The Caring Universities Project: GetStarted RCT

Procrastination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478096
• Other study ID #: VCWE-2021-193
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: April 2023

Study information

• Verified date: August 2022
• Source: VU University of Amsterdam
• Contact: Sascha Y Struijs, PhD
• Phone: +316 48 20 62 23
• Email: s.y.struijs[@]vu.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: April 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Procrastination

Intervention

Behavioral:
• GetStarted
Guided internet-based intervention for procrastination.

Locations

Country	Name	City	State
Netherlands	Vrije Universiteit Amsterdam	Amsterdam

Sponsors (5)

Lead Sponsor	Collaborator
VU University of Amsterdam	Erasmus University Rotterdam, Leiden University, Maastricht University, Utrecht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socio demographic characteristics and additional participant information	age; gender; ethnicity; student status; study level; relationship status; whether the student is currently undergoing any treatment (pharmacotherapy/psychotherapy/both/none)	T0 (Baseline)
Other	Satisfaction with the intervention	The Client Satisfaction Questionnaire (CSQ-8) is used to measure participants' satisfaction with the overall intervention. The CSQ-8 is commonly used to measure satisfaction with online interventions. It consists of eight items on a four-point Likert scale with a total score ranging from 8 to 32, where a higher score indicates greater satisfaction.	T2 (Post-test: 4-weeks)
Other	Usability	The System Usability Scale (SUS-10) is used to measure the usability of the intervention. It consists of 10 items on a five-point Likert scale with a total score ranging from 0 to 100, where a higher score indicates greater usability.	T2 (Post-test: 4-weeks)
Other	Adherence	Adherence refers to "the degree to which the user followed the program as it was designed" (Donkin et al., 2011). The present study measures adherence by dividing the number of modules completed by a participant at time of post-test by the total number of modules in the programme, and multiplying this by 100. The resulting percentage will indicate completion rate.	T2 (Post-test: 4-weeks)
Other	Satisfaction with E-coach	The Working Alliance Inventory for guided internet interventions (WAI-I) is used to evaluate participant's satisfaction with the e-coach. The WAI-I consists of 12 items on a 5-point Likert scale with a total score ranging from 12 to 60, where higher scores indicate higher satisfaction.	T2 (Post-test: 4-weeks)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)