Mental Health Wellness 1
Conditions
Keywords
university students, single session intervention, online, self-help, mental well-being
Brief summary
The investigators want to understand the impact of a short online single session programme to improve well-being. Therefore, the investigators are investigating a self-help mental health intervention composed of four distinct modules, all designed to be completed within a single, 60-minute online session.Any university student in the UK can take part. Participants are randomly allocated to either: 1. Complete the COMET programme (lasting about 60 minutes) and to practice the skills learned over the next few weeks. Participants are asked to fill out online questionnaires (10-15 minutes) at two points in the future: two weeks from baseline, and four weeks from baseline. Or 2. Complete a few extra online questionnaires (lasting about 20-30 minutes), and fill out brief questionnaires (10-15 minutes) two weeks and four weeks later. After filling out the questionnaires in four weeks time, participants will then have the opportunity to complete the COMET programme (lasting about 60 minutes).
Detailed description
The study will use a randomised controlled trial (RCT) design, with a waiting list control (treatment as usual) group who will have the opportunity to access the intervention 4 weeks after randomisation. The intervention is digital and delivered online via Qualtrics. Participants will answer questions before completing the intervention, and at 2-week and 4-week follow-up. The single session intervention is expected to take \< 1 hour to complete, with the research study components taking \<20 minutes to complete.
Interventions
OTHERCOMET-GB
Online self-guided single session intervention - comprised of 4 modules based on the core principles of CBT, combined with principles from positive psychology. Each module includes short reading exercises, informational videos, and writing exercises. * Cognitive Restructuring (labelled Flexible Thinking) * Behavioural Activation (labelled Positive Activities) * Gratitude * Self-Compassion The initial intervention modules and assessment will take participants approximately 60-75 minutes to complete (15-20 minutes for the assessment measures only).
Sponsors
University of Reading
King's College London
University of Roehampton
University of Pennsylvania
Newcastle University
University of Bath
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Parallel groups (1:1 allocation) Randomised controlled trial (RCT) design, with a waiting list control group who will have the opportunity to access the intervention at the end of the follow-up period (i.e. 4 weeks after randomisation).
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The target population for this study are undergraduate and postgraduate students at UK universities. To be eligible to participate, an individual must be: (i) a registered undergraduate or postgraduate student at a university in the UK; and (ii) able to access the internet. Those who cannot access the internet will not be eligible, and neither will those who are under 16 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Well-being | 4 weeks post randomisation | Warwick-Edinburgh Mental Well-being Scale (WEMWBS) - has 14 items that captures participants feelings and thoughts that best describe their experience over the previous 2 weeks using a scale from 1 to 5. Higher scores indicate better wellbeing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | 2 weeks, 4 weeks post randomisation | Patient Health Questionnaire-9 (PHQ-9), a commonly used measure for depressive symptoms. The PHQ-9 has 9 items which capture the frequency of depressive symptoms over the preceding two weeks using a scale from 0-3. A score of 0-4 indicates no depression, 5-9 indicates mild depression, 10-14 indicates moderate depression, 15- 19 indicates moderately severe depression and 20-24 indicates severe depression. The PHQ-9 has a sensitivity and specificity of 88% for detecting clinical depression. |
| Anxiety symptoms | 2 weeks, 4 weeks post randomisation | General Anxiety Disorder 7-item Checklist (GAD-7), a commonly used measure for symptoms of anxiety. The GAD-7 has 7 items which capture the frequency of anxious symptoms over the preceding two weeks using a scale from 0-3. A score of 0-4 indicates no anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety and ≥15 indicates severe anxiety. The GAD-7 has a sensitivity and specificity of 89% and 82% respectively. |
| Positive and negative affect | 2 weeks, 4 weeks post randomisation | Positive and Negative Affect Schedule (PANAS), a commonly used measure of positive and negative affect. The PANAS has 20 items that captures participants feelings of positive and negative affect over the past week using a scale from 1 to 5. |
| Well-being | 2 weeks post randomisation | Warwick-Edinburgh Mental Well-being Scale (WEMWBS), a commonly used measure of well-being. The WEMWBS has 14 items that captures participants feelings and thoughts that best describe their experience over the previous 2 weeks using a scale from 1 to 5. Higher scores indicate better wellbeing. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptability (intervention arm only) | Immediately post intervention | Acceptability of Interventions Measure (AIM) |
| Appropriateness (intervention arm only) | Immediately post intervention | Intervention Appropriateness Measure (IAM) |
Countries
United Kingdom
Outcome results
None listed