Clinical trial NCT05093556: Interactive CBT for Headache And Relaxation Training
Official title: Interactive CBT for Headache And Relaxation Training (iCHART)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-Traumatic Headache
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2021-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in headache days
timeFrame: Baseline and week 14
Secondary outcomes:
measure: Change in headache-related disability
timeFrame: Baseline and week 14
measure: Change in headache-related disability
timeFrame: Baseline and week 14
Other outcomes:
measure: Veterans RAND 12-item Health Survey (VR-12)
timeFrame: Baseline, week 10, and week 14
measure: Patient Health Questionnaire 8-item (PHQ-8)
timeFrame: Baseline, week 10, and week 14
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: Baseline, week 10, and week 14
measure: Post-Traumatic Stress Disorder Checklist (PCL)
timeFrame: Baseline, week 10, and week 14
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, week 10, and week 14
measure: Headache Pain Catastrophizing Scale (HPCS)
timeFrame: Baseline, week 10, and week 14
measure: Headache Management Self-Efficacy Scale (HMSE)
timeFrame: Baseline, week 10, and week 14
measure: Patient Global Perception of Change (PGPC)
timeFrame: Week 10
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Week 10
measure: System Usability Scale (SUS)
timeFrame: Week 10
measure: Acceptability of Intervention (AIM)
timeFrame: Week 10
measure: Structured Assessment of Feasibility Questionnaire (SAFE)
timeFrame: Week 10
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Week 10
Locations:
city: West Haven
country: United States
facility: VACHS
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Amy Grinberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: