Post-Traumatic HeadacheiCHARTNCT05093556
Interactive CBT for Headache And Relaxation Training
A study testing iCHART - Interactive CBT for Headache And Relaxation Training in people with Post-Traumatic Headache, run by VA Connecticut Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Headache
- What is being tested?
- iCHART - Interactive CBT for Headache And Relaxation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-Traumatic Headache
- Being tested
- iCHART - Interactive CBT for Headache And Relaxation Training
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCHART - Interactive CBT for Headache And Relaxation TrainingBehavioural
IVR based cognitive behavioral therapy for headache
| Study group | Role | What they receive |
|---|---|---|
| iCHART - Interactive CBT for Headache And Relaxation Training | Experimental | 10 week interactive-voice response technology (IVR) based cognitive behavioral therapy for headache Receives: Behavioral: iCHART - Interactive CBT for Headache And Relaxation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in headache days
Daily self-reported headache days
Measured: Baseline and week 14
Secondary outcomes (2)
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.
Measured: 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+).
Measured: Baseline and week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start6 Jan 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Why it stopped: Change in vendor security protocols would have necessitated changing platforms and rebuilding entire IVR platform which would have delayed patient recruitment and introduced heterogeneity across subjects using current and new platforms
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amy Grinberg, PhD, Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093556
- Sponsor's protocol ID
- AG001
- Acronym
- iCHART
- Status last verified
- Jan 2024
- First submitted
- 22 Sep 2021
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grinberg AS, Rogers DG, Datre O, Anthony S, Clark SW, Takagishi SC, Seng E, Fenton BT, Ney JP, Sico JJ. Interactive CBT for headache and relaxation training (iCHART): Single-arm pilot trial of cognitive behavioral therapy for veterans with post-traumatic headache. Cephalalgia. 2025 Jul;45(7):3331024251351598. doi: 10.1177/03331024251351598. Epub 2025 Jul 14.
PubMed 40657938
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive CBT for Headache And Relaxation Training (iCHART)
- ClinicalTrials.gov ID
- NCT05093556
- Acronym / sponsor ID
- iCHART / AG001
- Conditions
- Post-Traumatic Headache
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in vendor security protocols would have necessitated changing platforms and rebuilding entire IVR platform which would have delayed patient recruitment and introduced heterogeneity across subjects using current and new platforms
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iCHART - Interactive CBT for Headache And Relaxation Training | Experimental | Behavioral: iCHART - Interactive CBT for Headache And Relaxation Training10 week interactive-voice response technology (IVR) based cognitive behavioral therapy for headache |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Non-English speaking
- Non-Veteran
- Receiving hospice or palliative care
- Sensory deficits that would impair participation in the IVR telephone calls
- Significant cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCHART - Interactive CBT for Headache And Relaxation TrainingIVR based cognitive behavioral therapy for headache | Behavioural | iCHART - Interactive CBT for Headache And Relaxation Training |
Primary outcome
Change in headache days
Time frame: Baseline and week 14
Daily self-reported headache days
2 secondary outcomes
Change in headache-related disability
Time frame: Baseline and week 14
Change in headache-related disability
Time frame: Baseline and week 14
Results and safety
The study was stopped early (reason given: Change in vendor security protocols would have necessitated changing platforms and rebuilding entire IVR platform which would have delayed patient recruitment and introduced heterogeneity across subjects using current and new platforms). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 40657938Grinberg AS, Rogers DG, Datre O, Anthony S, Clark SW, Takagishi SC, Seng E, Fenton BT, Ney JP, Sico JJ. Interactive CBT for headache and relaxation training (iCHART): Single-arm pilot trial of cognitive behavioral therapy for veterans with post-traumatic headache. Cephalalgia. 2025 Jul;45(7):3331024251351598. doi: 10.1177/03331024251351598. Epub 2025 Jul 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Grinberg, PhD principal investigator
VA Connecticut Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCHART - Interactive CBT for Headache And Relaxation Training in people with Post-Traumatic Headache, run by VA Connecticut Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in vendor security protocols would have necessitated changing platforms and rebuilding entire IVR platform which would have delayed patient recruitment and introduced heterogeneity across subjects using current and new platforms). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in headache days (time frame: Baseline and week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05093556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.