NCT06207214

Brief Summary

Background to the project: More and more university students are reporting poor mental health, which has resulted in long waiting lists for student support services. Given this context, self-help solutions, (which means giving students ideas in books/apps/websites that they can try in their own time to help with their problems), are becoming more important. Rationale for the project: There are many self-help resources for students but not many of them are well-researched. This research project will test a self-help book called "The Unbreakable Student: 6 Rules for Staying Sane at University". Methodology: A small group of students (approximately 12) will complete questionnaires at three time points (prior to reading the book, whilst reading the book and after reading the book). They will also answer four questions sent via text message, every three days throughout the study. These will relate to a particular aspect of university life which they have identified as stressful. They will also be interviewed afterwards, to give information about their experiences of reading the book and use of the end of chapter tasks etc. Purpose: The purpose is to find out if the book is helpful for students and, if so, which parts were the most helpful. Hypotheses: The book will help students to be less bothered by difficult thoughts, such that they might find them less interfering and may feel more engaged in meaningful activities. The book will also improve student wellbeing.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 24, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

November 22, 2023

Last Update Submit

July 16, 2024

Conditions

Keywords

Acceptance and Commitment TherapySelf-helpUniversity studentsSingle Case Design

Outcome Measures

Primary Outcomes (3)

  • Frequency of thoughts about idiosyncratic stressor.

    Participants will be asked to rate how often they have had thoughts about their idiosyncratic stressor, on a scale of 0-10 (0 = not very often at all, 10 = all the time).

    Participants will complete this measure every 3 days, for the duration of their baseline phase (randomly allocated) and for the duration of the intervention phase (8 weeks).

  • Impact of thoughts about idiosyncratic stressor.

    Participants will be asked to rate how interfering their thoughts about their idiosyncratic stressor have been, on a scale of 0-10 (0 = not interfering at all, 10 = very interfering).

    Participants will complete this measure every 3 days, for the duration of their baseline phase (randomly allocated) and for the duration of the intervention phase (8 weeks).

  • Engagement in meaningful activities.

    Participants will be asked to rate how engaged they feel in meaningful activities, in spite of any thoughts about their idiosyncratic stressor, on a scale of 0-10 (0 = not very engaged, 10 = fully engaged).

    Participants will complete this measure every 3 days, for the duration of their baseline phase (randomly allocated) and for the duration of the intervention phase (8 weeks).

Secondary Outcomes (2)

  • Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

    Baseline, mid-intervention (week 4 of the book reading phase) and follow-up (1 week after completing the book reading phase).

  • Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)

    Baseline, mid-intervention (week 4 of the book reading phase) and follow-up (1 week after completing the book reading phase).

Study Arms (1)

Self-help book for University Students

EXPERIMENTAL

The Unbreakable Student: 6 Rules for Staying Sane at University by Dr Nic Hooper.

Other: Self-help book for university students.

Interventions

The intervention being tested, is a self-help book for university students based on Acceptance and Commitment Therapy. The book was published in 2021 and is called "The Unbreakable Student: 6 Rules for Staying Sane at University". The book is by Dr Nic Hooper. The self-help book will be posted in paper form to all participants. There are 8 chapters in the book and participants will be given eight weeks to read the book at home (with a suggestion of reading one chapter per week).

Self-help book for University Students

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Registered as a current Cardiff University student.
  • Proficient in English.
  • Have an adequate reading level.
  • Identify as experiencing a non-clinical, university or study related difficulty. Examples include: Exam/presentation nerves, feelings of loneliness/stress/anxiety/low mood, binge drinking, procrastination, feelings of burnout, academic/course worries, unhealthy lifestyle choices.

You may not qualify if:

  • Must not be a Cardiff University psychology student, due to potential social desirability bias, associated with being from the same school as the book author.
  • Must not have read "The Unbreakable Student: 6 Rules for Staying Sane at University".
  • Must not be in concurrent research studies/receiving concurrent psychological support, including psychoeducational, therapeutic or self-help interventions. This is to ensure valid conclusions can be drawn about the impact of the book.
  • Must not present with heightened risk during recruitment, as screened for by the CORE-10. This will be defined as a score within the moderate-severe/severe range (which is a score of 20 or higher) and/or indication of suicidal intent as indicated on the risk item. This is to ensure participant safety, whilst also ensuring a sample that reflects current levels of student distress. Any students not eligible due to risk will be signposted to services such as student support or their General Practitioner (GP).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Based at Cardiff University (study to be completed remotely)

Cardiff, United Kingdom

Location

Related Publications (6)

  • Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa

    BACKGROUND
  • Morley S. (2017). Single case methods in clinical psychology: A practical guide. Routledge.

    BACKGROUND
  • Kazdin AE. Single-case experimental designs. Evaluating interventions in research and clinical practice. Behav Res Ther. 2019 Jun;117:3-17. doi: 10.1016/j.brat.2018.11.015. Epub 2018 Dec 2.

    PMID: 30527785BACKGROUND
  • Stewart-Brown S, Evans J, Patterson J, Petersen S, Doll H, Balding J, Regis D. The health of students in institutes of higher education: an important and neglected public health problem? J Public Health Med. 2000 Dec;22(4):492-9. doi: 10.1093/pubmed/22.4.492.

    PMID: 11192277BACKGROUND
  • Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.

    PMID: 2002127BACKGROUND
  • Morley, S., Dowzer, C.N. (2014) Manual for the Leeds Reliable Change Indicator: Simple excel applications for the analysis of individual patient and group data. University of Leeds, Leeds, UK.

    BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Victoria Phillips

    Cardiff University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (Trainee Clinical Psychologist)

Study Record Dates

First Submitted

November 22, 2023

First Posted

January 16, 2024

Study Start

February 24, 2024

Primary Completion

August 1, 2024

Study Completion

November 1, 2024

Last Updated

July 18, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

All data will be retained in line with Cardiff University's Records Retention Schedule. The research team also aim to publish this project in a relevant journal, upon completion of the write-up. Any data made available as part of this publication process, will be fully anonymised.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Any anonymised data which is included as part of the final report, will be made available from the point of publication and will be in the public domain indefinitely. All other data stored by Cardiff University, will be managed in line with the Records Retention Schedule.

Locations