Interactive CBT for Headache And Relaxation Training

Study Overview
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Brief Summary
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This mixed-methods pilot study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of iCHART (Interactive CBT for Headache And Relaxation Training), an interactive voice response (IVR) based delivery of cognitive behavioral therapy for Veterans with post-traumatic headache. Participants will receive iCHART treatment through the IVR system over a period of 10 weeks, which will include an automated daily assessment of patient-reported outcomes, retrieval of fortnightly tailored feedback from a study therapist, and additional weekly one-way motivational enhancement messaging. Delivery of traditional evidence-based behavioral treatments for headache management through technology-based interventions, such as IVR may ultimately increase much needed access to these treatments and allow patients to receive care at a time that is convenient for them.

Detailed Description
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Headache disorders are prevalent and highly disabling chronic neurological pain conditions, especially among women and people with traumatic brain injury, yet remain underdiagnosed and undertreated. Cognitive behavioral therapy for headache is an evidence-based psychological treatment that is effective in reducing headache frequency and severity, addressing psychiatric comorbidities, and improving an individual's quality of life, yet it remains hugely underutilized and inaccessible to many. Delivery of traditional evidence-based behavioral treatments for headache management through technology-based interventions may ultimately increase much needed access to these treatments. Interactive voice response (IVR) is an automated telephone-based technology where people receive tailored messaging which allows them to track symptoms, target behavior change, and engage in disease self-management. This mixed-methods pilot study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of iCHART (Interactive CBT for Headache And Relaxation Training), an IVR-based delivery of cognitive behavioral therapy for Veterans with headache. Participants will be thirty-five Veterans receiving care within VA Connecticut Healthcare System, who are diagnosed with post-traumatic headache. All eligible participants will complete an initial intake interview and a 28-day electronic headache diary. Following the baseline assessment period, eligible participants will then receive iCHART treatment through the IVR system over a period of 10 weeks, which will include an automated daily assessment of patient-reported outcomes, retrieval of fortnightly tailored feedback from a study therapist, and additional weekly one-way motivational enhancement messaging. Participants will access a patient workbook via the iCHART study website and iCHART providers will visualize patient-reported data through the secure iCHART provider dashboard. Assessment measures will be completed at baseline, immediately post-treatment completion, and one month post-treatment completion. Analysis of primary and secondary outcome measures will employ mixed methods.

Official Title
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Interactive CBT for Headache And Relaxation Training (iCHART)

Conditions
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Post-Traumatic Headache

Intervention / Treatment
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* Behavioral: iCHART - Interactive CBT for Headache And Relaxation Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of post-traumatic headache disorder (migraine and/or tension-type subtype) Frequency of ≥4 headache days per month Primary pain complaint of headache Access to a touchtone telephone and computer/tablet Exclusion Criteria: Non-English speaking Non-Veteran Receiving hospice or palliative care Sensory deficits that would impair participation in the IVR telephone calls Significant cognitive impairment Inpatient psychiatric hospitalization for any psychiatric or substance use diagnosis in the past 30 days from screening Active psychotic symptoms, suicidality, or severe depressive symptoms Suicidal and/or homicidal ideation in the past 6 months from screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCHART - Interactive CBT for Headache And Relaxation Training<br>10 week interactive-voice response technology (IVR) based cognitive behavioral therapy for headache | Behavioral: iCHART - Interactive CBT for Headache And Relaxation Training<br>* IVR based cognitive behavioral therapy for headache<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in headache days | Daily self-reported headache days | Baseline and week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in headache-related disability | Headache Disability Inventory (HDI) is a 25-item self-report questionnaire that assesses both emotional and functional impact of headache on daily activities. Item response options include yes, sometimes, and no. Total scores range from 0 to 100. Higher scores indicate higher levels of reported disability. | Baseline and week 14 | 
| Change in headache-related disability | Migraine Disability Assessment (MIDAS) is a 5-item, self-report measure of life disruption due to headache. Cut points represent thresholds for little or no disability (0-5), mild disability (6-10), moderate disability (11-20), and severe disability (21+). | Baseline and week 14 |