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.
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
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
Parallel
iCBT with human interaction
BehavioralThe 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.
Psychoeducational videos
BehavioralThis 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.
Depression severity
Change in depressive symptoms, as measured by the 17-item Hamilton Depression Rating Scale (HDRS-17), validated in Spanish. Score range: 0 to 52; higher scores indicate more severe depression.
Overall functioning
Change in overall functioning, measured using the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0, 36-item version), self-administered and validated in Spanish.The WHO-DAS 2.0 assesses functioning across six domains. Higher scores indicate greater disability. The Spanish version has demonstrated strong psychometric properties across psychiatric populations.
Health-related quality of life
Change in health-related quality of life, assessed using the EQ-5D-5L, a self-reported questionnaire validated in Spanish. The EQ-5D-5L measures five dimensions. Each dimension is rated on a 5-point scale, and responses are combined into a single index score ranging from below 0 (very poor health) to 1 (perfect health). Additionally, a Visual Analogue Scale (VAS) is included, ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Perceived Stress
Change in perceived stress, measured using the Perceived Stress Scale (PSS-10), a 10-item self-reported questionnaire validated in Spanish. Each item is rated on a 5-point scale from 0 (never) to 4 (very often). Total scores range from 0 to 40, with higher scores indicating greater levels of perceived stress.
Menstruation-related distress
Change in menstruation-related distress, measured using the Menstrual Distress Questionnaire (MEDI-Q), a 25-item self-reported tool assessing symptoms such as pain, discomfort, psychological changes, gastrointestinal issues, and physiological alterations. The MEDI-Q is a novel instrument and does not yet have a validated Spanish version; this study may contribute to its adaptation for Spanish-speaking populations.
Tryptophan metabolism biomarkers
Quantification of tryptophan and related metabolites (kynurenine, serotonin, 3-hydroxykynurenine, 5-hydroxyindoleacetic acid, kynurenic acid) and calculation of metabolic ratios (e.g., kynurenine/tryptophan ratio) using LC-MS/MS in biological samples (blood, saliva, urine, nails, hair). Higher or altered levels may be associated with treatment response.
Steroid hormone profile
Changes in hormone production and balance over time associated with intervention participation. Measurement of sex hormones (estradiol, testosterone, progesterone) and glucocorticoids (cortisol, 20α-DHE, 20β-DHE) and their metabolites using LC-MS/MS in biological samples (blood, saliva, urine, nails, hair). Hormonal alterations over time will be evaluated as potential markers of treatment effects.
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Francesc Colom, PsyD, PhD
Lead sponsor
Hospital del Mar Research Institute (IMIM)
Sponsor institution
Instituto de Salud Carlos III
Collaborator
Hospital del Mar
Collaborator
