Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551987
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cognitive Behavioral Therapy for Insomnia Vs Brief Behavioral Therapy for Insomnia in Military Personnel with Postconcussive Symptoms Following Mild Traumatic Brain Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single site two-armed random controlled trials RCT comparing six sessions of Cognitive Behavioral Therapy for Insomnia CBT-I with four sessions of Brief Behavioral Therapy for Insomnia BBT-I in service members with comorbid insomnia and prolonged postconcussive symptoms present for at least 3 months after Mild Traumatic Brain Injury mTBI
Detailed Description:
The purpose of this study is to identify the optimal behavioral treatment for insomnia in service members with comorbid insomnia and prolonged postconcussive symptoms following Mild Traumatic Brain Injury mTBI The study will compare Cognitive Behavioral Therapy for Insomnia CBT-I and Brief Behavioral Therapy for Insomnia BBT-I and determine the impact of behavioral insomnia treatment on insomnia symptom severity This study will explore the impact of insomnia treatment on prolonged postconcussive symptoms and blood-based biomarkers The overall objective is to determine if behavioral insomnia therapy can improve outcomes in service members with prolonged postconcussive symptoms following mTBI
Both in-person and telehealth treatment formats will be offered to adapt to the service members schedule The minimum acceptable number of sessions to the interventions in order to have evaluable data will be 4 sessions for CBT-I and 3 sessions for BBT-I A participant is considered to have completed the study if he or she has completed the baseline assessment at least 4 sessions for CBT-I and 3 sessions for BBT-I and the 7-week and 12-week follow-up assessments
Participants will be seen and treated at the Intrepid Spirit Center andor the STRONG STAR offices both part of the Carl R Darnall Army Medical Center CRDAMC located on the Fort Cavazos Active duty service members at least 18 years of age who are seeking clinical care for persisting mTBI symptoms at the Intrepid Spirit Center located on Fort Cavazos Women will be actively recruited into the study
Both in-person and telehealth treatment formats will be offered to adapt to the service members schedule The minimum acceptable number of sessions to the interventions in order to have evaluable data will be 4 sessions for CBT-I and 3 sessions for BBT-I A participant is considered to have completed the study if he or she has completed the baseline assessment at least 4 sessions for CBT-I and 3 sessions for BBT-I and the 7-week and 12-week follow-up assessments
Participants will be seen and treated at the Intrepid Spirit Center andor the STRONG STAR offices both part of the Carl R Darnall Army Medical Center CRDAMC located on the Fort Cavazos Active duty service members at least 18 years of age who are seeking clinical care for persisting mTBI symptoms at the Intrepid Spirit Center located on Fort Cavazos Women will be actively recruited into the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None