Stress Clinical Trial
Official title:
Examining the Effectiveness, Mediators, and Moderators of a Brief Acceptance Intervention for Stress to Improve Students' Well-Being: A Randomized Controlled Trial
Verified date | March 2024 |
Source | VU University of Amsterdam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this randomized controlled trial is to test a brief psychological intervention that focusses on acceptance of stress in a student population. The main questions it aims to answer are: - Does this brief acceptance intervention increase the well-being of students in the short term? - By which mechanisms does this effect occur? - What are moderating factors of this effect? Half of the participants follow a one-hour intervention, which includes - psychoeducation and metaphors about stress and how acceptance can help to deal with it - experiential exercises - mindfulness meditation - mindfulness homework practice Students that receive the intervention will be compared to students that merely received psychoeducation about stress and acceptance to see if the intervention lead to larger increases in well-being.
Status | Completed |
Enrollment | 116 |
Est. completion date | December 19, 2023 |
Est. primary completion date | December 19, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years to 29 Years |
Eligibility | Inclusion Criteria: - Student at the University of Amsterdam in the Bachelor's programme psychology or communication science Exclusion Criteria: - Panic Disorder as measured with the Rapid Measurement Toolkit-20 (Batterham et al., 2020; cutoff at 9) - Asthma, Chronic Obstructive Pulmonary Disease (COPD), another lung disease (including covid-related lung complaints), or tightness of chest - Pregnancy - Physical disability that limits ability to move and jump |
Country | Name | City | State |
---|---|---|---|
Netherlands | University of Amsterdam | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
VU University of Amsterdam |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Psychological Well-Being | Psychological well-being was measured with the General Health Questionnaire-12 (GHQ-12, Goldberg & Williams, 1988), which is a unidimensional measure of mental health with good psychometric properties (Romppel et al., 2013). Higher scores on the GHQ-12 indicate more psychological distress and lower well-being. | Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation) | |
Secondary | State Anxiety | The six-item version of the Spielberger State-Trait Anxiety Inventory (STAI; Marteau & Bekker, 1992) is a brief, valid, and reliable questionnaire to assess participants' state anxiety. | Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation) | |
Secondary | Study Stress | A single question was used for study-related stress: How much stress related to studying are you currently experiencing on a scale of 0 (no stress) to 10 (extreme stress)? | Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation) | |
Secondary | Interoceptive awareness | The Multidimensional Assessment of Interoceptive Awareness (MAIA-2, Mehling et al., 2018) measured body awareness. In line with Ferentzi and colleagues (2020) and for enhanced psychometric validity, we will combine six subscales to measure a general level of interoception. | Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation) | |
Secondary | Psychological Flexibility | The Comprehensive Assessment of Acceptance and Commitment Therapy Processes questionnaire (CompACT; Francis et al., 2016) measures the underlying processes of Acceptance and Commitment Therapy. It has good psychometric properties (Francis et al., 2016). We will be especially interested in the subscale openness to experience, which corresponds to the processes of acceptance and defusion. | Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation) |
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