NCT05757180

Brief Summary

Many young people are experiencing stress-related mental health problems, with some recent studies suggesting this number is increasing. Especially now, in the context of the COVID-19 pandemic, there is a significant increase in depression and anxiety in adolescents. An important way to help address this challenge is not so much to focus on trying to repair what makes young people vulnerable but to focus on building resilience. Resilience refers to the ability to successfully deal with stressful experiences. Recent research shows that being able to vividly remember and imagine positive events can buffer the negative consequences of stress, and makes a convincing case that training adolescents in recalling and anticipating positive events would promote resilience and thereby improve their mental wellbeing. And this is exactly what the current project sets out to do for the very first time. Adolescents will receive a playful group-training in school to make them better at recalling and anticipating positive events, which is expected to help them to bounce back more swiftly from challenging or otherwise stressful life events. The investigators predict that youngsters who follow our Positive Event Training will experience more positive emotions, will show improved resilience and report better mental wellbeing. The investigators will also develop a free online training protocol for teachers so that schools can provide this resilience program on their own, without the need of external professional trainers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
191

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

February 14, 2023

Last Update Submit

July 6, 2023

Conditions

Keywords

adolescentsanhedoniadampeningepisodic future thinkingmemory specificitypositive emotionsresiliencesavoringwellbeing

Outcome Measures

Primary Outcomes (2)

  • Change in Resilience

    Connor-Davidson Resilience Scale (CD-RISC, short version) to assess resilience - This scale consists of 10 items (e.g., "Dealing with stress makes me stronger.") that are rated on a 5-point Likert scale going from 1 (not at all) to 5 (very often), with higher scores indicating higher resilience.

    1 week before the intervention, 1 week after the intervention and 2 months after the intervention.

  • Change in Mental wellbeing

    Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS; Stewart-Brown et al., 2009) to assess mental wellbeing - The SWEMWBS consists of seven statements (e.g., "I felt relaxed.") about thoughts and feelings that are scored on a 5-point Likert scale ranging from 1 (never) to 5 (always). Higher scores reflect higher mental wellbeing.

    One week before the intervention, one week after the intervention and two months after the intervention; The SWEMWBS consists of seven statements (e.g., "I felt relaxed.") about thoughts and feelings that are scored on a 5-point Likert scale ranging from

Secondary Outcomes (6)

  • Change in Positive affect

    One week before the intervention, one week after the intervention and two months after the intervention

  • Change in Positive affect regulation

    One week before the intervention, one week after the intervention and two months after the intervention

  • Change in Anhedonia

    One week before the intervention, one week after the intervention and two months after the intervention

  • Change in Dampening

    One week before the intervention, one week after the intervention and two months after the intervention

  • Change in Savoring

    One week before the intervention, one week after the intervention and two months after the intervention

  • +1 more secondary outcomes

Other Outcomes (6)

  • Change in episodic future thinking specificity (manipulation check)

    One week before the intervention, one week after the intervention and two months after the intervention

  • Change in positive memory specificity (manipulation check)

    One week before the intervention, one week after the intervention and two months after the intervention

  • Change in Pleasure

    One week before the intervention, one week after the intervention and two months after the intervention

  • +3 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Classes that will follow Positive Events Training.

Behavioral: Positive Events Training (PET)

Control group

ACTIVE COMPARATOR

Classes that will follow Bogus Control Training.

Behavioral: CREAtive writing Training (CREAT)

Interventions

PET is a group-based training program combining Memory Specificity Training (MEST; Raes, 2007) and Future Event Specificity Training (FEST; Dutch version of Hallford et al. (2020): Changing the Future: An initial test of Future Specificity Training). It comprises four sessions of 50 minutes each. The training is delivered in a standardized manner, using the Positive Event Training Manual developed for this study (content adapted from our MEST and FEST manuals). Following brief psychoeducation on the rationale, participants practice generating detailed specific memories and future events using neutral and positive cue-words. Participants are maximally supported and challenged by the trainer and by the other group-members to generate very specific and highly detailed memories and future events using mental imagery and drawing upon visual, olfactory, auditory and emotional elements of the events, including both contextual and sensory-perceptual details.

Intervention group

CREAT follows the exact same format and length as the PET training (i.e., delivered by a trainer in group over 4 x 50-minute sessions, including homework exercises). Following brief psychoeducation on the (bogus\*) rationale behind PET, participants complete a series of creative writing exercises using funny and thought-provoking writing prompts. Just as in PET, participants are maximally supported and challenged by the trainer and by the other group-members, in this case to generate completions that are as creative and funny as possible. The investigators used CREAT successfully before in an online format as a bogus control training for a memory specificity training. (\*) The investigators tell participants that these creative writing exercises have been found to be beneficial for mental wellbeing, as creative writing exercises cultivate creativity and stimulate participants' imagination skills.

Control group

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All adolescents of the selected classes of the participating schools (12-16 years; 1st and 2nd grade of secondary school) who want to take part in the study and give informed consent (own informed consent and active parental informed consent) will be allowed to take part in the study.
  • To minimize the risk of too much heterogeneity in our final sample, for instance due to context factors related to the type of education, the investigators will first recruit classes of adolescents that follow general secondary education. Future studies (after PET has been properly evaluated in this study) should also be conducted in samples of adolescents following other types of secondary education.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sint Lambertuscollege

Bilzen, Limburg, 3740, Belgium

Location

GO! Next sportschool Hasselt

Hasselt, Limburg, 3500, Belgium

Location

Scholen Kindsheid Jesu

Hasselt, Limburg, 3500, Belgium

Location

KOBOS Secundaire Scholen

Kapelle-op-den-Bos, Vlaams-Brabant, 1880, Belgium

Location

Pius X - instituut

Antwerp, 2020, Belgium

Location

Related Publications (35)

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MeSH Terms

Conditions

Anhedonia

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Filip Raes, Prof. dr.

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A cluster randomized-controlled trial design will be used with a two (condition: PET vs. active control) x three (time-point: baseline, post-training and FU) factorial-design.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 14, 2023

First Posted

March 7, 2023

Study Start

October 21, 2022

Primary Completion

May 13, 2023

Study Completion

May 13, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

The coded, pseudonomized dataset will be uploaded in a csv format to OSF (in a restricted access repository).

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The coded, pseudonomized dataset will be uploaded in a csv format to OSF (in a restricted access repository) upon publication of the research results.
Access Criteria
Coded, pseudonomized data can be shared with regulatory authorities, ethical committees, other parties that collaborate with the research team. Other researchers will only have access to the coded, pseudonomized data, and only if they agree with the confidentiality rules agreed upon within this study.

Locations