Recovering Sleep After Trauma

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07196332
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Brief Behavioral Treatment for Insomnia (BBTI) — BEHAVIORAL
    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.
  • Progressive Muscle Relaxation Training (PMRT) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Brief Behavioral Treatment for Insomnia (BBTI)
    Four sessions of telehealth-delivered brief behavioral treatment for insomnia
  • Active Comparator: Progressive Muscle Relaxation Training (PMRT)
    Four sessions of telehealth-delivered progressive muscle relaxation training

Primary Outcome Measure

Changes in PTSD Symptom Severity Over Time [ Time Frame: Baseline, Week 4, Week 8, Month 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27516
Andrea A Massa, PhD
[email protected]
919-966-1644
Jenni Shafer, PhD
[email protected]
(919) 966-1644

Find similar trials in Chapel Hill, NC

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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