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

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 mild to 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.

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	2026-01
Primary Completion	2027-08 (estimated)
Study Completion	2027-08 (estimated)
Updated on ClinicalTrials.gov	2025-07-16