NCT07060690Recruiting
Evaluating a Personalised Online Program With Human Support for Women With Depression and Its Impact on Mental Health and Biological Changes
A Women-Centered Approach: Evaluating a Human-Supported Online Intervention for Depression. Study on Its Efficacy and the Metabolic Signature of Personalised Treatment Response
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 2 Jul 2025
- Start date
- 2 Mar 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Francesc Colom, PsyD, PhD
- Diseases
- Depression
- NCT number
- NCT07060690
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 2 Mar 2026 to the primary completion date, 31 Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving psychological therapy
Other illness
- Cognitive impairment that may interfere with informed consent or study participation
- Presence of psychotic symptoms, active suicidal ideation, or current substance abuse disorder
Other
- Participation in any other interventional clinical trial for depression within the past 3 months
- Pregnant or planning to become pregnant during the study period
Who the study is looking for
- 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)
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital del Mar Research Institute Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Parc de Recerca Biomèdica de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.