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Recovering Sleep After Trauma

NCT07196332 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-04

No results posted yet for this study

Summary

The main objective of this pilot trial is to assess the feasibility and preliminary efficacy of telehealth-delivered behavioral therapy to reduce the development of posttraumatic stress and depressive symptoms following motor vehicle collision among individuals at high risk. This pilot trial will provide the data necessary to design and support a large-scale trial.

Conditions

  • Post-traumatic Stress Disorder

Interventions

BEHAVIORAL

Brief Behavioral Treatment for Insomnia (BBTI)

In the first week, treatment consists of a 60-minute video individual intervention session; in the second week, participants receive a 30-minute phone call; in the third week, treatment consists of a 45-minute video individual session; the final session consists of a 30-minute phone call. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of homeostatic and circadian mechanisms of human sleep regulation. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.

BEHAVIORAL

Progressive Muscle Relaxation Training (PMRT)

In the first week, treatment consists of a 60-minute video individual intervention session; in the second week, participants receive a 30-minute phone call; in the third week, treatment consists of a 45-minute video individual session; the final session consists of a 30-minute phone call. Treatment begins with learning how to alternately tense and relax 14 major muscle groups, and then to use progressively more efficient tensing-relaxing and passive relaxation exercises, with sessions used to teach techniques and problem-solve barriers to its daily use.

Sponsors & Collaborators

  • Heart and Armor Foundation

    collaborator UNKNOWN

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Samuel McLean, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

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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 NCT07196332 on ClinicalTrials.gov