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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

Study acronym: 3D01
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Study sites: 1 to 2 · Start date changed from estimate of Jan 2026 to Mar 2, 2026 · Eligibility criteria expanded, about 8 words · 3 more Show 6 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Jan 2026 to Mar 2, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 8 words
    • Publications: details revised at 11 of 12 entries
  2. Eligibility criteria revised Study description shortened, about 17 wordsv2 Show 1 more changeShow less
    • Study description shortened, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT07060690
Lead Sponsor Francesc Colom, PsyD, PhD
Collaborators: Instituto de Salud Carlos III, Hospital del Mar
Conditions Depression Symptoms, Depression - Major Depressive Disorder, Depressive Disorder
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov