NCT05093556

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 6, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

1.7 years

First QC Date

September 22, 2021

Last Update Submit

January 8, 2024

Conditions

Post-Traumatic Headache

Outcome Measures

Primary Outcomes (1)

  • Change in headache days

    Daily self-reported headache days

    Baseline and week 14

Secondary Outcomes (2)

  • Change in headache-related disability

    Baseline and week 14

  • Change in headache-related disability

    Baseline and week 14

Other Outcomes (13)

  • Veterans RAND 12-item Health Survey (VR-12)

    Baseline, week 10, and week 14

  • Patient Health Questionnaire 8-item (PHQ-8)

    Baseline, week 10, and week 14

  • Generalized Anxiety Disorder Screener (GAD-7)

    Baseline, week 10, and week 14

  • +10 more other outcomes

Study Arms (1)

iCHART - Interactive CBT for Headache And Relaxation Training

EXPERIMENTAL

10 week interactive-voice response technology (IVR) based cognitive behavioral therapy for headache

Behavioral: iCHART - Interactive CBT for Headache And Relaxation Training

Interventions

iCHART - Interactive CBT for Headache And Relaxation TrainingBEHAVIORAL

IVR based cognitive behavioral therapy for headache

iCHART - Interactive CBT for Headache And Relaxation Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VACHS

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

  • 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.

    PMID: 40657938DERIVED

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Amy Grinberg, PhD

    VA Connecticut Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 26, 2021

Study Start

January 6, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations

US(1)