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Efficacy of a Personalized, Response-based Transdiagnostic Intervention for Emotional Disorders Delivered Via the Internet: A Protocol for an Adaptive Randomized Controlled Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion pushed from Dec 2028 to Dec 2029v4 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Start date: Oct 1, 2026 to May 1, 2027
    • Study completion pushed from Jun 2029 to Jul 2030
    • Secondary endpoints: 2 to 10
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 1 word
    • Study title expanded, about 2 words
  2. Start date: Oct 1, 2025 to Oct 1, 2026v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Universitat Jaume I
21 trials monitored
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Anxiety
3,263 trials monitored
See 159 trials at risk
Depression
3,055 trials monitored
See 173 trials at risk
This adaptive randomized controlled trial evaluates the efficacy of a transdiagnostic, internet-delivered psychological intervention for emotional disorders, tailored to patient´s early clinical response. 366 adults with clinically significant symptoms of depression and/or anxiety will begin a 12 module self-applied program. Based on sympton reduction after the first three modules, participants will be classified as early or late responders and randomized into different experimental arms. The main hypothesis is that a hybrid format (self-applied modules plus synchronous sessions with a therapist) will yield better outcomes for late responders. Outcomes include symptom reduction, emotional regulation and internet based therapheutic alliance.
Trial Details
NCT Number NCT07051148
Lead Sponsor Universitat Jaume I
Conditions
(from sponsor)		 Emotional Disorders, Anxiety, Depression, Unipolar
Related terms Anxiety Disorders, Depression, Depressive Disorder
Enrollment 366 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov