A Women-Centered Approach: Evaluating a Human-Supported Online Intervention for Depression. Study on Its Efficacy and the Metabolic Signature of Personalised Treatment Response
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Depression severity
研究概览
简要总结
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.
详细描述
OBJECTIVES Primary objective: To assess the impact of the 3D programme on depressive symptom severity compared to a psychoeducational control condition.
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:
- Participation in the 3D programme will improve overall functioning in women with mild to moderate depressive episodes.
- Participation in the 3D programme will improve health-related quality of life in women with mild to moderate depressive episodes.
- Participants in the 3D programme with higher perceived stress levels will show less improvement in depression severity compared to those with lower stress levels.
- Participants in the 3D programme with higher menstruation-related distress will show greater improvement in depression severity than those with lower levels of distress.
- Participants in the 3D programme with more gynaecological problems will experience greater improvement in depression severity than those with fewer gynaecological issues.
- A metabolic signature related to tryptophan metabolism and steroid hormones will predict the response to the 3D intervention.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: iCBT with human interaction (Behavioral)
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.
干预措施: Psychoeducational videos (Behavioral)
结局指标
主要结局
Depression severity
时间窗: Baseline (T0): At enrolment/start of intervention. Post-intervention (T1): 3 months after baseline. Follow-up (T2): 6 months after baseline
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.
次要结局
- 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.)
研究者
Francesc Colom, PsyD, PhD
Principal Investigator
Hospital del Mar Research Institute (IMIM)