
Other Pre-specified
Headache-specific Pain Catastrophizing Scale (HPCS)
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.
Time frame: 3 and 6 months
Population: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Headache-specific Pain Catastrophizing Scale (HPCS) | 6 months | 23.55 score on a scale | Standard Deviation 18.57 |
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Headache-specific Pain Catastrophizing Scale (HPCS) | 3 months | 26.69 score on a scale | Standard Deviation 17.05 |
| Behavioral Usual Care | Headache-specific Pain Catastrophizing Scale (HPCS) | 3 months | 20.88 score on a scale | Standard Deviation 9.69 |
| Behavioral Usual Care | Headache-specific Pain Catastrophizing Scale (HPCS) | 6 months | 23.84 score on a scale | Standard Deviation 11.66 |
Comparison: 3 monthsp-value: 0.178395% CI: [-2.7794, 14.7019]Mixed Models Analysis
Comparison: 6 monthsp-value: 0.95995% CI: [-8.4965, 8.0675]Mixed Models Analysis
Other Pre-specified
Insomnia Severity Index (ISI)
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).
Time frame: 3 and 6 months
Population: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Insomnia Severity Index (ISI) | 3 months | 16.35 score on a scale | Standard Deviation 7.44 |
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Insomnia Severity Index (ISI) | 6 months | 16.91 score on a scale | Standard Deviation 8.74 |
| Behavioral Usual Care | Insomnia Severity Index (ISI) | 3 months | 13.28 score on a scale | Standard Deviation 6.45 |
| Behavioral Usual Care | Insomnia Severity Index (ISI) | 6 months | 14.86 score on a scale | Standard Deviation 5.48 |
Comparison: 3 monthsp-value: 0.144295% CI: [-1.0852, 7.2849]Mixed Models Analysis
Comparison: 6 monthsp-value: 0.313295% CI: [-1.9892, 6.1243]Mixed Models Analysis
Other Pre-specified
Migraine Disability Assessment (MIDAS)
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.
Time frame: 3 and 6 months
Population: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Migraine Disability Assessment (MIDAS) | 3 months | 83.09 score on a scale | Standard Deviation 68.72 |
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Migraine Disability Assessment (MIDAS) | 6 months | 63.17 score on a scale | Standard Deviation 61.88 |
| Behavioral Usual Care | Migraine Disability Assessment (MIDAS) | 3 months | 64.94 score on a scale | Standard Deviation 47.59 |
| Behavioral Usual Care | Migraine Disability Assessment (MIDAS) | 6 months | 68.68 score on a scale | Standard Deviation 61.4 |
Comparison: 3 monthsp-value: 0.302195% CI: [-17.2261, 54.8032]Mixed Models Analysis
Comparison: 6 monthsp-value: 0.762495% CI: [-39.3245, 28.9254]Mixed Models Analysis
Other Pre-specified
Migraine-Specific Quality of Life Questionnaire (MSQ)
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.
Time frame: 3 months, 6 months
Population: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Migraine-Specific Quality of Life Questionnaire (MSQ) | 3 months | 48.39 score on a scale | Standard Deviation 23.07 |
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Migraine-Specific Quality of Life Questionnaire (MSQ) | 6 months | 48.79 score on a scale | Standard Deviation 24.29 |
| Behavioral Usual Care | Migraine-Specific Quality of Life Questionnaire (MSQ) | 3 months | 57.06 score on a scale | Standard Deviation 19.36 |
| Behavioral Usual Care | Migraine-Specific Quality of Life Questionnaire (MSQ) | 6 months | 53.32 score on a scale | Standard Deviation 16.72 |
Comparison: 3 monthp-value: 0.172495% CI: [-21.5314, 3.9257]Mixed Models Analysis
Comparison: 6 monthsp-value: 0.439995% CI: [-16.5917, 7.2851]Mixed Models Analysis
Other Pre-specified
Patient Health Questionnaire - PHQ-9
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).
Time frame: 3 and 6 months
Population: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Patient Health Questionnaire - PHQ-9 | 3 months | 9.27 score on a scale | Standard Deviation 6.28 |
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Patient Health Questionnaire - PHQ-9 | 6 months | 8.61 score on a scale | Standard Deviation 5.46 |
| Behavioral Usual Care | Patient Health Questionnaire - PHQ-9 | 6 months | 7.88 score on a scale | Standard Deviation 4.88 |
| Behavioral Usual Care | Patient Health Questionnaire - PHQ-9 | 3 months | 10.83 score on a scale | Standard Deviation 5.11 |
Comparison: 3 monthsp-value: 0.277695% CI: [-4.4168, 1.2859]Mixed Models Analysis
Comparison: 6 monthsp-value: 0.663695% CI: [-2.5651, 4.0055]Mixed Models Analysis
Other Pre-specified
PCL-5 (Post-Traumatic Stress Disorder Checklist)
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | PCL-5 (Post-Traumatic Stress Disorder Checklist) | 33.29 score on a scale | Standard Deviation 17.62 |
| Behavioral Usual Care | PCL-5 (Post-Traumatic Stress Disorder Checklist) | 29.25 score on a scale | Standard Deviation 20.67 |
Other Pre-specified
Veterans RAND 12 (VR-12)
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.
Time frame: 3 and 6 months
Population: The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Veterans RAND 12 (VR-12) | Physical Component Scale - 3 months | 41.84 score on a scale | Standard Deviation 5.14 |
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Veterans RAND 12 (VR-12) | Physical Component Scale - 6 months | 39.93 score on a scale | Standard Deviation 5.9 |
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Veterans RAND 12 (VR-12) | Mental Component Scale - 3 months | 34.56 score on a scale | Standard Deviation 10.15 |
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Veterans RAND 12 (VR-12) | Mental Component Scale - 6 months | 35.02 score on a scale | Standard Deviation 7.78 |
| Behavioral Usual Care | Veterans RAND 12 (VR-12) | Mental Component Scale - 6 months | 38.02 score on a scale | Standard Deviation 6.15 |
| Behavioral Usual Care | Veterans RAND 12 (VR-12) | Physical Component Scale - 3 months | 41.94 score on a scale | Standard Deviation 4.15 |
| Behavioral Usual Care | Veterans RAND 12 (VR-12) | Mental Component Scale - 3 months | 34.81 score on a scale | Standard Deviation 5.95 |
| Behavioral Usual Care | Veterans RAND 12 (VR-12) | Physical Component Scale - 6 months | 40.20 score on a scale | Standard Deviation 4.85 |
Comparison: Physical Component Scale - 3 monthsp-value: 0.923995% CI: [-3.2476, 2.9494]Mixed Models Analysis
Comparison: Physical Component Scale - 6 monthsp-value: 0.845695% CI: [-3.2238, 2.6481]Mixed Models Analysis
Comparison: Mental Component Scale - 3 monthsp-value: 0.941395% CI: [-4.9175, 4.5661]Mixed Models Analysis
Comparison: Mental Component Scale - 6 monthsp-value: 0.193495% CI: [-7.4526, 1.5333]Mixed Models Analysis