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RESTNCT07196332

Recovering Sleep After Trauma

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from University of North Carolina, Chapel Hill

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 2026 to Sep 2027
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 3 of 3 entries
  2. Recruitment opened
    • Start date changed from estimate of Apr 1, 2026 to Apr 30, 2026
    • Site details revised
    v4
  3. Start date: Jan 2026 to Apr 1, 2026
    • Site contact updated
    v3
  4. Start date: Oct 2025 to Jan 2026v2
  5. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Changes in PTSD Symptom Severity Over Time
Timeframe: Baseline, Week 4, Week 8, Month 3
Recruitment Rates
Timeframe: Baseline
Retention Rates
Timeframe: Month 3
Treatment Completion Rates
Timeframe: Week 4

Secondary (3)

Change in Depressive Symptom Score Over Time
Change in Somatic Score Symptoms Over Time
Change in Pain Symptom Severity and Extent Over Time

Arms and interventions

Brief Behavioral Treatment for Insomnia (BBTI)Experimental

Four sessions of telehealth-delivered brief behavioral treatment for insomnia

Progressive Muscle Relaxation Training (PMRT)Active comparator

Four sessions of telehealth-delivered progressive muscle relaxation training

Behavioral: Brief Behavioral Treatment for Insomnia (BBTI), Progressive Muscle Relaxation Training (PMRT)

Sites

1 site in 1 country

  • University of North Carolina at Chapel HillChapel Hill, North Carolina, United States