Well-Being, PsychologicalNCT06207214
Evaluating an ACT Self-help Book for University Students
A study testing Self-help book for university students. in people with Well-Being, Psychological, run by Cardiff University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- Self-help book for university students.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2024to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Based at Cardiff University (study to be completed remotely)
Cardiff
About this study
Official title: Acceptance and Commitment Therapy for University Students: A Single Case Experimental Study of the Self-help Book "The Unbreakable Student"
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.
Read more
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.
Read the 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 problem/source 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 (e.g. 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 (e.g. language/disability) 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 Tau/PAND). 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 standardised/nomothetic psychometric measures. The interviews will be analysed using thematic analysis.
- Conditions
- Well-Being, Psychological
- Being tested
- Self-help book for university students.
- Keywords
- Acceptance and Commitment Therapy, Self-help, University students, Single Case Design
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help book for university students.Other
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).
| Study group | Role | What they receive |
|---|---|---|
| Self-help book for University Students | Experimental | The Unbreakable Student: 6 Rules for Staying Sane at University by Dr Nic Hooper. Receives: Other: Self-help book for university students. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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)
Measure of overall wellbeing. Minimum score is 14 and maximum score is 70. A higher score indicates better wellbeing outcomes.
Measured: 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)
Measure of psychological flexibility. For this measure, participants rate items on a 7-point Likert scale (which goes from 0 meaning strongly disagree, to 6, meaning strongly agree), with some items being reversed scored.
Scores are then calculated for each of the subscales (openness to experience, behavioural awareness, valued action) and a total score is completed by adding these together.
The minimum score is 0 and the maximum score is 138. A higher score on this measure, represents greater psychological flexibility.
Measured: Baseline, mid-intervention (week 4 of the book reading phase) and follow-up (1 week after completing the book reading phase).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start24 Feb 2024
- Primary completionAug 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Phillips, Cardiff University
- Investigators
- Victoria Phillips, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207214
- Sponsor's protocol ID
- ACTSelfHelpBookStudents2023
- Status last verified
- Jul 2024
- First submitted
- 22 Nov 2023
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa
Morley S. (2017). Single case methods in clinical psychology: A practical guide. Routledge.
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.
PubMed 30527785Stewart-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.
PubMed 11192277Jacobson 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.
PubMed 2002127Morley, 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for University Students: A Single Case Experimental Study of the Self-help Book "The Unbreakable Student"
- ClinicalTrials.gov ID
- NCT06207214
- Acronym / sponsor ID
- ACTSelfHelpBookStudents2023
- Conditions
- Well-Being, Psychological
- Keywords
- Acceptance and Commitment Therapy, Self-help, University students, Single Case Design
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 problem/source 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 (e.g. 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 (e.g. language/disability) 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 Tau/PAND). 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 standardised/nomothetic psychometric measures. The interviews will be analysed using thematic analysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-help book for University Students | Experimental | Other: Self-help book for university students.The Unbreakable Student: 6 Rules for Staying Sane at University by Dr Nic Hooper. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-help book for university students.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). | Other | Self-help book for University Students |
Primary outcome
Frequency of thoughts about idiosyncratic stressor.
Time frame: 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).
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).
Impact of thoughts about idiosyncratic stressor.
Time frame: 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).
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).
Engagement in meaningful activities.
Time frame: 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).
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).
2 secondary outcomes
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time frame: 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)
Time frame: Baseline, mid-intervention (week 4 of the book reading phase) and follow-up (1 week after completing the book reading phase).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- BackgroundBraun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa
- BackgroundMorley S. (2017). Single case methods in clinical psychology: A practical guide. Routledge.
- Background: PubMed 30527785Kazdin 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.
- Background: PubMed 11192277Stewart-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.
- Background: PubMed 2002127Jacobson 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.
- BackgroundMorley, 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Phillips principal investigator
Cardiff University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help book for university students. in people with Well-Being, Psychological, run by Cardiff University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of thoughts about idiosyncratic stressor. (time frame: 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06207214, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.