Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

Part of paid clinical trials in Fort Cavazos, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT06551987
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy for Insomnia — BEHAVIORAL
    6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
  • Brief Behavioral Therapy for Insomnia — BEHAVIORAL
    4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.

Study Details

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).

Key Dates

Start date
Dec 3, 2024
Status verified
Dec 2025
Primary completion
Feb 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cognitive Behavioral Therapy for Insomnia
    6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
  • Active Comparator: Brief Behavioral Therapy for Insomnia
    4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.

Primary Outcome Measure

Insomnia Severity Index (ISI) [ Time Frame: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carl R. Darnall Army Medical CenterFort CavazosTexas76544
Scot D Engel, PsyD
(254) 287-7281
Kristi E Pruiksma, PhD
[email protected]
(210) 562-6700

Find similar trials in Fort Cavazos, TX

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Carl R. Darnall Army Medical Center· Fort Cavazos, TX

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