Clinical trial NCT05478096: The Caring Universities Project: GetStarted RCT
Official title: The Caring Universities Project: RCT Evaluating the Effectiveness of a Guided E-health Programme (GetStarted) in Reducing Procrastination in University Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Procrastination
Keywords: procrastination
guided
e-health
university students
mental health
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: Leiden University
name: Maastricht University
name: Utrecht University
name: Erasmus University Rotterdam
First posted: 2022-07-28
Enrollment: 176
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in procrastination behaviours
timeFrame: T0/T1 (Baseline) to T2/T3 (Post-test: 4-weeks) to T5 (Follow up: 6 months)
Secondary outcomes:
measure: Change in depressive symptoms
timeFrame: T1 (Baseline) to T2/T3 (Post-test: 4-weeks) to T5 (Follow up: 6 months)
measure: Change in severity of stress
timeFrame: T1 (Baseline) to T2/T3 (Post-test: 4-weeks) to T5 (Follow up: 6 months)
measure: Change in quality of life
timeFrame: T1 (Baseline) to T2/T3 (Post-test: 4-weeks) to T5 (Follow up: 6 months)
measure: Change in Anxiety symptoms
timeFrame: T1 (Baseline) to T2/T3 (Post-test: 4-weeks) to T5 (Follow up: 6 months)
Other outcomes:
measure: Socio demographic characteristics and additional participant information
timeFrame: T0 (Baseline)
measure: Satisfaction with the intervention
timeFrame: T2 (Post-test: 4-weeks)
measure: Usability
timeFrame: T2 (Post-test: 4-weeks)
measure: Adherence
timeFrame: T2 (Post-test: 4-weeks)
measure: Satisfaction with E-coach
timeFrame: T2 (Post-test: 4-weeks)
Locations:
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Amsterdam
Study officials:
affiliation: VU University of Amsterdam
name: Sascha Y Struijs, PhD
role: PRINCIPAL_INVESTIGATOR
References: