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NCT06332209

Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved 2 years later.

See at-risk trials from Medical University of South Carolina

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Record History

All 10 versions: 9 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 30, 2026 to Sep 30, 2028
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Sep 30, 2025 to Sep 30, 2026
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2025 to Apr 1, 2025
    v8
  3. Start date: Feb 2, 2025 to Apr 2025v7
  4. Start date: Dec 2, 2024 to Feb 2, 2025v6
  5. Start date: Oct 1, 2024 to Dec 2, 2024v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Aug 1, 2024 to Oct 1, 2024v4
  2. Start date: Jun 1, 2024 to Aug 1, 2024v3
  3. Secondary endpoints: details revised at 2 of 2 entriesv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Traumatic Stress Symptoms
Timeframe: baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)

Secondary (1)

Anxiety and Depression Symptoms

Arms and interventions

Tele-TF-CBTActive comparator

Trauma-Focused Cognitive Behavioral Therapy delivered via telehealth

Clinic-TF-CBTActive comparator

Trauma-Focused Cognitive Behavioral Therapy delivered in clinic (in-person)

Behavioral: Trauma Focused Cognitive Behavioral Therapy

Sites

1 site in 1 country

  • Medical University of South CarolinaCharleston, South Carolina, United States