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临床试验/NCT07082296
NCT07082296已完成不适用

Use of an Internet-Based Cognitive Behavioral Therapy Platform to Carry Out an Intervention Aimed at Promoting Emotional Well-Being in the University and Research Community

Joaquim Radua1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年7月11日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Retention/compliance rates

研究概览

简要总结

This study will evaluate a brief internet-based cognitive behavioral therapy (iCBT) program developed specifically for university students, researchers, and academic staff.

People in academic settings often face high levels of pressure and may experience psychological difficulties such as anxiety or excessive worry. However, access to psychological support adapted to the academic context is frequently limited.

This study investigates whether a short, self-guided online iCBT program can help promote emotional well-being in this population. The program is based on cognitive behavioral therapy principles and is designed to be completed in four weeks, with brief sessions four times per week that can be accessed on any device.

Participants will complete questionnaires before and after the intervention to assess the feasibility, acceptability, and safety of the program, as well as changes in emotional well-being.

The aim is to evaluate whether this digital intervention can serve as a useful, scalable tool to support emotional well-being in university and research environments.

详细描述

This study aims to evaluate the feasibility, acceptability, and potential effects of a brief, self-guided internet-based cognitive behavioral therapy (iCBT) program-iCBT-Academia-designed specifically for the university and research community. The intervention consists of four weekly modules delivered through a digital platform, with each module including short CBT-based lessons and practical exercises tailored to the academic context.

The study will use a single-group open-label design. Based on ICBT's previous open trials (see, for example, trials NCT03457714 or NCT03946098), 25 participants should be sufficient to estimate feasibility and preliminary effects. Participants will complete self-report questionnaires assessing various aspects of emotional well-being (positive and negative affect, life satisfaction, anxiety, and depression) before and after the intervention, as well as acceptability (TAAS) and potential adverse effects (NEQ) after the intervention. Retention, compliance, and participant feedback will also be evaluated.

This project seeks to explore whether such a digital intervention is a viable and scalable tool to support emotional well-being in academic environments.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years.
  • Ability to read in Catalan or Spanish.
  • Undergraduate or master's student, PhD student, or teaching and researching staff.

排除标准

  • (for the primary analysis):
  • Report that they are receiving psychological treatment or have a current mental disorder diagnosis.
  • High subjective well-being and minimal symptoms of anxiety and depression at baseline, defined as scoring ≥20 on the Positive Affect subscale and <10 on the Negative Affect subscale of the International Positive and Negative Affect Schedule - Short Form (I-PANAS-SF), scoring ≥26 on the Satisfaction With Life Scale (SWLS), and scoring <5 on both the Generalized Anxiety Disorder 7-item scale (GAD-7) and the Patient Health Questionnaire-9 (PHQ-9).

研究组 & 干预措施

University and Research Community

Experimental

Participants will receive the self-guided 4-week iCBT intervention.

干预措施: iCBT-Academia (Behavioral)

结局指标

主要结局

Retention/compliance rates

时间窗: Post-intervention (4 weeks after commencing treatment)

Retention/compliance rates refer to the proportion of participants who complete the study and follow the intervention as intended.

Acceptability

时间窗: Post-intervention (4 weeks after commencing treatment)

Acceptability will be measured using the Treatment Acceptability and Adherence Scale (TAAS), a brief self-report questionnaire that evaluates the acceptability of the psychological intervention from the participant's perspective. The TAAS consists of 10 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). To maintain comparability with the original scale, total scores (ranging from 10 to 50) will be linearly rescaled to range from 10 to 70. Higher scores indicate greater acceptability and adherence.

次要结局

  • Possible negative effects(Post-intervention (4 weeks after commencing treatment). In addition, the 5-item version will be administered at 1, 2, and 3 weeks after commencing treatment.)
  • Changes in affect(Pre-intervention and post-intervention (4 weeks after commencing treatment). In addition, the 4-item version will be administered at 1, 2, and 3 weeks after commencing treatment.)
  • Changes in depressive symptoms(Pre-intervention and post-intervention (4 weeks after commencing treatment). In addition, PHQ-2 will be administered at 1, 2, and 3 weeks after commencing treatment.)
  • Changes in life satisfaction(Pre-intervention and post-intervention (4 weeks after commencing treatment). In addition, the 2-item version will be administered at 1, 2, and 3 weeks after commencing treatment.)
  • Changes in anxiety symptoms(Pre-intervention and post-intervention (4 weeks after commencing treatment). In addition, GAD-2 will be administered at 1, 2, and 3 weeks after commencing treatment.)

研究者

发起方
Joaquim Radua
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Joaquim Radua

Leader of the IMARD group

Institut d'Investigacions Biomèdiques August Pi i Sunyer

研究点 (1)

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