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

NANot yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 31, 2026

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
Depression SymptomsDepression - Major Depressive DisorderDepressive Disorder
Interventions
BEHAVIORAL

iCBT with human interaction

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.

BEHAVIORAL

Psychoeducational videos

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.

Trial Locations (1)

08003

Hospital del Mar Research Institute, Barcelona

All Listed Sponsors
collaborator

Instituto de Salud Carlos III

OTHER_GOV

collaborator

Hospital del Mar

OTHER

lead

Francesc Colom, PsyD, PhD

OTHER

NCT07060690 - Evaluating a Personalised Online Program With Human Support for Women With Depression and Its Impact on Mental Health and Biological Changes | Biotech Hunter | Biotech Hunter