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Completed

NCT Number: NCT06335615

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

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.

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Key information

Conditions

Stress

Age range

17 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Amsterdam

Amsterdam, North Holland, 1018 WS, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Acceptance Intervention

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Psychological Well-Being

    Time frame: Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation)

    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.

Secondary outcomes

  1. State Anxiety

    Time frame: Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation)

    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.

  2. Study Stress

    Time frame: Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation)

    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)?

  3. Interoceptive awareness

    Time frame: Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation)

    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.

  4. Psychological Flexibility

    Time frame: Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation)

    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.

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Registry information

Official study title

Examining the Effectiveness, Mediators, and Moderators of a Brief Acceptance Intervention for Stress to Improve Students' Well-Being: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2024
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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