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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05093556
Other study ID # AG001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 6, 2022
Est. completion date October 1, 2023

Study information

Verified date January 2024
Source VA Connecticut Healthcare System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
iCHART - Interactive CBT for Headache And Relaxation Training
IVR based cognitive behavioral therapy for headache

Locations

Country Name City State
United States VACHS West Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Primary Change in headache days Daily self-reported headache days Baseline and week 14
Secondary 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
Secondary 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
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