Interactive CBT for Headache And Relaxation Training (iCHART)

Interactive CBT for Headache And Relaxation Training (iCHART)

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.

Study Overview

• Status: Terminated
• Conditions: Post-Traumatic Headache
• Intervention / Treatment: Behavioral: iCHART - Interactive CBT for Headache And Relaxation Training

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VACHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Veterans RAND 12-item Health Survey (VR-12)	A 12-item, self-report measure of health-related quality life in terms of physical and mental health domains. Scores are summed into a physical health and mental health summary score and standardized using a T-score metric with a mean of 50 and a standard deviation of 10.	Baseline, week 10, and week 14
Patient Health Questionnaire 8-item (PHQ-8)	An 8-item, self-report measure of depressive symptom severity based on DSM criteria. Items are rated from 0 to 3 (0 = not at all to 3 = nearly every day). Total scores range from 0 to 27. Cut points represent thresholds for non-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27) depression.	Baseline, week 10, and week 14
Generalized Anxiety Disorder Screener (GAD-7)	A 7-item, self-report measure of anxiety. Items are rated from 0 to 3 (0 = not at all to 3 = nearly every day). Total scores range from 0 to 21. Cut points represent thresholds for none-minimal (0-4), mild (5-9), moderate (10-14) and severe (15-21).	Baseline, week 10, and week 14
Post-Traumatic Stress Disorder Checklist (PCL)	A 17-tem, self-report measure of symptoms of PTSD based on Diagnostic and Statistical Manual (DSM) criteria. Items are rated from 0 to 4 (0= Not at all to 4 = Extremely). Total scores range from 17-85.	Baseline, week 10, and week 14
Insomnia Severity Index (ISI)	A 5-item self-report measure of symptoms of insomnia. Total scores range from 0 to 28. Cut points represent thresholds for no clinically significant insomnia (0-7), subthreshold insomnia (8-14), clinical insomnia (moderately severe) (15-21), clinical insomnia (severe) (22-28).	Baseline, week 10, and week 14
Headache Pain Catastrophizing Scale (HPCS)	A modified version of the Pain Catastrophizing Scale (use of word headache vs. pain in the questions). The HPCS is a 13-item self-report measure of catastrophic thinking related to headache. Items are rated from 0 to 4 (0= not at all to 4 - all the time). Total scores range from 0 to 52, with subscale scores for rumination, magnification, and helplessness.	Baseline, week 10, and week 14
Headache Management Self-Efficacy Scale (HMSE)	A 25-item self-report questionnaire related to a person's confidence in their ability to manage their headache symptoms. Items range from 1 to 7 (1=strongly disagree to 7 = strongly disagree). Total scores range from 25 to 175	Baseline, week 10, and week 14
Patient Global Perception of Change (PGPC)	single item scale measures the participant's perception of improvement since the start of the study. Participants respond to the single item on a 7-point scale (1 = very much improved to 7 = very much worse). This measure shows good psychometric properties.	Week 10
Client Satisfaction Questionnaire-8 (CSQ-8)	An 8-item self-report measure of treatment acceptability and satisfaction with mental health treatment. Items are coded on a 4-point scale. Total scores are calculated by summing up items, with scores ranging from 8 to 32	Week 10
System Usability Scale (SUS)	A 10-item measure of treatment acceptability. The SUS assesses participant perceived usability of technology systems. Response options range from 1 to 5, with 50% of the items being positively worded and 50% negatively worded. Scores are converted to an overall score from 0 to 100. Higher scores indicate higher perceived usability	Week 10
Acceptability of Intervention (AIM)	A 4-item measure of treatment acceptability. Items are score on a 5-point scale. Scores are a calculated mean. Higher scores indicate greater acceptability	Week 10
Structured Assessment of Feasibility Questionnaire (SAFE)	A 16-item measure of feasibility of mental health services, organized into two sections. The first eight questions assess barriers to implementation, the final eight assess facilitators to implementation. Items are rated as either yes, partial, no, or unable to rate, with each individual item attended to. It is recommended against using a summary score, since items within the sale may have unequal weight.	Week 10
Feasibility of Intervention Measure (FIM)	A 4-item measure of feasibility. Items are rated on a 5-point Likert scale. Scores are a calculated mean. Higher scores indicate greater feasibility	Week 10

Collaborators and Investigators

• Sponsor: VA Connecticut Healthcare System
• Investigators: Principal Investigator: Amy Grinberg, PhD, VA Connecticut Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache
• Other Study ID Numbers: AG001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No