Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207214
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-11-22
Brief Title:
Evaluating an ACT Self-help Book for University Students
Sponsor:
Cardiff University
Organization:
Cardiff University
Study Overview
Official Title:
Acceptance and Commitment Therapy for University Students A Single Case Experimental Study of the Self-help Book The Unbreakable Student
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 booksappswebsites 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
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 booksappswebsites 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
Detailed Description:
Aims
The proposed research aims to assess whether reading The Unbreakable Student 6 Rules for Staying Sane at University leads to any changes in idiosyncratic student outcomes measures of student wellbeing and ACT based processes amongst a student population It also aims to explore when in the intervention any differences occur to determine which content leads to the most change for students and therefore which change mechanisms should be targeted or prioritised in future student interventions
Hypotheses
It is hypothesised that reading an ACT based self-help book will change the way students relate to their experiences and thoughts about university stress It is hypothesised that there will not be a significant change in how regularly students think about their source of stress It is hypothesised that there may be a reduction in how interfering students rate their thoughts about a stressful topic and an increase in how they rate their engagement in meaningful activities in spite of the stressors they face These hypotheses will be tested via the use of idiosyncratic target variables
It also hypothesised that there will be an increase in overall student wellbeing and ACT related processes as measured by nomothetic measures
Methodology and outcome measures
The overall study design will be a Single Case Experimental Design SCED approach
There will be an initial baseline phase where participants will each complete idiosyncratic measures every three days Participants will be randomly allocated to a baseline phase of either 2 3 or 4 weeks The idiosyncratic measures will use a Likert scale format and will assess frequency of thoughts level of interference of thoughts and ability to engage in meaningful activities despite the thoughts These will all be personalised to individual participants as per their individual target problemsource of stress which they will have identified during a screening phase These will act as dependent variables The baseline phase will be monitored for stability After this the independent variable will be introduced and participants begin reading The Unbreakable Student 6 Rules for Staying Sane at University Participants will be given 8 weeks to read the book which has 8 chapters and participants will be suggested to read 1 chapter a week Participants continue completing their idiosyncratic measures every three days throughout the intervention phase
Participants will also complete nomothetic measures These will be the Warwick-Edinburgh Mental Well-being Scale - WEMWBS to assess student wellbeing and the COMPrehensive assessment of Acceptance and Commitment Therapy processes - the CompACT measure to assess ACT processes These will be completed pre-intervention mid-intervention and post-intervention Demographic data will also be collected eg gender age course subject and year of study
Post-intervention there will be exit interviews to discuss the findings assess any external confounding events and explore student participation in the end of chapter tasks These would use a semi-structured interview schedule They would be recorded and transcribed via Teams and would be analysed using descriptive thematic analysis
Participants
The aim will be to recruit between six and 12 participants In single case designs students act as their own controls meaning the intervention can be tested using a small sample and evaluated more robustly than in an uncontrolled case study This avoids needing a large student to read an entire book due to issues with student research participation Participants will predominantly be recruited via social media
Screening
Participants will complete an online screening questionnaire to assess eligibility for the study The screening questionnaire will
Check they are registered as a Cardiff University student
Check they have no links with the author of the book
Check anything that would impact their ability to read a book eg languagedisability and any adjustments required
Identify an area of stress that the student has in relation to their university experience
Check they have not previously read the book
Check they are not taking part in any other research studies or interventions that could confound the results
Use the Clinical Outcomes in Routine Evaluation 10 CORE-10 measure to check there is no significant clinical risk
Intervention
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
Data analysis
The hypotheses will be tested using visual inspection as per usual data evaluation in SCED and also by statistical methods such as TauPAND These will be used to analyse the idiosyncratic data Furthermore clinically significant change and reliable change will be measured and will used to analyse data from the standardisednomothetic psychometric measures The interviews will be analysed using thematic analysis
The proposed research aims to assess whether reading The Unbreakable Student 6 Rules for Staying Sane at University leads to any changes in idiosyncratic student outcomes measures of student wellbeing and ACT based processes amongst a student population It also aims to explore when in the intervention any differences occur to determine which content leads to the most change for students and therefore which change mechanisms should be targeted or prioritised in future student interventions
Hypotheses
It is hypothesised that reading an ACT based self-help book will change the way students relate to their experiences and thoughts about university stress It is hypothesised that there will not be a significant change in how regularly students think about their source of stress It is hypothesised that there may be a reduction in how interfering students rate their thoughts about a stressful topic and an increase in how they rate their engagement in meaningful activities in spite of the stressors they face These hypotheses will be tested via the use of idiosyncratic target variables
It also hypothesised that there will be an increase in overall student wellbeing and ACT related processes as measured by nomothetic measures
Methodology and outcome measures
The overall study design will be a Single Case Experimental Design SCED approach
There will be an initial baseline phase where participants will each complete idiosyncratic measures every three days Participants will be randomly allocated to a baseline phase of either 2 3 or 4 weeks The idiosyncratic measures will use a Likert scale format and will assess frequency of thoughts level of interference of thoughts and ability to engage in meaningful activities despite the thoughts These will all be personalised to individual participants as per their individual target problemsource of stress which they will have identified during a screening phase These will act as dependent variables The baseline phase will be monitored for stability After this the independent variable will be introduced and participants begin reading The Unbreakable Student 6 Rules for Staying Sane at University Participants will be given 8 weeks to read the book which has 8 chapters and participants will be suggested to read 1 chapter a week Participants continue completing their idiosyncratic measures every three days throughout the intervention phase
Participants will also complete nomothetic measures These will be the Warwick-Edinburgh Mental Well-being Scale - WEMWBS to assess student wellbeing and the COMPrehensive assessment of Acceptance and Commitment Therapy processes - the CompACT measure to assess ACT processes These will be completed pre-intervention mid-intervention and post-intervention Demographic data will also be collected eg gender age course subject and year of study
Post-intervention there will be exit interviews to discuss the findings assess any external confounding events and explore student participation in the end of chapter tasks These would use a semi-structured interview schedule They would be recorded and transcribed via Teams and would be analysed using descriptive thematic analysis
Participants
The aim will be to recruit between six and 12 participants In single case designs students act as their own controls meaning the intervention can be tested using a small sample and evaluated more robustly than in an uncontrolled case study This avoids needing a large student to read an entire book due to issues with student research participation Participants will predominantly be recruited via social media
Screening
Participants will complete an online screening questionnaire to assess eligibility for the study The screening questionnaire will
Check they are registered as a Cardiff University student
Check they have no links with the author of the book
Check anything that would impact their ability to read a book eg languagedisability and any adjustments required
Identify an area of stress that the student has in relation to their university experience
Check they have not previously read the book
Check they are not taking part in any other research studies or interventions that could confound the results
Use the Clinical Outcomes in Routine Evaluation 10 CORE-10 measure to check there is no significant clinical risk
Intervention
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
Data analysis
The hypotheses will be tested using visual inspection as per usual data evaluation in SCED and also by statistical methods such as TauPAND These will be used to analyse the idiosyncratic data Furthermore clinically significant change and reliable change will be measured and will used to analyse data from the standardisednomothetic psychometric measures The interviews will be analysed using thematic analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None