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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Behavioral: Brief Acceptance Intervention; Behavioral: Psychoeducation

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1018 WS
      • University of Amsterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention group follows a one-hour in-person intervention focused on acceptance of stress. Each participant follows this intervention individually.	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.
Active Comparator: Control; The control group follows a 20-minute online psychoeducation at home. Each participant follows this intervention individually.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: VU University of Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; Brief Intervention; Acceptance; Student Mental Health
• Other Study ID Numbers: FMG-5790_2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All anonymized individual participant data will be shared. Demographic information that may lead to identification of individuals, such as open questions about education and gender will be removed.
• IPD Sharing Time Frame: Data will be made available with publication of the journal article. There is no specified time limit for availability.
• IPD Sharing Supporting Information Type: ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No