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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Francesc Colom, PsyD, PhD • ClinicalTrials.gov ID: NCT07060690

Registry updated: 2026-10-09
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Description

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 explore how biological factors may influence how participants respond to treatment, the study will collect biological samples. These will be analysed to track hormone and metabolic changes, with the goal of identifying biological markers that might predict who benefits most from the intervention. Ultimately, the results of this study aim to improve access to effective and personalised mental health care for women by evaluating whether a structured and personalised online CBT programme can provide meaningful benefits.

Interventions

  • iCBT with human interaction (Behavioral)
    The 3D programme is a 10-week online intervention based on Cognitive Behavioural Therapy (CBT), designed to support women's mental health. Participants will use the 3D website to complete 10 weekly self-guided modules that include videos, written materials, and interactive activities. Topics address depression and issues commonly experienced by women, such as hormonal changes, caregiving, body image, and sexism. All content is available in both video and text formats. Participants will also have six one-to-one video sessions with a trained health/clinical psychologist, who will tailor the programme by recommending specific modules or tasks. All therapists will complete training on the 3D programme and online therapy. Participants will receive guidance on how to use the 3D website before starting.
  • Psychoeducational videos (Behavioral)
    This control arm provides psychoeducational content without therapist support or homework assignments, serving as an adjunct to standard care. This distinguishes it from the experimental arm, which includes therapist-guided interventions and active homework components.

Eligibility criteria

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

Conditions

Depression Symptoms Depression - Major Depressive Disorder Depressive Disorder

Locations

  • Parc de Recerca Biomèdica de Barcelona — Barcelona, Barcelona, Spain
  • Hospital del Mar Research Institute — Barcelona, Catalonia, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record