Personalized online program with human support for women with depression
Official title: A Women-Centered Approach: Evaluating a Human-Supported Online Intervention for Depression. Study on Its Efficacy and the Metabolic Signature of Personalised Treatment Response
Run by Hospital del Mar Research Institute (IMIM) · NCT07060690 · Data updated 2026-11-12
A 3D 10-week online CBT program with weekly modules and six coaching sessions is tested as an add-on to usual care to see if it reduces depressive symptoms in women aged 18–45 with moderate depression.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Hospital del Mar Research Institute (IMIM) Academic / other |
| Locations | 2 sites (Barcelona, Barcelona and 1 other locations) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07060690 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–45 with moderate depressive symptoms (HDRS-17 17–23), fluent in Spanish, with internet access and the ability to engage in online and video-based sessions.
✕Probably not a fit
Those not benefiting may include individuals with more severe depression, those not responsive to CBT, or participants with ongoing psychotherapy or contraindicating conditions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial tests a blended, internet-based CBT program tailored for women experiencing moderate depressive symptoms, delivered with human coaching alongside standard care. Participants complete ten online modules and six video sessions with a psychologist over 10 weeks. The study compares the 3D program to brief psychoeducational videos on depressive outcomes, functioning, quality of life, stress, and menstruation-related distress, while also exploring biological markers tied to treatment response. Primary outcome focuses on changes in depression severity (HDRS-17); secondary outcomes include functioning, quality of life, perceived stress, and metabolic pathways related to tryptophan and steroid hormones.
Why it matters
Potential benefit: If successful, participants could experience greater reductions in depressive symptoms and improvements in daily functioning and quality of life.
How similar studies have gone: Previous internet-based CBT approaches with some human support have shown benefits in depression, though this study adds a gender- and biology-informed angle with metabolic analyses.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Currently receiving psychological therapy * Participation in any other interventional clinical trial for depression within the past 3 months * Pregnant or planning to become pregnant during the study period * Cognitive impairment that may interfere with informed consent or study participation * Presence of psychotic symptoms, active suicidal ideation, or current substance abuse disorder
Where it's running
-
Parc de Recerca Biomèdica de Barcelona
Barcelona, Barcelona, Spain Recruiting -
Hospital del Mar Research Institute
Barcelona, Catalonia, Spain Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.