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Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

NCT06551987 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-01-07

No results posted yet for this study

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).

Conditions

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.

BEHAVIORAL

Brief Behavioral Therapy for Insomnia

4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Hope Health Research Institute

    collaborator UNKNOWN

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Kristi E Pruiksma, PhD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-03
Primary Completion
2027-02-01
Completion
2027-09-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06551987 on ClinicalTrials.gov