The Caring Universities Project: GetStarted RCT

Study Overview
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Brief Summary
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Within the Caring Universities project (study protocol VCWE- 2020-076 accepted by the VCWE), we have developed a guided e-health programme (GetStarted) designed to reduce procrastination in university students. With the current study, we aim to examine the effectiveness of GetStarted in reducing procrastination behaviour. Secondary goals are to gain an insight into pre-test to post-test differences regarding symptoms of low mood, anxiety and quality of life. Additionally, we aim to gain insight into the effects of participants' satisfaction with the intervention and Ecoach, the usability of the program, and treatment adherence on the effectiveness of the treatment.

Detailed Description
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The present study is a two-arm randomized control superiority trial. This trial will be conducted in a university setting. A guided web-based anti-procrastination programme (GetStarted) will be compared to a waiting list condition. GetStarted was developed based on existing literature and adapted in collaboration with university students to meet the specific needs of the university students. We have conducted interviews with students to understand their opinions about this program and adapted it based on their preferences and needs. The programme is based on cognitive-behavioral therapy (CBT). It comprises five main modules that are delivered via computer, laptop, tablet, or mobile phone and four optional modules. Every module consists of evidence-based information, exercises, and homework assignments. The content is delivered in text format with pictures and infographics; some modules also include video clips and audio recordings on a relevant subject. The intervention is available in both English and Dutch. Every week trained e-coaches (trained clinical psychology master students) will provide asynchronous written personalized feedback to each participant on the progress of the program and the exercises via the program platform. Measurements include pre- and post-assessment of procrastination behavior, common measures of psychopathology symptoms, quality of life, treatment adherence, program usability and participants' satisfaction with treatment and coaching. All students currently enrolled at the participating universities (Vrije Universiteit Amsterdam, Erasmus University, Universities of Leiden, Utrecht and Maastricht) are potentially eligible for the trial. Benefits of participation and remuneration for the test subjects: Students can participate in GetStarted free of charge, which will likely decrease their procrastination behavior. They do not receive any monetary incentives.

Official Title
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The Caring Universities Project: RCT Evaluating the Effectiveness of a Guided E-health Programme (GetStarted) in Reducing Procrastination in University Students

Conditions
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Procrastination

Intervention / Treatment
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* Behavioral: GetStarted


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 16 or older enrolled at one of the participating universities fluent in Dutch and/or English access to a PC or mobile device with internet access score 32 or above on the Irrational Procrastination Scale (IPS) provide informed consent. Exclusion Criteria: any suicidal risk by identifying if they (the participants) have had thoughts of killing themselves or have made plans of killing themselves in the past year and then responding to the question How likely do you think it is that you will act on this plan in the next 12 months? with somewhat likely or very likely

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The present study is a two-arm randomized control superiority trial. This trial will be conducted in a university setting. A guided web-based anti-procrastination programme (GetStarted) will be compared to a waiting list condition.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: We-based intervention for procrastination<br>GetStarted is a guided e-health application, based on cognitive-behavioral therapy (CBT). It comprises 5 main and 4 optional modules that are delivered weekly via computer, laptop, tablet, or mobile phone. Every week a trained e-coach will provide feedback on the progress of the program and the exercises via e-mail. The main modules are (1) psycho-education about procrastination (2) getting insight into one's own procrastination behavior, (3) uncovering unhelpful thoughts underlying procrastination and (4) replacing these unhelpful thoughts with helpful ones. Each module takes approximately 40 minutes to complete and participants will receive provide asynchronous written personalized feedback from their e-coaches within 48 hours (counting workdays only) after session completion. | Behavioral: GetStarted<br>* Guided internet-based intervention for procrastination.<br>|
| No Intervention: Wait list<br>Participants in the waiting list condition will receive no treatment for four weeks post-randomization. Following this, they can start the program if they choose to do so. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in procrastination behaviours | The Irrational Procrastination Scale (IPS) is used to assess procrastination tendencies by assessing extent to which participants procrastinate. This scale contains 9 items scored on a five-point Likert scale ranging from 1 (very seldom or not true to me) to 5 (very often true or true to me).The total scores can range from 9 to 45 with highers score indicating higher levels of procrastination. | T0/T1 (Baseline) to T2/T3 (Post-test: 4-weeks) to T5 (Follow up: 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms | The Patient Health Questionnaire (PHQ-9) is used as the measure of depression. This questionnaire consists of 9 items scored on a four-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total scores can range from 0 to 27, with higher scores indication more severe depressive symptoms | T1 (Baseline) to T2/T3 (Post-test: 4-weeks) to T5 (Follow up: 6 months) | 
| Change in severity of stress | The perceived stress scale (PSS-10) is used as a self-report measure of perceived stress. It consists of 10 items scored on a five-point Likert scale ranging from 0 (never) to 4 (very often). The total scores range from 0-40, with a higher score indicating higher levels of perceived stress. | T1 (Baseline) to T2/T3 (Post-test: 4-weeks) to T5 (Follow up: 6 months) | 
| Change in quality of life | The Mental Health Quality of Life questionnaire (MHQoL) is used to measure quality of life. It consists of 7 items scored on a four-point Likert scale ranging from 0 (very dissatisfied) to 3 (very satisfied). The total scores can range from 0-21 with higher scores indicating better quality of life. | T1 (Baseline) to T2/T3 (Post-test: 4-weeks) to T5 (Follow up: 6 months) | 
| Change in Anxiety symptoms | The Generalized Anxiety Disorder scale (GAD-7) is used to measure symptoms of generalized anxiety. The questionnaire consists of 7 items measured on a four-point Likert ranging from 0 (not at all) to 3 (nearly every day). The total scores range from 0 to 21 with higher scores indicating more severe GAD symptoms. | T1 (Baseline) to T2/T3 (Post-test: 4-weeks) to T5 (Follow up: 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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procrastination, guided, e-health, university students, mental health