Behavior Therapy vs Education for Persistent Headache After Mild TBI

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

This study will test a new treatment, called Headache reprocessing, for persistent post-traumatic headache. The new treatment will be compared to a headache education intervention. The main objectives of the study are to examine the feasibility, safety, and clinical appropriateness of the new treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Enrolled in healthcare at VA San Diego Healthcare System;

History of mild TBI (mTBI), or head injury that is below the diagnostic threshold for mTBI

Headache that had its lifetime onset or significantly worsened within 90 days of a concussive event

Headache has persisted for at least 90 days since its onset or worsening

Disqualifiers

History of moderate or severe traumatic brain injury

Uncontrolled bipolar, psychotic, or substance use disorder

Acute suicidality as determined by screening as "high risk" or has a history of suicide attempt within the past 1 year;

Other factors that would preclude participation in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Headache reprocessing

    Behavioral

    Behavior therapy focused on sensations and avoidance behaviors

  • Headache education

    Behavioral

    Education about ways to limit and manage headaches

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Headache reprocessingExperimental treatment 1 intervention
Group B: Headache educationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Enrollment rate

Number enrolled out of number approached

Time frame
Typically up to 3 months, from initial referral to decision to enroll or not
2

Attrition

% of randomized who are lost to follow-up before week 12

Time frame
12 weeks
3

Attendance

Percent of participants attending 80+% of sessions

Time frame
During the 8-week intervention
4

Homework completion

Percent of participants completing 80+% of homework

Time frame
During the 8-week intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: