Comparing psychological interventions in order to find out what treatments are effective in helping students cope and manage with challenges to their mental health
| ISRCTN | ISRCTN92015724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92015724 |
| Protocol serial number | None |
| Sponsor | Cardiff University |
| Funder | School of Psychology, Cardiff University |
- Submission date
- 30/08/2018
- Registration date
- 07/09/2018
- Last edited
- 10/09/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Over the past 10 years there has been a significant increase in the number of university students who disclose a mental health condition. The most common mental health problem reported by university students is depression; one research study found that 30.6% of students report suffering from depression. In addition to depression, symptoms of stress and anxiety are also reported to have increased amongst university students.
With an increasing number of students struggling with their mental health, it is important that universities offer students the opportunity to attend services that are inexpensive and are proven to help. The current study hopes to further contribute to the evidence base on the wellbeing of university students and provide evidence about what therapies are/are not effective.
Who can participate?
Students at Cardiff University
What does the study involve?
Participants will be invited to take part in a study that offers the opportunity to attend a course of therapy. Participants who enrol onto the study will be randomly allocated to 1 of 3 conditions. In two of the conditions participants will receive a therapy which is 4 weeks long, 2 hours per week, and the third condition will comprise of a waitlist control group. The therapies that are being delivered are Acceptance and Commitment Therapy (ACT) and Cognitive Behavioural Therapy (CBT); These are psychological interventions that propose to help individuals with challenges to their mental health. Participants in the waitlist control group will be offered either ACT or CBT after the other two conditions and once the post intervention data has been collected. In order to for the researchers to be able to evaluate the effectiveness of the interventions (ACT and CBT), participants in each of the conditions will be asked to complete questionnaires and a series of eye tracking tasks at varying times intervals (Participants in all 3 conditions will be asked to complete questionnaires before, during and after the interventions are delivered ; The eye tracking tasks will only be completed before and after the inventions are delivered).
What are the possible benefits and risks of participating?
It is hoped participants will learn psychological skills that will help them cope better with the stressors associated with university/everyday life. It is possible that participants may feel low in mood whilst completing questionnaires or attending the interventions and therefore the researchers involved in the study have the contact details of different mental health support services, including the student counselling service, which they will be able to give to students if they feel they need further support.
Where is the study run from?
Psychology Tower Building at Cardiff University (UK)
When is the study starting and how long is it expected to run for?
July 2018 to July 2019
Who is funding the study?
Cardiff University (UK)
Who is the main contact?
1. Dr. Cerith Waters (watersCS@cardiff.ac.uk)
2. Benjamin Annear (annearB2@cardiff.ac.uk)
Contact information
Scientific
School of Psychology
Cardiff University
Tower Building
70 Park Place
Cardiff
CF10 3AT
United Kingdom
 ORCID ID |
0000-0003-3557-1092 |
|---|---|
| Phone | 0000 |
| annearb2@cardiff.ac.uk |
Scientific
School of Psychology
Cardiff University
Tower Building
70 Park Place
Cardiff
CF10 3AT
United Kingdom
| Phone | 029 208 70709 |
|---|---|
| WatersCS@cardiff.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Acceptance and commitment therapy and cognitive behavioural therapy for stress, anxiety and depression among university students: efficacy and mechanisms of action |
| Study objectives | The current study will use a randomised controlled trial (RCT) design comparing two group-delivered active treatment conditions, Acceptance and Commitment Therapy (ACT) and Cognitive Behavioural Therapy (CBT) with a wait-list control condition. There are no known studies that evaluate and compare the effectiveness of 4 week long ACT and CBT interventions among a University students presenting with stress, anxiety and depression. |
| Ethics approval(s) | Cardiff University, School of Psychology Research Ethics Committee, 24/04/2018, EC.18.03.13.5261R |
| Health condition(s) or problem(s) studied | Stress, anxiety and depression |
| Intervention | Participants will be randomised using a web-based random number generator to the three conditions. Participants will receive either cognitive behavioural therapy (CBT), acceptance and commitment therapy (ACT) or will be allocated to a waitlist. Those in the CBT group will receive a 4 week CBT psychoeducational intervention, based on the Living Life to the Full (LLFT) programme routinely delivered in Student Wellbeing and NHS primary care mental health services in Cardiff and the Bristol area. Each session is 2 hours in duration and is delivered by trained presenters (Assistant Psychologists trained in the NHS) under the supervision of a Chartered Clinical Psychologist.The CBT intervention teaches psychological coping skills in line with the cognitive behavioural therapy model. Participants are also requested to engage in weekly skills practice outside of the 2 hour session. Those in the ACT group will receive the ACTivate your life (AYL) psychoeducation course. AYL is a group delivered psychoeducation course delivered over 4 consecutive weeks. Each session is 2 hours in duration and is delivered by trained presenters (Assistant Psychologists trained in the NHS) under the supervision of a Chartered Clinical Psychologist). AYL draws on fundamental ideas and therapeutic strategies from Acceptance and Commitment Therapy (ACT) and the course is designed to be engaging, clear and accessible, with many everyday examples used to illustrate core concepts. A series of psychological coping skills are taught each week. Course participants are requested to engage in weekly skills practice outside of the 2 hour session. Participants randomly allocated to the waitlist control group will be on a ‘waiting list for therapy’. They will be asked to complete questionnaire measures at the same time intervals as the participants in the other conditions as this will enable comparisons between groups to be made. Once all of the data has been collected participants in the waitlist control group will then be invited to attend either ACT or CBT therapy. Participants in each of the above conditions will be asked to complete the same questionnaires at the same time intervals. Participants will be asked to complete pre-intervention questionnaires within a 2 week period before starting therapy, the process measures each week during therapy and post intervention questionnaires 1, 5 and 12 weeks post therapy. Participants will also be invited to complete eye-tracking tasks 1 month before therapy and within a 2 week period post therapy. |
| Intervention type | Other |
| Primary outcome measure(s) |
The following will be assessed 1 week prior to the intervention, immediately prior to each intervention session and at 1, 5 and 12 weeks after the intervention: |
| Key secondary outcome measure(s) |
Measures 1-10 will be assessed 1 week prior to the intervention, immediately prior to each intervention session and at 1, 5 and 12 weeks after the intervention: |
| Completion date | 01/07/2019 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Students at Cardiff University 2. Aged 18 and over 3. Able to give informed consent 4. Able to read, write and understand English 5. Individuals with normal or corrected vision will be invited to take part in the eye tracking tasks |
| Key exclusion criteria | Staff members at the University are not able to participate |
| Date of first enrolment | 20/09/2018 |
| Date of final enrolment | 23/10/2018 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Cardiff University
Tower Building
70 Park Place
Cardiff
CF10 3AT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
