A Brief Acceptance Intervention for Stress to Improve Students' Well-Being

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06335615
• Other study ID #: FMG-5790_2023
• Status: Completed
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: December 19, 2023

Study information

• Verified date: March 2024
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Brief Acceptance Intervention
The intervention consist of explanations and exercises about acceptance of stress. The intervention starts with a welcome, after which participants do jumping jacks and then breath through a straw to induce an uncomfortable experience. Next, a Chinese finger trap is used to show the automatic, but often not useful, reaction to avoid stress. Participants then watch a short video that introduces the concept of acceptance, and they do a short, guided meditation. Afterwards, they do the straw exercise again, but this time with instruction to examine and allow uncomfortable experiences. The session ends with a recap and the introduction of the home exercise. Participants install an app that reminds them every hour to do a three-second meditation in which they pay attention to their breathing and body in an accepting way.
• Psychoeducation
In the psychoeducation, participants learn about the stress response, mindfulness, and acceptance. For this, they are guided through a vignette about a student who struggles with stress and then develops a more accepting stance towards it. The psychoeducation explains how acceptance can help to deal with stress but does not instruct participants to apply this in their own life.

Locations

Country	Name	City	State
Netherlands	University of Amsterdam	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

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)