Evaluating a Personalised Online Program With Human Support for Women With Depression and Its Impact on Mental Health and Biological Changes
NCT ID: NCT07060690
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2026-01-31
2027-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression
NCT00841737
Bounce-Back From Depression
NCT06832605
Efficacy of an Online Program for the Treatment of Mild and Moderate Depression
NCT02312583
Effectiveness of a Psychoeducational Group Intervention in Patients With Depression and Physical Comorbidity
NCT03243799
Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
NCT01542957
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Secondary objectives: To evaluate improvements in overall functioning, quality of life, perceived stress, and menstruation-related distress. Additionally, the study will investigate metabolic signatures associated with treatment response, focusing on tryptophan and steroid hormone pathways.
HYPOTESES Main hypothesis: Participation in the 3D programme will lead to greater improvements in depression severity (measured by HDRS-17) compared to receiving only informational materials when used as an add-on to Treatment As Usual (TAU) in women experiencing mild to moderate depressive episodes.
Secondary hypotheses:
1. Participation in the 3D programme will improve overall functioning in women with mild to moderate depressive episodes.
2. Participation in the 3D programme will improve health-related quality of life in women with mild to moderate depressive episodes.
3. Participants in the 3D programme with higher perceived stress levels will show less improvement in depression severity compared to those with lower stress levels.
4. Participants in the 3D programme with higher menstruation-related distress will show greater improvement in depression severity than those with lower levels of distress.
5. Participants in the 3D programme with more gynaecological problems will experience greater improvement in depression severity than those with fewer gynaecological issues.
6. A metabolic signature related to tryptophan metabolism and steroid hormones will predict the response to the 3D intervention.
7. Participation in the 3D programme will lead to changes in hormone production and/or balance, with the persistence of these hormonal changes correlating with the long-term effects of the intervention.
SAMPLE SIZE ESTIMATION AND RECRUITMENT The optimal sample size is estimated to be 60 participants per group. This calculation is based on a Cohen's d effect size of 0.2, a 95% confidence interval, a statistical power of 90%, and an anticipated attrition rate of 20%. Sample size estimation was conducted using G\* Power 3.1.7 software.
All patients meeting the inclusion and exclusion criteria will be invited to participate in the study by their treating team at the outpatient mental health facilities within Hospital del Mar. Additionally, gynaecologists at Hospital del Mar will be encouraged to refer patients suspected of experiencing depressive symptoms. In such cases, patients will be screened by the study psychologist/psychiatrist to confirm these symptoms. Recruitment will conclude upon reaching the target of 120 participants with complete data.
RANDOMISATION AND BLINDING Participants will be randomised in a 1:1 ratio using the REDCap randomisation module, which will automatically assign participants to either the experimental or control group through simple randomisation with equal allocation.
This study will implement single blinding. Due to the nature of the intervention, participants will be aware of their group assignment (experimental or control) following randomisation. Likewise, therapists delivering the intervention will be aware of the assigned group, as is standard practice in psychological intervention trials. To uphold the integrity of the blinding process, the following measures will be applied:
1. Personnel responsible for data analysis will remain blinded to group assignments.
2. Independent raters conducting outcome assessments will be blinded to participant group allocation.
3. Other stakeholders, including clinicians, statisticians, and the principal investigator, will remain unaware of the randomisation process and group assignments to minimise potential bias.
STUDY DESING Part 1. Randomised controlled trial The study follows a naturalistic treatment approach, ensuring that all participants continue their usual care. The study will be conducted in accordance with the CONSORT guidelines.
PART 2. Metabolic signature of treatment response The metabolic signature of treatment response will be characterised through the analysis of tryptophan and steroid-related pathways. All analyses will be conducted using methods developed and validated by the Applied Metabolomic Research Group at Hospital del Mar Research Institute, ensuring proper sample handling protocols as outlined in previous studies.
Tryptophan Metabolism:
Tryptophan pathway metabolites-including tryptophan, kynurenine, serotonin, 3-hydroxykynurenine, 5-hydroxyindoleacetic acid, and kynurenic acid-will be quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The analysis will follow the protocol established by Marcos et al.
Analysis will focus on the kynurenine/tryptophan (K/T) ratio, a marker of indoleamine-2,3-dioxygenase (IDO) activity, which plays a key role in immune regulation and inflammatory responses.
Additionally, serotonin synthesis and its relationship with tryptophan availability will be assessed, alongside the tryptophan/large neutral amino acid (LNAA) ratio, which serves as an indicator of tryptophan's availability for serotonin production. Data will be integrated using network analysis to identify potential associations between these metabolites and treatment response.
Steroid Hormones:
The steroid profile will be analysed to monitor key sex hormones (e.g., estradiol, testosterone, progesterone) and glucocorticoids (e.g., cortisol, 20α-DHE, and 20β-DHE), along with their metabolites. These hormones play a pivotal role in modulating inflammation and metabolic pathways, with altered levels linked to physiological stress responses and treatment outcomes. These measurements will be performed by LC-MS/MS, following the method previously outlined by the research group.
Biological Samples:
Analysis will be conducted using various biological matrices, including blood, saliva, urine, nails, and hair, to provide complementary insights. Saliva, blood, and urine samples will capture acute metabolic changes at the time of the visit, while nails and hair will reflect chronic metabolite production.
ASSESSMENTS Assessments will be carried out at baseline (T0), immediately following the intervention (3 months after baseline, T1), and at a follow-up assessment (6 months after baseline, T2).
The baseline assessment will include:
* Collection of socio-demographic and clinical data, with self-reported information gathered via a secure, online-based assessment system (REDCap).
* Collection of biological samples (blood, saliva, urine, nails, and hair), with sample collection times recorded to account for circadian-sensitive metabolites. These samples will be collected exclusively from cisgender women.
* A gynaecology consultation to assess hormonal and menstrual complications. These will be evaluated using a 5-point Likert scale, ranging from "1 - No complication" to "5 - Severe complication requiring significant gynaecological intervention or further medical examination." Patients who require additional medical evaluations will be referred for appropriate follow-up care.
* Metabolic analysis, focusing on tryptophan metabolism and steroid hormone regulation, with the goal of identifying biomarkers predictive of therapeutic outcomes.
Clinical data and biological samples will be collected at all time points.
DATA MANAGEMENT All the data will be text-based (.docx) or numeric format (.xlsx). For all published files, a document record and change track will be included (author contact information, status, version, change reason and date, contents" description, title, origin of the data including a description of the measurement and/or experiment setup) in a separate metadata file for each characterization action called METADATA.ODS.
Data will be stored on a secure server at the Hospital del Mar Research Institute, in compliance with EU and Spanish data protection regulations (General Data Protection Regulation, GDPR, of May 25, 2018; and Organic Law 3/2018 of December 5, on the Protection of Personal Data and Guarantee of Digital Rights).
STATISTICAL ANALYSIS
Primary and Secondary Outcomes:
Analyses will follow an intention-to-treat (ITT) approach, including all participants according to their randomized allocation, regardless of adherence to the intervention.group. Linear mixed-effects models (LMMs) will be used to examine changes over time and between groups for the HDRS-17, WHO-DAS 2.0, EQ-5D-5L, PSS, and MEDI-Q scores. These models will include fixed effects for group, time, and their interaction, and a random intercept for participants to account for within-subject correlation over time. Where appropriate, subscale-level analyses and models using change scores will also be conducted for secondary outcomes. To further explore the temporal dynamics of the intervention's effects, post hoc simple effects analyses will be performed to probe significant interactions.
Additional Analyses:
LLMs and multiple linear regression models will be employed to identify predictors of clinical improvement. Additionally, moderator analyses using linear mixed models will assess whether levels of perceived stress (PSS), or menstrual distress (MEDI-Q) influence treatment response as measured by changes in HDRS-17 scores over time.
Exploratory Biomarker Analyses:
Partial Least Squares Regression (PLSR) and multiple regression will be conducted to model associations between metabolite profiles, their changes over time, and changes in depressive symptoms. Variable Importance in Projection (VIP) scores and cross-validation techniques will be applied to evaluate model performance and identify key predictive biomarkers. Additionally, metabolomic evolution will be assessed through exploratory factor analysis, grouping variables into latent factors.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Internet-based Cognitive Behavioural Therapy (iCBT) with human interaction+ Treatment as usual (TAU)
Participants will undertake the 3D programme, a 10-week internet-delivered cognitive behavioural therapy (iCBT) intervention tailored for women.
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.
Brief psychoeducational videos + TAU
Participants will continue to receive their usual treatment for depression from their healthcare team throughout the study. Additionally, over 10 weeks, they will receive biweekly emails containing links to six brief educational video capsules covering depression causes, behavioural activation, hormonal cycle effects, sleep strategies, healthy habits, and relapse prevention.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age between 18 and 45 years (inclusive)
* Mild to 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Instituto de Salud Carlos III
OTHER_GOV
Hospital del Mar
OTHER
Francesc Colom, PsyD, PhD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francesc Colom, PsyD, PhD
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital del Mar Research Institute
Barcelona, Catalonia, Spain
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Vannuccini S, Rossi E, Cassioli E, Cirone D, Castellini G, Ricca V, Petraglia F. Menstrual Distress Questionnaire (MEDI-Q): a new tool to assess menstruation-related distress. Reprod Biomed Online. 2021 Dec;43(6):1107-1116. doi: 10.1016/j.rbmo.2021.08.029. Epub 2021 Oct 26.
Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.
Vazquez-Barquero JL, Vazquez Bourgon E, Herrera Castanedo S, Saiz J, Uriarte M, Morales F, Gaite L, Herran A, Ustun TB. [Spanish version of the new World Health Organization Disability Assessment Schedule II (WHO-DAS-II): initial phase of development and pilot study. Cantabria disability work group]. Actas Esp Psiquiatr. 2000 Mar-Apr;28(2):77-87. Spanish.
Hernandez G, Garin O, Pardo Y, Vilagut G, Pont A, Suarez M, Neira M, Rajmil L, Gorostiza I, Ramallo-Farina Y, Cabases J, Alonso J, Ferrer M. Validity of the EQ-5D-5L and reference norms for the Spanish population. Qual Life Res. 2018 Sep;27(9):2337-2348. doi: 10.1007/s11136-018-1877-5. Epub 2018 May 16.
Ramos-Brieva JA, Cordero-Villafafila A. A new validation of the Hamilton Rating Scale for Depression. J Psychiatr Res. 1988;22(1):21-8. doi: 10.1016/0022-3956(88)90024-6.
Zimmerman M, Martinez JH, Young D, Chelminski I, Dalrymple K. Severity classification on the Hamilton Depression Rating Scale. J Affect Disord. 2013 Sep 5;150(2):384-8. doi: 10.1016/j.jad.2013.04.028. Epub 2013 Jun 4.
Krieger T, Bur OT, Weber L, Wolf M, Berger T, Watzke B, Munder T. Human contact in internet-based interventions for depression: A pre-registered replication and meta-analysis of randomized trials. Internet Interv. 2023 Mar 31;32:100617. doi: 10.1016/j.invent.2023.100617. eCollection 2023 Apr.
Marx W, McGuinness AJ, Rocks T, Ruusunen A, Cleminson J, Walker AJ, Gomes-da-Costa S, Lane M, Sanches M, Diaz AP, Tseng PT, Lin PY, Berk M, Clarke G, O'Neil A, Jacka F, Stubbs B, Carvalho AF, Quevedo J, Soares JC, Fernandes BS. The kynurenine pathway in major depressive disorder, bipolar disorder, and schizophrenia: a meta-analysis of 101 studies. Mol Psychiatry. 2021 Aug;26(8):4158-4178. doi: 10.1038/s41380-020-00951-9. Epub 2020 Nov 23.
Montcusi B, Madrid-Gambin F, Pozo OJ, Marco S, Marin S, Mayol X, Pascual M, Alonso S, Salvans S, Jimenez-Toscano M, Cascante M, Pera M. Circulating metabolic markers after surgery identify patients at risk for severe postoperative complications: a prospective cohort study in colorectal cancer. Int J Surg. 2024 Mar 1;110(3):1493-1501. doi: 10.1097/JS9.0000000000000965.
Marcos J, Renau N, Valverde O, Aznar-Lain G, Gracia-Rubio I, Gonzalez-Sepulveda M, Perez-Jurado LA, Ventura R, Segura J, Pozo OJ. Targeting tryptophan and tyrosine metabolism by liquid chromatography tandem mass spectrometry. J Chromatogr A. 2016 Feb 19;1434:91-101. doi: 10.1016/j.chroma.2016.01.023. Epub 2016 Jan 14.
Marcos J, Renau N, Casals G, Segura J, Ventura R, Pozo OJ. Investigation of endogenous corticosteroids profiles in human urine based on liquid chromatography tandem mass spectrometry. Anal Chim Acta. 2014 Feb 17;812:92-104. doi: 10.1016/j.aca.2013.12.030. Epub 2014 Jan 3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023/11236/I
Identifier Type: OTHER
Identifier Source: secondary_id
PI23/00257
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.