- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07082296
- Original Trial
iCBT to Promote Emotional Well-being in University and Research Communities: Feasibility and Acceptability Study (iCBT-Academia)
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
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona, Spain
- IDIBAPS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Ability to read in Catalan or Spanish.
- Undergraduate or master's student, PhD student, or teaching and researching staff.
Exclusion Criteria (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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: University and Research Community
Participants will receive the self-guided 4-week iCBT intervention.
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iCBT-Academia is a brief, self-guided, internet-based cognitive behavioral therapy (iCBT) program specifically tailored to address the real-life challenges faced by the university and research community.
It consists of four modules, each designed to be completed over a week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Retention/compliance rates
Time Frame: Post-intervention (4 weeks after commencing treatment)
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Retention/compliance rates refer to the proportion of participants who complete the study and follow the intervention as intended.
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Post-intervention (4 weeks after commencing treatment)
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Acceptability
Time Frame: Post-intervention (4 weeks after commencing treatment)
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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.
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Post-intervention (4 weeks after commencing treatment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in affect
Time Frame: 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.
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Affect will be measured using the International Positive and Negative Affect Schedule - Short Form (I-PANAS-SF), a 10-item self-report questionnaire designed to assess positive and negative affect.
It includes two subscales: Positive Affect and Negative Affect, each comprising 5 items.
Participants rate each item on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always).
Subscale scores range from 5 to 25.
Higher scores on the Positive Affect subscale indicate greater experience of positive emotions, while higher scores on the Negative Affect subscale indicate greater experience of negative emotions.
An additional, shorter 4-item version, comprising items 6, 7, 8, and 9 (the two items with the highest factor loadings for positive affect and the two with the highest loadings for negative affect), will also be used.
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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.
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Changes in life satisfaction
Time Frame: 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.
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Life satisfaction will be measured using the Satisfaction With Life Scale (SWLS), a brief self-report questionnaire that assesses the cognitive component of subjective well-being through participants' ratings of their overall life satisfaction.
The SWLS consists of 5 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 5 to 25) will be linearly rescaled to range from 5 to 35.
Higher scores indicate greater life satisfaction.
An additional, shorter 2-item version comprising items 1 and 3 (the two items with the highest factor loadings), will also be used.
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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.
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Changes in anxiety symptoms
Time Frame: 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.
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Anxiety symptoms will be measured using the Generalized Anxiety Disorder 7-item scale (GAD-7), a brief self-report questionnaire that assesses the severity of anxiety symptoms experienced over the past two weeks.
Each of the 7 items is rated on a 4-point Likert scale (0 = not at all to 3 = nearly every day), with total scores ranging from 0 to 21.
Higher scores indicate greater severity of anxiety symptoms.
GAD-2, a shorter version with 2 items, will also be used.
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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.
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Changes in depressive symptoms
Time Frame: 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.
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Depressive symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9), a brief self-report questionnaire that assesses the severity of depressive symptoms over the past two weeks, based on DSM diagnostic criteria.
Each of the 9 items is rated on a 4-point Likert scale (0 = not at all to 3 = nearly every day), with total scores ranging from 0 to 27.
Higher scores indicate greater severity of depressive symptoms.
PHQ-2, a shorter version with 2 items, will also be used.
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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.
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Possible negative effects
Time Frame: 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.
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Possible negative effects will be assessed using the Negative Effects Questionnaire (NEQ), a brief self-report instrument designed to evaluate negative effects experienced during or after a psychological intervention.
The version used includes 20 items covering five domains: symptoms, quality, dependency, stigma, and hopelessness.
Each item captures two dimensions: (1) whether the effect occurred and was attributed to the intervention, and (2) the perceived negative impact, rated on a 5-point Likert scale from 1 (not at all) to 5 (extremely).
Total impact scores range from 20 to 100, with higher scores indicating greater perceived negative effects.
In addition, a shorter 5-item version-comprising items 6, 11, 12, 14, and 16 (the items with the highest factor loading in each domain and retained in the NEQ-20)-will also be used.
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joaquim Radua, Institut d'Investigacions Biomèdiques August Pi i Sunyer
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023BENES003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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