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Studies

Interventional Recruiting

NCT06230237 on ClinicalTrials.gov

Telephone Support vs. Self-guidance in an Internet-based Self-administered Psychological Program to Address Depression

Official title: Telephone Support vs. Self-guidance in an Internet-based Self-administered Psychological Program for the Treatment of Depression

  • Sponsor: Jaume I University
  • Collaborators: Hospital Francesc de Borja
  • Enrollment: 100 (Estimated)
  • Study start: 2022-06-01 (Actual)
  • Primary completion: 2024-06-01 (Estimated)
  • Study completion: 2024-12-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

Depression is a first level problem that poses a challenge for Primary Care (PC). The overload of care in this area requires lower-cost and more accessible alternatives. Internet-based self-applied cognitive behavioral treatments (CBCT) have demonstrated their efficacy and added advantages. The "Smiling is fun" program has been validated in Spanish PC and has demonstrated its usefulness and cost-effectiveness. Previous studies have shown that professional support or guidance increases the results of the TCCI.

The aim of the present study is to contrast, by means of a randomized controlled trial, aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support.

Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services.

Conditions

  • Depression

Intervention / Treatment

  • Behavioral: Smiling is fun + professional support
  • Behavioral: Smiling is fun

Primary Outcome Measures

  • Treatment efficacy (Pre-intervention, immediately after the intervention and follow-up (3,6 and 12 months).)
    Change of depression symtpmatology through the Beck Depression Inventory (BDI-II).

Countries

Spain

Locations and Investigators

  • Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja, Tavernes de la Valldigna, Spain (Recruiting)
    • Rosa Lorente Català

Study Officials

  • Azucena García Palacios (Study Chair) — Universidad Jaume I
  • Pedro Vera Albero (Study Director) — F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja
  • Raquel Escriva Sanchis (Study Chair) — F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja
  • Clara Bretó García (Study Chair) — F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja