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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05757180
Other study ID # G049019N
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2022
Est. completion date May 13, 2023

Study information

Verified date July 2023
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 191
Est. completion date May 13, 2023
Est. primary completion date May 13, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years to 16 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Positive Events Training (PET)
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.
CREAtive writing Training (CREAT)
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.

Locations

Country Name City State
Belgium Pius X - instituut Antwerpen
Belgium Sint Lambertuscollege Bilzen Limburg
Belgium GO! Next sportschool Hasselt Hasselt Limburg
Belgium Scholen Kindsheid Jesu Hasselt Limburg
Belgium KOBOS Secundaire Scholen Kapelle-op-den-Bos Vlaams-Brabant

Sponsors (2)

Lead Sponsor Collaborator
Prof. dr. Filip Raes Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

References & Publications (34)

Arditte Hall KA, De Raedt R, Timpano KR, Joormann J. Positive memory enhancement training for individuals with major depressive disorder. Cogn Behav Ther. 2018 Mar;47(2):155-168. doi: 10.1080/16506073.2017.1364291. Epub 2017 Aug 22. — View Citation

Askelund AD, Schweizer S, Goodyer IM, van Harmelen AL. Positive memory specificity is associated with reduced vulnerability to depression. Nat Hum Behav. 2019 Mar;3(3):265-273. doi: 10.1038/s41562-018-0504-3. Epub 2019 Jan 14. Erratum In: Nat Hum Behav. 2019 Jul;3(7):758. — View Citation

Bastin M, Nelis S, Raes F, Vasey MW, Bijttebier P. Party Pooper or Life of the Party: Dampening and Enhancing of Positive Affect in a Peer Context. J Abnorm Child Psychol. 2018 Feb;46(2):399-414. doi: 10.1007/s10802-017-0296-3. — View Citation

Bromberg U, Lobatcheva M, Peters J. Episodic future thinking reduces temporal discounting in healthy adolescents. PLoS One. 2017 Nov 22;12(11):e0188079. doi: 10.1371/journal.pone.0188079. eCollection 2017. — View Citation

Bromberg U, Wiehler A, Peters J. Episodic Future Thinking Is Related to Impulsive Decision Making in Healthy Adolescents. Child Dev. 2015 Sep-Oct;86(5):1458-68. doi: 10.1111/cdev.12390. Epub 2015 Jun 25. — View Citation

Clarke A, Friede T, Putz R, Ashdown J, Martin S, Blake A, Adi Y, Parkinson J, Flynn P, Platt S, Stewart-Brown S. Warwick-Edinburgh Mental Well-being Scale (WEMWBS): validated for teenage school students in England and Scotland. A mixed methods assessment. BMC Public Health. 2011 Jun 21;11:487. doi: 10.1186/1471-2458-11-487. — View Citation

Ducasse D, Loas G, Dassa D, Gramaglia C, Zeppegno P, Guillaume S, Olie E, Courtet P. Anhedonia is associated with suicidal ideation independently of depression: A meta-analysis. Depress Anxiety. 2018 May;35(5):382-392. doi: 10.1002/da.22709. Epub 2017 Dec 12. — View Citation

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. — View Citation

Feldman GC, Joormann J, Johnson SL. Responses to Positive Affect: A Self-Report Measure of Rumination and Dampening. Cognit Ther Res. 2008 Aug 1;32(4):507-525. doi: 10.1007/s10608-006-9083-0. — View Citation

Fredrickson BL. The role of positive emotions in positive psychology. The broaden-and-build theory of positive emotions. Am Psychol. 2001 Mar;56(3):218-26. doi: 10.1037//0003-066x.56.3.218. — View Citation

Hallford DJ, Austin DW, Takano K, Fuller-Tyszkiewicz M, Raes F. Computerized Memory Specificity Training (c-MeST) for major depression: A randomised controlled trial. Behav Res Ther. 2021 Jan;136:103783. doi: 10.1016/j.brat.2020.103783. Epub 2020 Nov 27. — View Citation

Hallford DJ, Barry TJ, Austin DW, Raes F, Takano K, Klein B. Impairments in episodic future thinking for positive events and anticipatory pleasure in major depression. J Affect Disord. 2020 Jan 1;260:536-543. doi: 10.1016/j.jad.2019.09.039. Epub 2019 Sep 9. — View Citation

Hallford DJ, Carmichael AM, Austin DW, Takano K, Raes F, Fuller-Tyszkiewicz M. A study protocol for a randomised trial of adjunct computerised memory specificity training (c-MeST) for major depression in youth: targeting cognitive mechanisms to enhance usual care outcomes in mental health settings. Trials. 2020 Jan 14;21(1):85. doi: 10.1186/s13063-019-4036-6. — View Citation

Hallford DJ, Sharma MK. Anticipatory pleasure for future experiences in schizophrenia spectrum disorders and major depression: A systematic review and meta-analysis. Br J Clin Psychol. 2019 Nov;58(4):357-383. doi: 10.1111/bjc.12218. Epub 2019 Mar 10. — View Citation

Hallford DJ, Yeow JJE, Fountas G, Herrick CA, Raes F, D'Argembeau A. Changing the future: An initial test of Future Specificity Training (FeST). Behav Res Ther. 2020 Aug;131:103638. doi: 10.1016/j.brat.2020.103638. Epub 2020 May 7. — View Citation

Jorm AF, Patten SB, Brugha TS, Mojtabai R. Has increased provision of treatment reduced the prevalence of common mental disorders? Review of the evidence from four countries. World Psychiatry. 2017 Feb;16(1):90-99. doi: 10.1002/wps.20388. — View Citation

Mojtabai R, Olfson M, Han B. National Trends in the Prevalence and Treatment of Depression in Adolescents and Young Adults. Pediatrics. 2016 Dec;138(6):e20161878. doi: 10.1542/peds.2016-1878. Epub 2016 Nov 14. — View Citation

Nearchou F, Flinn C, Niland R, Subramaniam SS, Hennessy E. Exploring the Impact of COVID-19 on Mental Health Outcomes in Children and Adolescents: A Systematic Review. Int J Environ Res Public Health. 2020 Nov 16;17(22):8479. doi: 10.3390/ijerph17228479. — View Citation

Nelis S, Bastin M, Raes F, Bijttebier P. When Do Good Things Lift You Up? Dampening, Enhancing, and Uplifts in Relation To Depressive and Anhedonic Symptoms in Early Adolescence. J Youth Adolesc. 2018 Aug;47(8):1712-1730. doi: 10.1007/s10964-018-0880-z. Epub 2018 Jun 20. — View Citation

Nelis S, Holmes EA, Raes F. Response Styles to Positive Affect and Depression: Concurrent and Prospective Associations in a Community Sample. Cognit Ther Res. 2015;39(4):480-491. doi: 10.1007/s10608-015-9671-y. — View Citation

Raes F, Hermans D, Williams JM, Demyttenaere K, Sabbe B, Pieters G, Eelen P. Reduced specificity of autobiographical memory: a mediator between rumination and ineffective social problem-solving in major depression? J Affect Disord. 2005 Aug;87(2-3):331-5. doi: 10.1016/j.jad.2005.05.004. — View Citation

Raes F, Williams JM, Hermans D. Reducing cognitive vulnerability to depression: a preliminary investigation of MEmory Specificity Training (MEST) in inpatients with depressive symptomatology. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):24-38. doi: 10.1016/j.jbtep.2008.03.001. Epub 2008 Mar 12. — View Citation

Reijntjes A, Dekovic M, Vermande M, Telch MJ. Role of depressive symptoms in early adolescents' online emotional responding to a peer evaluation challenge. Depress Anxiety. 2009;26(2):135-46. doi: 10.1002/da.20446. — View Citation

Sherdell L, Waugh CE, Gotlib IH. Anticipatory pleasure predicts motivation for reward in major depression. J Abnorm Psychol. 2012 Feb;121(1):51-60. doi: 10.1037/a0024945. Epub 2011 Aug 15. — View Citation

Simon-Saiz MJ, Fuentes-Chacon RM, Garrido-Abejar M, Serrano-Parra MD, Larranaga-Rubio E, Yubero-Jimenez S. Influence of resilience on health-related quality of life in adolescents. Enferm Clin (Engl Ed). 2018 Sep-Oct;28(5):283-291. doi: 10.1016/j.enfcli.2018.06.003. Epub 2018 Jul 20. English, Spanish. — View Citation

Skrove M, Romundstad P, Indredavik MS. Resilience, lifestyle and symptoms of anxiety and depression in adolescence: the Young-HUNT study. Soc Psychiatry Psychiatr Epidemiol. 2013 Mar;48(3):407-16. doi: 10.1007/s00127-012-0561-2. Epub 2012 Aug 8. — View Citation

Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972. — View Citation

Soer R, Six Dijkstra MWMC, Bieleman HJ, Stewart RE, Reneman MF, Oosterveld FGJ, Schreurs KMG. Measurement properties and implications of the Brief Resilience Scale in healthy workers. J Occup Health. 2019 May;61(3):242-250. doi: 10.1002/1348-9585.12041. Epub 2019 Mar 22. — View Citation

Speer ME, Delgado MR. Reminiscing about positive memories buffers acute stress responses. Nat Hum Behav. 2017 May;1(5):0093. doi: 10.1038/s41562-017-0093. Epub 2017 Apr 24. — View Citation

Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15. — View Citation

Tugade MM, Fredrickson BL. Resilient individuals use positive emotions to bounce back from negative emotional experiences. J Pers Soc Psychol. 2004 Feb;86(2):320-33. doi: 10.1037/0022-3514.86.2.320. — View Citation

Vinckier F, Gourion D, Mouchabac S. Anhedonia predicts poor psychosocial functioning: Results from a large cohort of patients treated for major depressive disorder by general practitioners. Eur Psychiatry. 2017 Jul;44:1-8. doi: 10.1016/j.eurpsy.2017.02.485. Epub 2017 Mar 8. — View Citation

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. — View Citation

Williams JM, Barnhofer T, Crane C, Herman D, Raes F, Watkins E, Dalgleish T. Autobiographical memory specificity and emotional disorder. Psychol Bull. 2007 Jan;133(1):122-48. doi: 10.1037/0033-2909.133.1.122. — View Citation

* Note: There are 34 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Change in episodic future thinking specificity (manipulation check) Episodic Future Thinking Test (EFT-T; Hallford et al., 2019) to assess episodic future thinking specificity. - Generated events will be coded as 0 or 1 (specific vs. non-specific) by the involved researchers. One week before the intervention, one week after the intervention and two months after the intervention
Other Change in positive memory specificity (manipulation check) Autobiographical Memory Test (AMT, Raes et al., 2099) to assess positive memory specificity. - Generated memories will be coded as specific vs. non-specific (1 vs. 0) by the involved researchers. One week before the intervention, one week after the intervention and two months after the intervention
Other Change in Pleasure Two single-item ratings of the anticipated/anticipatory (future) or remembered/felt pleasure (past) associated with the events participants recall/generate on the AMT and EFT-T. - 1 (not at all applicable) to 9 (strongly applicable) response rating scale presented by each generated event. One week before the intervention, one week after the intervention and two months after the intervention
Other Change in Detail and mental imagery Two single-item ratings of level of detail and mental imagery associated with the events participants recall/generate on the AMT and EFT-T respectively. - 1 (not at all applicable) to 9 (strongly applicable) response rating scale presented by each generated event. One week before the intervention, one week after the intervention and two months after the intervention
Other Change in Perceived control and likelihood Two single-item ratings of perceived control and perceived likelihood of occurrence associated with the events participants generate on the EFT-test (no parallel items for the AMT). - 1 (not at all applicable) to 9 (strongly applicable) response rating scale presented by each generated event. One week before the intervention, one week after the intervention and two months after the intervention
Other Change in Positive feelings Two additional single-items ratings of anticipated/anticipatory (future) or remembered/felt positive feelings in general (past) associated with the events participants recall/generate on the AMT and EFT-T. - 1 (not at all applicable) to 9 (strongly applicable) response rating scale presented by each generated event. One week before the intervention, one week after the intervention and two months after the intervention
Primary 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.
Primary 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 Change in Positive affect Positive Affect subscale of the Positive and Negative Affect Schedule Scales (PANAS; Watson et al., 1988) to assess positive affect - The Positive Affect subscale of the PANAS consists of 10 items (words) that describe positive feelings (e.g., "excited"). Items are rated on a 5-point Likert scale going from 1 (very slightly or not at all) to 5 (extremely), where with higher scores reflecting higher positive affect. One week before the intervention, one week after the intervention and two months after the intervention
Secondary Change in Positive affect regulation Dampening and Savoring subscale of the Responses to Positive Affect scale, child version (RPA-C; Bijttebier et al., 2012) to assess positive affect regulation - The RPA-C consists of items reflecting both dampening items (e.g., "When you felt happy, how often did you think: "I don't deserve this"?") and savoring items responses (e.g., "When you felt happy, how often did you notice that you felt full of energy?"). All 17 items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very often). One week before the intervention, one week after the intervention and two months after the intervention
Secondary Change in Anhedonia Leuven Anhedonia Self-report Scale (LASS, 2nd version; Nelis, Bastin, Raes, & Bijttebier 2018) to assess symptoms of anhedonia - The 12All 12 items (e.g., "There were few things I looked forward to.") are rated on a 5-point Likert scale going from 1 (completely untrue) to 5 (completely true) with higher scores reflecting higher levels of anhedonia. One week before the intervention, one week after the intervention and two months after the intervention
Secondary Change in Dampening Leuven Exeter Dampening Scale - General (LEDS, unpublished) to assess dampening.- The LEDS-G consists of 13 items (e.g., "I can only be happy if others are too.") that are rated on a 5-point Likert scale. Compared to the RPA dampening subscale, the LEDS-G aims to cover a larger variety of dampening appraisal styles. One week before the intervention, one week after the intervention and two months after the intervention
Secondary Change in Savoring Savouring Items for the Four-Factor Model of the Abridged Ways Of Savoring Checklist in Response to Everyday Events (Original scale Bryant and Vernoff, 2007; Four-Factor Model Chadwick, 2012) to assess savoring. - Items (e.g., "I looked for other people to share it with.") are rated on a 7-point Likert scale going from 1 (totally disagree) to 7 (totally agree), with higher scores reflecting higher levels of savoring. One week before the intervention, one week after the intervention and two months after the intervention
Secondary Change in Depressive symptoms and stress Depression, Anxiety, and Stress Scale (DASS-21; Lovibond & Lovibond, 1995) to assess basic mental health to control for baseline differences in the training groups, and to explore the generalised effect of PET on levels of depressive symptoms and stress at post-intervention and at follow-up. - The DASS-21 consists of 21 items (e.g., "I felt like my life had no meaning.") that are rated on a 4-point Likert scale going from 0 (never) to 3 (almost always). One week before the intervention, one week after the intervention and two months after the intervention
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