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Efficacy of a Transdiagnostic Group Treatment for Emotional Disorders Applied in Blended Format: a Controlled Study.

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jul 2025 to Jul 2027
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2024 to Nov 23, 2024
    v6
  2. Notable Start date: Jul 2024 to Sep 2024v5 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Primary and study completion dates: Jun 2025 to Jul 2025
    • Secondary endpoints: 5 to 8
    • Publications: 26 to 32
  3. Notable Start date: Oct 2023 to Jul 2024v4
  4. Notable Primary and study completion dates: Nov 2024 to Jun 2025
    • Start date: Feb 2023 to Oct 2023
    • Secondary endpoints: details revised at 5 of 5 entries
    v3
  5. Minor Enrollment target: 159 to 144
    • Study description expanded, about 2 words
    v2
  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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This study will consist in a randomized controlled clinical trial (RCT) to test the efficacy of a blended group transversal protocol (BLGr-TP) compared to a face-to-face group transversal protocol (FFGr-TP). The main aims of the study are the following: * To analyze the differential efficacy of the BLGr-TP versus the FFGr-TP for the treatment of emotional disorders in aspects of clinical measures, as well as in terms of retention and dropout rate and adherence. * To analyze the differential acceptability of the BLGr-TP versus the FFGr-TP for the treatment of emotional disorders. In addition, it is intended to carry out a study of mediators and moderators of the efficacy of both interventions. The established hypotheses in relation to the main goals are: * Both treatment modalities (FFGr-TP and BLGr-TP) will achieve improvements in the symptoms of emotional disorders, reflected in the scores of the clinical measures. * The BLGr-TP will show equivalent efficacy to the FFGr-TP. * The BLGr-TP will show an acceptability comparable to the face-to-face protocol. Both modalities will be well valued by the participants. * In both treatment modalities, the changes achieved are expected to be maintained over time (3, 6 and 12 months).
Trial Details
NCT Number NCT05569018
Lead Sponsor Universitat Jaume I
Conditions
(from sponsor)
Anxiety Disorders, Depressive Disorders
Related terms Anxiety Disorders, Depressive Disorder
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov