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

Summary

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.

Conditions

• Depression Symptoms
• Depression - Major Depressive Disorder
• Depressive 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.

Sponsors & Collaborators

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Hospital del Mar

  collaborator OTHER

• Francesc Colom, PsyD, PhD

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-31

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• Spain

Study Locations