StressNCT06335615
A Brief Acceptance Intervention for Stress to Improve Students' Well-Being
A study testing Brief Acceptance Intervention and Psychoeducation in people with Stress, run by VU University of Amsterdam at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 17 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Brief Acceptance Intervention and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Nov 2023to 19 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Student at the University of Amsterdam in the Bachelor's programme psychology or communication science
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University of Amsterdam
Amsterdam, North Holland, 1018 WS
About this study
Official title: 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?
Read more
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.
- Conditions
- Stress
- Being tested
- Brief Acceptance Intervention, Psychoeducation
- Keywords
- Acceptance, Acceptance and Commitment Therapy, Brief Intervention, Student Mental Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Acceptance InterventionBehavioural
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.
PsychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group follows a one-hour in-person intervention focused on acceptance of stress. Each participant follows this intervention individually. Receives: Behavioral: Brief Acceptance Intervention |
| Control | Active comparator | The control group follows a 20-minute online psychoeducation at home. Each participant follows this intervention individually. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation)
Secondary outcomes (4)
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.
Measured: 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)?
Measured: 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.
Measured: 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.
Measured: Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start27 Nov 2023
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaap Lancee, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335615
- Sponsor's protocol ID
- FMG-5790_2023
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness, Mediators, and Moderators of a Brief Acceptance Intervention for Stress to Improve Students' Well-Being: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06335615
- Acronym / sponsor ID
- FMG-5790_2023
- Conditions
- Stress
- Keywords
- Acceptance, Acceptance and Commitment Therapy, Brief Intervention, Student Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Brief Acceptance InterventionThe intervention group follows a one-hour in-person intervention focused on acceptance of stress. Each participant follows this intervention individually. |
| Control | Active comparator | Behavioral: PsychoeducationThe control group follows a 20-minute online psychoeducation at home. Each participant follows this intervention individually. |
Who may qualify
- Ages
- 17 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Student at the University of Amsterdam in the Bachelor's programme psychology or communication science
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Acceptance InterventionThe 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. | Behavioural | Intervention |
| PsychoeducationIn 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. | Behavioural | Control |
Primary outcome
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.
4 secondary outcomes
State Anxiety
Time frame: Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation)
Study Stress
Time frame: Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation)
Interoceptive awareness
Time frame: Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation)
Psychological Flexibility
Time frame: Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Acceptance Intervention and Psychoeducation in people with Stress, run by VU University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Well-Being (time frame: Change from baseline (1 - 14 days before the intervention/psychoeducation) to post measurement (3 days after the intervention/psychoeducation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.