Evaluating a Personalised Online Program With Human Support for Women With Depression and Its Impact on Mental Health and Biological Changes

NCT07060690 | Not Yet Recruiting

• 2 other identifiers: PI23/002572023/11236/I
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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 mild to 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.

Conditions

Depression Symptoms; Depression - Major Depressive Disorder; Depressive Disorder

Keywords

Women; Metabolomics; Depression; Internet-Based Intervention; Personalized Medicine

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (T0): At enrolment/start of intervention. Post-intervention (T1): 3 months after baseline. Follow-up (T2): 6 months after baseline

Secondary Outcomes (4)

• Overall functioning

  Baseline (T0): At enrolment/start of intervention. Post-intervention (T1): 3 months after baseline. Follow-up (T2): 6 months after baseline

• Health-related quality of life

  Baseline (T0): At enrolment/start of intervention. Post-intervention (T1): 3 months after baseline. Follow-up (T2): 6 months after baseline.

• Perceived Stress

  Baseline (T0): At enrolment/start of intervention. Post-intervention (T1): 3 months after baseline. Follow-up (T2): 6 months after baseline.

• Menstruation-related distress

  Baseline (T0): At enrolment/start of intervention. Post-intervention (T1): 3 months after baseline. Follow-up (T2): 6 months after baseline.

Other Outcomes (2)

• Tryptophan metabolism biomarkers

  Baseline (T0): At enrolment/start of intervention. Post-intervention (T1): 3 months after baseline. Follow-up (T2): 6 months after baseline.

• Steroid hormone profile

  Baseline (T0): At enrolment/start of intervention. Post-intervention (T1): 3 months after baseline. Follow-up (T2): 6 months after baseline.

Study Arms (2)

Internet-based Cognitive Behavioural Therapy (iCBT) with human interaction+ Treatment as usual (TAU)

EXPERIMENTAL

Participants will undertake the 3D programme, a 10-week internet-delivered cognitive behavioural therapy (iCBT) intervention tailored for women.

Behavioral: iCBT with human interaction

Brief psychoeducational videos + TAU

ACTIVE COMPARATOR

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.

Behavioral: Psychoeducational videos

Interventions

iCBT with human interaction BEHAVIORAL

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.

Also known as: 3D

Internet-based Cognitive Behavioural Therapy (iCBT) with human interaction+ Treatment as usual (TAU)

Psychoeducational videos BEHAVIORAL

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.

Brief psychoeducational videos + TAU

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Francesc Colom, PsyD, PhD: lead
• Instituto de Salud Carlos III: collaborator
• Hospital del Mar: collaborator

Study Sites (1)

Hospital del Mar Research Institute

Barcelona, Catalonia, 08003, Spain

Location

Related Publications (11)

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  PMID: 23759278 BACKGROUND

• 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.

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• 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.

  PMID: 33230205 BACKGROUND

• 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.

  PMID: 38116682 BACKGROUND

• 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.

  PMID: 26818237 BACKGROUND

• 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.

  PMID: 24491769 BACKGROUND

MeSH Terms

Conditions

Depression; Depressive Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Other key personnel, including clinicians, statisticians, lab technicians in the Metabolomics Unit, and the principal investigator, will remain blind to the randomisation procedure and group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

ES (1)