PTSD Clinical Trial
Official title:
Coalition to Alleviate PTSD: Randomized Clinical Trial of Cognitive-Behavior Therapy for Posttraumatic Headache
Verified date | September 2020 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall purpose of the study is to compare two talk therapies (Clinic-Based Cognitive Behavioral Therapy and Cognitive Processing Therapy-Cognitive Only) for the treatment of posttraumatic headache (PTHA) and co-morbid posttraumatic stress (PTS). The researchers hope to learn if a non-medication, cognitive-behavioral treatment can result in noticeable reductions in PTHA intensity/severity and frequency as well as PTS symptom severity.
Status | Completed |
Enrollment | 192 |
Est. completion date | October 10, 2019 |
Est. primary completion date | May 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - adult (ages 18 - 70 years old) - U.S. military Veterans with military service during Operations Enduring Freedom (OEF), Iraqi Freedom (OIF), and New Dawn (OND) - have sustained a traumatic head injury - have been diagnosed or report symptoms consistent with chronic (> 3 months) posttraumatic headache attributed to a traumatic injury sustained as part of military service. We are focusing on chronic PTHA due to the very low likelihood of headache remission after 3 months, the disability associated with chronic PTHA, and the high prevalence of chronic versus acute PTHA in this Veteran population. A positive PTHA diagnosis will be indicated for individuals with de novo headache onset within 3 months of a concussion or exacerbation of pre-existing headache symptoms (increased frequency, duration, or intensity) within 3 months of traumatic injury. This is consistent with the existing ICHD-III criteria for PTHA inclusion will be based on either a pre-existing diagnosis of chronic PTHA documented in the Veteran's medical record by a PRC/PSC provider or a Neurologist (e.g., ICD-10 code G44.329) or through screening with one of our PRC/PSC co-PIs if the Veteran reports symptoms consistent with chronic PTHA but has never had it documented in her/his medical record. - Participants taking headache medication with a stable pattern of use for the prior 6 week period (including no prescribed changes in medical regimen). - Participants must have some posttraumatic stress (PTS) symptoms based on a cut-off score of at least 25 or above on the PTSD CheckList -Version (PCL-5), which all participants will complete as part of their screening. - Participants must also report on the Clinician Administered PTSD Scale (CAPS-5) an exposure to a traumatic event (Criterion A), at least one intrusion symptom (Criterion B), and at least one avoidance symptom (Criterion C). There is some evidence suggesting 40% comorbidity between PTSD and new onset headache, so it is reasonable to assume that at least half of all PTHA participants recruited for this study will have PTHA and comorbid PTS symptoms. The inclusion of PTS symptoms in this sample is vital based on reports indicating that PTS symptoms and PTSD actually increase vulnerability to PTHA and chronic headache in military populations Exclusion Criteria: - there has been a recent and significant change in the nature of headache symptoms over the last 6 weeks prior to their screening (as determined by the investigators) - Participants currently in CPT or prolonged exposure for PTSD. - Participant has medication overuse headache as defined by the Structured Diagnostic Headache Interview-Revised (Brief Version; SDIHR). - the participant is unable to read or speak English at a 6th grade level - they have had a psychiatric hospitalization in the last 12 months - they currently meet a psychiatric diagnosis of substance abuse [based on Alcohol Use Disorders Identification Test (AUDIT) assessment during screening] - they are pregnant or plan to become pregnant during the trial (due to concerns about pregnancy-induced headache that may obscure findings) - if a psychiatric problem is present that warrants immediate treatment based upon clinical judgment - if they demonstrate significant cognitive impairment that could impact treatment adherence/benefit. |
Country | Name | City | State |
---|---|---|---|
United States | San Antonio VA Medical Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio | Wake Forest University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Headache-related disability scores on the Headache Impact Test 6 (HIT-6) | Change in baseline headache-related disability will be assessed over time based on headache-related disability scores on the HIT-6 obtained at multiple time points: at the end of 6 weeks of treatment, and at 3 and 6 months post-treatment. | Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment | |
Primary | Scores for symptoms of post-traumatic stress on the PTSD Checklist-5 (PCL-5) | Change in baseline post-traumatic stress scores will be assessed over time | Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment | |
Secondary | Frequency of headache reported in daily diary records | Change in headache frequency over time (averaged over two-week intervals) from baseline, at the completion of 6 weeks of treatment, and at 3 and 6 months post-treatment. Participants will complete headache diaries twice daily (am and pm) via a secure online patient reporting website developed for this study and managed by study staff. A total of 168 daily diary entries will be collected during the study period | Twice daily for two weeks at baseline, twice daily during 6 weeks of treatment, and twice daily for two week periods at 3 and 6 months post-treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03962504 -
Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial
|
N/A | |
Completed |
NCT01995123 -
Behavioral Activation for Smoking Cessation in PTSD
|
N/A | |
Not yet recruiting |
NCT06278922 -
Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma
|
N/A | |
Completed |
NCT04597450 -
Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)
|
Phase 1 | |
Completed |
NCT03593772 -
Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD
|
N/A | |
Completed |
NCT03429166 -
Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
|
N/A | |
Recruiting |
NCT04317820 -
Deep Brain Reorienting in Post-traumatic Stress Disorder
|
N/A | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Completed |
NCT03504722 -
Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD
|
N/A | |
Completed |
NCT04305353 -
Intensive Care Unit (ICU) Diary Project
|
N/A | |
Completed |
NCT03113890 -
McLean and Genomind Prospective Study
|
N/A | |
Withdrawn |
NCT05173831 -
Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans
|
Phase 2 | |
Withdrawn |
NCT03924297 -
Chilipad for Sleep and Symptoms of PTSD
|
N/A | |
Not yet recruiting |
NCT04056767 -
Changes in Digital Phenotype During PE Therapy
|
||
Withdrawn |
NCT03216356 -
Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD
|
Phase 2/Phase 3 | |
Completed |
NCT03343028 -
Biomarker Establishment for Superior Treatment of PTSD
|
||
Completed |
NCT03158558 -
Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD
|
N/A | |
Completed |
NCT02370173 -
A Non-Pharmacological Method for Enhancing Sleep in PTSD
|
N/A | |
Completed |
NCT01911585 -
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
|
N/A | |
Withdrawn |
NCT01957371 -
Mindful Yoga Therapy for Veterans With PTSD and Pain
|
N/A |