NCT06335615

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2023

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

22 days

First QC Date

March 21, 2024

Last Update Submit

March 21, 2024

Conditions

Keywords

AcceptanceAcceptance and Commitment TherapyBrief InterventionStudent Mental Health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • State Anxiety

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

  • Study Stress

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

  • Interoceptive awareness

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

  • Psychological Flexibility

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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

The control group follows a 20-minute online psychoeducation at home. Each participant follows this intervention individually.

Behavioral: Psychoeducation

Interventions

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.

Intervention
PsychoeducationBEHAVIORAL

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.

Control

Eligibility Criteria

Age17 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Student at the University of Amsterdam in the Bachelor's programme psychology or communication science

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Amsterdam

Amsterdam, North Holland, 1018 WS, Netherlands

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 28, 2024

Study Start

November 27, 2023

Primary Completion

December 19, 2023

Study Completion

December 19, 2023

Last Updated

March 28, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ICF, ANALYTIC CODE
Time Frame
Data will be made available with publication of the journal article. There is no specified time limit for availability.

Locations