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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Experimental | 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. |
|
| Behavioral Usual Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | Behavioral | Clinical health psychology therapy delivered via telehealth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Headache Days at 3 Months | Daily self-reported migraine headaches using a VA text message protocol | 3 Months after Baseline |
| Budget Impact Analysis - Cost of Training (Implementation) | Costs associated with program implementation | 2 years |
| Budget Impact Analysis - Time | Time associated with program implementation | 2 years |
| Budget Impact Analysis - Cost Per Veteran | Costs associated with intervention per Veteran | 2 years |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months, 6 months |
| Migraine Disability Assessment (MIDAS) |
Inclusion Criteria:
Veteran patients eligible to participate must have:
Exclusion Criteria:
Veteran patients not eligible to participate include:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa M. Damush, PhD | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham VA Medical Center, Birmingham, AL | Birmingham | Alabama | 35233 | United States | ||
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35293614 | Result | Goldman RE, Damush TM, Kuruvilla DE, Lindsey H, Baird S, Riley S, Burrone Bs L, Grinberg AS, Seng EK, Fenton BT, Sico JJ. Essential components of care in a multidisciplinary headache center: Perspectives from headache neurology specialists. Headache. 2022 Mar;62(3):306-318. doi: 10.1111/head.14277. Epub 2022 Mar 16. | |
| 36100439 | Result |
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After the study completion and the planned and secondary analyses are published by the study team, a limited de-identified data set will be made available upon request for a limited period.
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To be determined
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period |
| |||||||||||||||||||
| 3 Month Follow-up |
| |||||||||||||||||||
| 6 Month Follow-up |
|
Veteran patients with a migraine headache diagnosis receiving care in the Veterans Healthcare Administration and had confirmed chronic headache through a headache diary.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Headache Days at 3 Months | Daily self-reported migraine headaches using a VA text message protocol | Posted | Mean | Standard Deviation | headache days | 3 Months after Baseline |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| colitis | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| allergic reaction | Immune system disorders | Non-systematic Assessment |
Limitations include not reaching the target number of participants needed to achieve sufficient statistical power. We initially consented 80 participants of which 57 of the 80 were eligible to be randomized based on the 30 day headache diary outcomes confirming chronic headache. The study was conducted during the COVID-19 pandemic. Thus, the enhanced headache usual treatment was often offered via telehealth.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Teresa Damush | Richard L. Roudebush VA Medical Center | 317-988-4277 | teresa.damush@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2022 | Jun 27, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 3, 2022 | Sep 28, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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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.
| Behavioral Usual Care | Behavioral | Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. |
|
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. |
| 3 and 6 months |
| 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. | 3 and 6 months |
| 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. | 3 and 6 months |
| 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. | Baseline |
| 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). | 3 and 6 months |
| 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. | 3 and 6 months |
| 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. | 3 and 6 months |
| 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). | 3 and 6 months |
| West Haven |
| Connecticut |
| 06516 |
| United States |
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2884 | United States |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas | 75216 | United States |
| Seng EK, Fenton BT, Wang K, Lipton RB, Ney J, Damush T, Grinberg AS, Skanderson M, Sico JJ. Frequency, Demographics, Comorbidities, and Health Care Utilization by Veterans With Migraine: A VA Nationwide Cohort Study. Neurology. 2022 Oct 31;99(18):e1979-e1992. doi: 10.1212/WNL.0000000000200888. |
| 42266645 | Derived | Damush TM, Calcatera SM, Datre O, Hayley L, Austin C, Schlitz EL, Eubanks CL, Harrison L, Yuan D, Taylor S, Flanagan M, Ney J, Seng EK, Sico JJ, Grinberg AS. Telemedicine-based cognitive behavioral therapy (TENACITY) for Veterans with chronic migraine: A pilot randomized controlled trial protocol. Cephalalgia Rep. 2025 Sep 1;8:10.1177/25158163251374156. doi: 10.1177/25158163251374156. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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.
|
|
|
| Primary | Budget Impact Analysis - Cost of Training (Implementation) | Costs associated with program implementation | Summary Costs | Posted | Number | dollars | 2 years |
|
|
|
| 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. | The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months |
|
|
|
|
| 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. | The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey. | Posted | Mean | Standard Deviation | score on a scale | 3 and 6 months |
|
|
|
|
| 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. | The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey. | Posted | Mean | Standard Deviation | score on a scale | 3 and 6 months |
|
|
|
|
| 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. | The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey. | Posted | Mean | Standard Deviation | score on a scale | 3 and 6 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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). | The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey. | Posted | Mean | Standard Deviation | score on a scale | 3 and 6 months |
|
|
|
|
| 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. | The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey. | Posted | Mean | Standard Deviation | score on a scale | 3 and 6 months |
|
|
|
|
| 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. | The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey. | Posted | Mean | Standard Deviation | score on a scale | 3 and 6 months |
|
|
|
|
| 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). | The number analyzed in one or more rows differs from overall number analyzed because some participants chose to not complete the survey. | Posted | Mean | Standard Deviation | score on a scale | 3 and 6 months |
|
|
|
|
| Primary | Budget Impact Analysis - Time | Time associated with program implementation | Summary Time (hours of training) | Posted | Number | hours | 2 years |
|
|
|
| Primary | Budget Impact Analysis - Cost Per Veteran | Costs associated with intervention per Veteran | Summary Costs | Posted | Mean | Standard Deviation | dollars | 2 years |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| 13 |
| 30 |
| EG001 | 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. | 0 | 27 | 3 | 27 | 10 | 27 |
| stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| flu | Infections and infestations | Non-systematic Assessment |
|
| arm/leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| chest pain | Cardiac disorders | Non-systematic Assessment |
|
| GERD | Gastrointestinal disorders | Non-systematic Assessment |
|
| COVID | Infections and infestations | Non-systematic Assessment |
|
| dehydration | General disorders | Non-systematic Assessment |
|
| depressive symptoms | Psychiatric disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| fever | Infections and infestations | Non-systematic Assessment |
|
| flu | Infections and infestations | Non-systematic Assessment |
|
| foot pain | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| hives | Immune system disorders | Non-systematic Assessment |
|
| insomnia | General disorders | Non-systematic Assessment |
|
| irregular heartbeat | Cardiac disorders | Non-systematic Assessment |
|
| leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| migraine | General disorders | Non-systematic Assessment |
|
| pain symptoms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| plantar wart | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| PTSD | Psychiatric disorders | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| shoulder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| sinus infection | Infections and infestations | Non-systematic Assessment |
|
| stomach virus | Infections and infestations | Non-systematic Assessment |
|
| superficial burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| 6 months |
|
|
| 0.4399 |
| Mean Difference (Net) |
| -4.6533 |
| Standard Error of the Mean |
| 5.9929 |
| 2-Sided |
| 95 |
| -16.5917 |
| 7.2851 |
| Superiority |
| 6 months |
|
|
| 0.7624 |
| Mean Difference (Net) |
| -5.1996 |
| Standard Error of the Mean |
| 17.1338 |
| 2-Sided |
| 95 |
| -39.3245 |
| 28.9254 |
| Superiority |
| 6 months |
|
|
| 0.959 |
| Mean Difference (Net) |
| -0.2145 |
| Standard Error of the Mean |
| 4.1565 |
| 2-Sided |
| 95 |
| -8.4965 |
| 8.0675 |
| Superiority |
| 6 months |
|
|
| 0.2866 |
| Mean Difference (Net) |
| -7.3578 |
| Standard Error of the Mean |
| 6.8559 |
| 2-Sided |
| 95 |
| -21.0154 |
| 6.2999 |
| Superiority |
| 6 months |
|
|
| 0.6636 |
| Mean Difference (Net) |
| 0.7202 |
| Standard Error of the Mean |
| 1.6492 |
| 2-Sided |
| 95 |
| -2.5651 |
| 4.0055 |
| Superiority |
| 6 months |
|
|
| 0.7398 |
| Mean Difference (Net) |
| -0.5408 |
| Standard Error of the Mean |
| 1.622 |
| 2-Sided |
| 95 |
| -3.7726 |
| 2.6911 |
| Superiority |
| Physical Component Scale - 6 months |
|
|
| Mental Component Scale - 3 months |
|
|
| Mental Component Scale - 6 months |
|
|
| Mixed Models Analysis |
| 0.8456 |
| Mean Difference (Net) |
| -0.2879 |
| Standard Error of the Mean |
| 1.4735 |
| 2-Sided |
| 95 |
| -3.2238 |
| 2.6481 |
| Superiority |
| Mental Component Scale - 3 months | Mixed Models Analysis | 0.9413 | Mean Difference (Net) | -0.1757 | Standard Error of the Mean | 2.3798 | 2-Sided | 95 | -4.9175 | 4.5661 | Superiority |
| Mental Component Scale - 6 months | Mixed Models Analysis | 0.1934 | Mean Difference (Net) | -2.9597 | Standard Error of the Mean | 2.2549 | 2-Sided | 95 | -7.4526 | 1.5333 | Superiority |
| 6 months |
|
|
| 0.3132 |
| Mean Difference (Net) |
| 2.0675 |
| Standard Error of the Mean |
| 2.036 |
| 2-Sided |
| 95 |
| -1.9892 |
| 6.1243 |
| Superiority |