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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jeffrey Lambert, PhD
  • Phone Number: +44 (0)1225 384536
  • Email: jl2426@bath.ac.uk

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Procrastinate digital programme

8-week unternet-based CBT for procrastination

  • Behavioural Module: Introduction
  • Behavioural Module: Goal setting techniques
  • Behavioural Module: Motivation
  • Behavioural Module: Barriers to action
  • Behavioural Module: Managing maladaptive thoughts and beliefs
  • Behavioural Module: Value clarification
  • Behavioural Module: Moving forward
Behavioral: Digital intervention through modules
  • Introduction
  • Goal Setting Techniques
  • Motivation
  • Barriers to Action
  • Managing Maladaptive Thoughts and Beliefs
  • Value Clarification
  • Moving Forward
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bath

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Uppsala University
Linkoeping University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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