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Evaluating a Personalised Online Program With Human Support for Women With Depression and Its Impact on Mental Health and Biological Changes

RecruitingNAAges 18 Years - 45 YearsFemaleFrancesc Colom, PsyD, PhD
NCT07060690 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study aims to evaluate the efficacy of a specially developed internet-based Cognitive Behavioural Therapy (CBT) programme with human interaction-referred to as the 3D programme-tailored specifically for women experiencing moderate depressive symptoms. We hypothesise that participation in the intervention will lead to greater improvements in depression severity, compared to receiving only brief psychoeducational videos, when used as an add-on to treatment as usual (TAU) in this population. The 3D programme is a 10-week blended intervention that includes ten weekly online self-guided modules focused on depression and women's health, along with six individual video sessions with a health/clinical psychologist. The modules cover topics such as mood changes across the menstrual cycle, body image, stress, caregiving, and the impact of gender-based experiences on mental health. To explor

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📋 Eligibility rules (as published)
Inclusion Criteria: * Women * Age between 18 and 45 years (inclusive) * Moderate depressive symptoms, defined by a score of 17 to 23 on the 17-item Hamilton Depression Rating Scale (HDRS-17) * Fluent in Spanish * Access to the internet and the ability to use digital devices (e.g., smartphone, tablet, or computer) Exclusion Criteria: * Currently receiving psychological therapy * Participation in any other interventional clinical trial for depression within the past 3 months * Pregnant or planning to become pregnant during the study period * Cognitive impairment that may interfere with informed consent or study participation * Presence of psychotic symptoms, active suicidal ideation, or current substance abuse disorder
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What it tests

  • iCBT with human interaction
  • Psychoeducational videos
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Where

2 sites
Parc de Recerca Biomèdica de Barcelona
Barcelona, Spain
Hospital del Mar Research Institute
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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