- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06157710
Randomised Controlled Trial of a Digital Programme for Procrastination in UK University Students
May 7, 2024 updated by: Jeffrey Lambert, University of Bath
The aim of this study is to evaluate the effect of an 8-week self-directed internet based CBT intervention on various psychological outcomes for young students struggling with procrastination in the UK.
The psychological outcomes consist of motivation, depressive symptoms, impulsivity and anxiety.
More specifically, the study aims to compare the effect of the intervention vs waitlist control at 8 weeks on primary and secondary outcomes.
Additionally, the study aims to explore whether changes in primary and secondary outcomes as the result of the intervention are mediated or moderated by key intervention processes.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jeffrey Lambert, PhD
- Phone Number: +44 (0)1225 384536
- Email: jl2426@bath.ac.uk
Study Locations
-
-
-
Bath, United Kingdom
- Recruiting
- University of Bath
-
Contact:
- Jeffrey Lambert, PhD
- Email: jl2426@bath.ac.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Resident in the UK
- Fluent in English
- Aged between 16 and 24 years of age
- Have access to computer or smartphone
- Score at least 40 points on the Pure Procrastination Scale (indicating difficulties with procrastination)
Exclusion Criteria:
- Ongoing psychological treatment
- New course of change in dose of psychotropic medication in the last two months (self-reported)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Procrastinate digital programme
8-week unternet-based CBT for procrastination
|
|
|
No Intervention: Waitlist control
Wait-list control group. They do not receive the weekly modules though they are asked to complete 4-week and 8-week online surveys. They will be allowed to revive the intervention after 8 weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procrastination: Pure Procrastination Scale (PPS; Rozental, Forsell, et al., 2014)
Time Frame: Baseline, WK4, WK8
|
measures procrastination by using 12 items to detect and determine dysfunctional delay.
The higher the score the more likely the individual is to delay an activity or task
|
Baseline, WK4, WK8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographics
Time Frame: Baseline
|
Age, gender, ethnicity, whether they were the first person in their family to attend university, international student status, course type, year of study, and method of recruitment.
|
Baseline
|
|
Clinical Perfectionism Questionnaire (CPQ) (Fairburn et al., 2003)
Time Frame: Baseline, WK4, WK8
|
Assessment of cognitive, behavioural, and affective aspects of setting goals and striving to meet them.
This scale has 12 items that assess clinical perfectionism.
Items 2 and 8 are reverse-scored.The CPQ items are scored based on the individual's experiences over the past 28 days.
The scale utilises a 4-point Likert scale ranging from 1 with the statement "not at all" to 4 with the statement "all the time".
Higher scores on the CPQ indicate higher levels of perfectionism.
|
Baseline, WK4, WK8
|
|
Depressive symptoms: Patient health questionnaire-8 (PHQ-8) (Kroenke et al., 2008)
Time Frame: Baseline, WK4, WK8
|
This assessment measures depressive symptoms.
The questionnaire asks how often participants have been bothered or felt affected by eight possible issues or symptoms over the past 2 weeks (e.g., "feeling down, depressed, or hopeless,".
The scale consists of eight of the nine criteria to determine depression.
A score on the PHQ-8 ≥10 represents clinically significant depression.
|
Baseline, WK4, WK8
|
|
Anxiety symptoms: General Anxiety Disorder Scale (GAD-7) (Spitzer et al., 2006)
Time Frame: Baseline, WK4, WK8
|
This scale is used to assess anxiety using 7 items relating to worry symptoms in the last 2 weeks.
The scores on the scale range from 0 to 21.
There are cut off points to indicate different anxiety levels.
The scores of 5,10 and 15 show the thresholds for mild anxiety, moderate anxiety, and severe anxiety.
participants have been bothered or felt affected by eight possible issues or symptoms over the past 2 weeks (e.g., "feeling down, depressed, or hopeless,".
The scale consists of eight of the nine criteria to determine depression.
A score on the PHQ-8 ≥10 represents clinically significant depression.
|
Baseline, WK4, WK8
|
|
Impulsivity: Short form Barratt Impulsiveness Scale (Spinella 2009)
Time Frame: Baseline, WK4, WK8
|
Assessment of 15 items for impulsivity.
The scale focuses on non planning, motor impulsivity, and attention impulsivity.
Higher scores are indicative of more impulsivity.
|
Baseline, WK4, WK8
|
|
International physical activity questionnaire short form (Lee et al., 2011
Time Frame: Baseline, WK4, WK8
|
The questionnaire consists of 9 items and it asks participants about their physical activity in the last 7 days before completing the form.
It explores how often participants engaged with physical activity ranging at four levels: vigorous-intensity, moderate-intensity, walking, and sitting.
|
Baseline, WK4, WK8
|
|
Behavioural activation for depression scale (BATDS-SF) (Manos et al., 2011)
Time Frame: Baseline, WK4, WK8
|
Assessment of experienced pleasure from daily activities over the past week.
It consists of 9 items on 7 point scales from 0 to 6. 0 being "not at all" to 6 "completely".
|
Baseline, WK4, WK8
|
|
Intervention acceptability and appropriateness using the Intervention Appropriateness Measure (IAM), acceptability of Interventions Measure (AIM) and feasibility of intervention measure
Time Frame: WK4, WK8
|
This scale is used to measure how appropriate the intervention will be on the participants.
This assessment uses 4 item measures which focus on how likely it is that the implementation of the intervention will be successful on the participants.
|
WK4, WK8
|
|
Usage data from intervention platform (e.g., time spend on modules, completion of worksheets)
Time Frame: Baseline to WK8
|
Assessing how far and how much of each module was completed based on time spent and whether worksheets were completed.
|
Baseline to WK8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
November 27, 2023
First Submitted That Met QC Criteria
November 27, 2023
First Posted (Actual)
December 6, 2023
Study Record Updates
Last Update Posted (Actual)
May 9, 2024
Last Update Submitted That Met QC Criteria
May 7, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Procrastinate2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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