Personalised Online Cognitive Behavioural Therapy With Human Support for Women With Moderate Depression and Its Biological Impact
Led by Francesc Colom, PsyD, PhD · Updated on 2026-10-09
120
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What This Trial Is About
Researchers are evaluating a specially developed internet-based Cognitive Behavioural Therapy CBT program called the 3D programme, designed specifically for women with moderate depressive symptoms. The study aims to compare the effects of this blended intervention with brief psychoeducational videos when added to usual treatment. It also investigates how biological factors like hormone and metabolic changes may influence treatment response, seeking to identify markers that predict who benefits most.
The 3D programme lasts 10 weeks and includes ten weekly online self-guided modules about depression and womens health topics such as menstrual mood changes, body image, and stress. Participants also have six individual video sessions with a clinical psychologist who personalizes the therapy. The comparison group receives usual care plus biweekly brief educational videos on depression causes and coping strategies.
Participants will be involved in assessments at the start, immediately after the intervention 3 months, and at follow-up 6 months. These include clinical evaluations, questionnaires, and collection of biological samples like blood, saliva, urine, nails, and hair to analyze hormonal and metabolic markers. The research team will measure depression severity and other outcomes such as overall functioning, quality of life, stress, and menstruation-related distress while monitoring these biological changes to understand their relationship with treatment effects.
CONDITIONS
Brief Title
Evaluating a Personalised Online Program With Human Support for Women With Depression and Its Impact on Mental Health and Biological Changes
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Moderate depressive symptoms defined by a score of 17 to 23 on the 17-item Hamilton Depression Rating Scale
Fluent in Spanish
Access to the internet and ability to use digital devices such as a smartphone, tablet, or computer
You will not qualify if you...
Currently receiving psychological therapy
Participation in another interventional clinical trial for depression within the past 3 months
Pregnant or planning to become pregnant during the study period
Cognitive impairment interfering with informed consent or study participation
Presence of psychotic symptoms, active suicidal thoughts, or current substance abuse disorder
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 10 weeks
Participants receive either the 10-week 3D online Cognitive Behavioural Therapy program with psychologist support or biweekly brief psychoeducational videos, along with their usual depression care.
Weekly online modules and six video sessions for the 3D group; biweekly video links for the control group
Follow-up
Duration - Up to 6 months
Participants undergo assessments including clinical evaluations and biological sample collection at 3 months and 6 months after starting the study to monitor outcomes and biological changes.
Assessments at 3 and 6 months after baseline
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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