Mental Health IssuePDANCT05083676
A Study Protocol on Peer Digital Acceset (PDA)
A study testing Acceset Intervention in people with Mental Health Issue, run by The N.1 Institute for Health (N.1) at 1 site in Singapore.
Trial summary
This protocol delineates a randomized controlled trial for evaluating the implementation and clinical effectiveness of Assecet, a digital peer support intervention for youth mental well-being, which comprises two components. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Acceset Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 31 Jan 2022to 2 Feb 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 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- youths aged 19 to 25 selective (distressed but healthy)
- primary indicative (exhibiting some symptoms but can't formally diagnose for anxiety, /depression or mental health disorder).
Who cannot join
- --youths with high risk for suicidality detected at the time of screening with a validated psychological scale-PHQ-9.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Protocol on Peer Digital Acceset (PDA): A Randomized Controlled Trial to Translate Online Peer Support for Youth Mental Well-being
This protocol delineates a randomized controlled trial for evaluating the implementation and clinical effectiveness of Assecet, a digital peer support intervention for youth mental well-being, which comprises two components. The digital peer support training curriculum aims to equip youth befrienders (i.e., peers who provide support) with knowledge and skills in harnessing four active ingredients of youth mental well-being-specifically, Mattering, selfhood, compassion, and mindfulness, in providing effective peer support for seekers (peers who seek support). The Acceset intervention that involves three components-digital biomarkers of psychological well-being, peer emotional disclosure process and community engagement.
Read the detailed description
Background: The burgeoning mental health issues among emerging adults (ages 19 to 25) worldwide has fuelled concerns about youths' widespread experiences of emotional distress, specifically concerning anxiety and depression, and coping mechanisms. Digital peer support intervention has demonstrated varying degrees of clinical effectiveness for positive health and psychological outcomes across different developmental stages. The onset of the COVID-19 pandemic has resulted in prolonged isolation and reduced social connections, and emerging literature is amounting to the import of digital peer emotional disclosure and support for young people psychological well-being. However, much remains to be explored regarding implementation and clinical effectiveness-how best to conduct digital peer intervention in support of youths' psychological well-being, and the associated mechanism of change.
Objective: This protocol delineates a randomized controlled trial for evaluating the implementation and clinical effectiveness of Assecet, a digital peer support intervention for youth mental well-being, which comprises two components. The digital peer support training curriculum aims to equip youth befrienders (i.e., peers who provide support) with knowledge and skills in harnessing four active ingredients of youth mental well-being-specifically, Mattering, selfhood, compassion, and mindfulness, in providing effective peer support for seekers (peers who seek support). The Acceset intervention that involves three components-digital biomarkers of psychological well-being, peer emotional disclosure process and community engagement.
Methods: Participants will consist of 100 students ages 19 to 25 from the National University of Singapore to engage with the Acceset platform. At the time of recruitment, individuals will be screened for inclusion and exclusion criteria based on self-reporting. The qualified participants (seekers) will be randomly allocated into two arms. Arm 1 (n = 50) seekers will engage with the Acceset platform for a period of 3 weeks, together with befrienders (n = 30) and moderators (n = 30). Arm 2 (n = 50) a control group will be placed on a waitlist for Acceset intervention. These individuals will be age and gender matched with the intervention group (i.e., arm 1). Their mental well-being, as well as their help seeking behavior, at the same time points and via the same questionnaire battery will be compared with those in arm 1. Both seekers and befrienders will be monitored using a questionnaire battery listed (including help seeking behaviors beyond the Acceset platform) at 4 time points: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects). The implementation outcomes will be adoption and fidelity evaluation of the digital peer support training curriculum, the feasibility and acceptability of Acceset in providing continuous access to online peer support throughout the duration of the seekers' engagement. The clinical outcomes will include Mattering, self-hood, compassion, mindfulness, psychological well-being scores for befrienders and seekers, and additionally perceived social support for seekers. The mechanism of change linking befrienders' support and seekers' mental well-being will be assessed using latent growth curve modelling.
Data Collection, Management and Analyses: We conducted power analysis to ascertain the adequate sample size needed for the randomized controlled trial, specifically in comparing the intervention and control groups on different clinical outcomes, so that the study has sufficient power to detect valid effects. The study sample size of n = 50 for intervention and n = 50 for control is needed because of multiple dependent variables measuring clinical outcomes included in the study and the testing of implementation outcomes (i.e., feasibility, utility). In dealing with missing data, we will first determine if missing data is missing completely at random (MCAR). If missing data is not systematic, as indicated by the non-significant result from Little's Missing Completely at Random Test, this study will handle missing data using full information maximum likelihood imputation.
Data will be analyzed and interpreted through three means. First, independent sample t-tests will be conducted whenever we need to compare intervention vs. control group on the different clinical outcomes in this study. Second, to elucidate the content of emotional disclosure on the Acceset platform, particularly in relation to the four active ingredients of psychological well-being (i.e., Mattering, self-hood, compassion and mindfulness), we will perform topic modelling using Latent Dirichlet Allocation (LDA) analyses with R to filter the huge amount of data available and drill down relevant themes and topics. LDA is an advanced statistical method that increases precision and accuracy in coding as compared to the exclusive use of qualitative approach /analyses. Third, to compare the mechanism of change , we will use Latent Growth Curve Modelling (LCM) to examine the trajectories of Acceset intervention in predicting the change in clinical outcomes experienced by youths. LCM elucidates whether an increasing trend in befrienders' digital peer support predicts increasing trends in youths' sense of Mattering, self-hood, compassion, mindfulness, and psychological well-being (i.e., clinical outcomes).
- Conditions
- Mental Health Issue
- Being tested
- Acceset Intervention
- Keywords
- Mattering, Self-hood, Compassion, Mindfulness, Digital Peer Support Intervention, peer emotional disclosure, community, Mental Well-being, Digital biomarkers
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceset InterventionBehavioural
Also called Digital Peer Support Intervention
. The intervention comprises of: i) Digital peer support training for youth befrienders to equip them with the knowledge and application of the four active ingredients-Mattering, selfhood, compassion, and mindfulness-to provide effective peer support as they respond to youth seekers' emotional experiences.
ii) Acceset Intervention with features or digital markers of psychological well-being, peer emotional disclosure process and community engagement.
| Study group | Role | What they receive |
|---|---|---|
| Acceset Intervention | Experimental | The qualified participants (seekers) will be randomly allocated into two arms. Arm 1 (n = 50) seekers will engage with the Acceset platform for a period of 3 weeks, together with befrienders (n = 30) and moderators (n = 30). Both seekers and befrienders will be monitored using a questionnaire battery listed (including help seeking behaviors beyond the Acceset platform) at 4 time points: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects). Receives: Behavioral: Acceset Intervention |
| waitlist for Acceset intervention | Active comparator | Arm 2 (n = 50) a control group will be placed on a waitlist for Acceset intervention. These individuals will be age and gender matched with the intervention group (i.e., arm 1). Their mental well-being, as well as their help seeking behavior, at the same time points and via the same questionnaire battery will be compared with those in arm 1. Receives: Behavioral: Acceset Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Anxiety; 7-item General Anxiety Disorder Questionnaire; Self-reported measure; score range: 0 to 3, with higher score indicating greater anxiety severity Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of internal medicine 2006 May 22;166(10):1092-7.
Measured: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Change in depression scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Depression; 9-item Patient Health Questionnaire; Self-reported measure; score range: 0 to 3, with higher scores reflecting greater depression severity Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine 2001 Sep; 16(9):606-13. [doi: 10.1046/j.1525-1497.2001.016009606.x]
Measured: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Secondary outcomes (12)
Active ingredients of youth mental well-being (befrienders)--Mattering
Content or qualitative analysis of befrienders' responses using the Rosenberg Mattering scale; score range: 1 to 4, with higher score indicating greater sense of mattering.
Rosenberg, M., \& McCullough, B. C. (1981). Mattering: Inferred significance and mental health among adolescents. Research in Community \& Mental Health, 2, 163-182.
Measured: Immediately before the start of digital peer support training and right after the training ends
Active ingredients of youth mental well-being (befrienders)--self-hood,
Content or qualitative analysis of befrienders' responses using three sub-scales on Self-knowledge: the internal self in you that reflects on things on hindsight Interpersonal self: how our self evolves based on who we are with Self as agent: the self that you build up based on the choices you make to achieve a future target score range: 1 to 4, with higher score indicating stronger self-hood
Baumeister, R. F. (2010). The self. In R. F. Baumeister \& E. J. Finkel (Eds.), Advanced social psychology: The state of the science (pp. 139-175). Oxford University Press.)
Measured: Immediately before the start of digital peer support training and right after the training ends
Active ingredients of youth mental well-being (befrienders)--compassion
Content or qualitative analysis of befrienders' responses using the Fears of Compassion Scales. Score range: 0 to 4, lower scores indicate greater compassion (i.e., decreased fear of compassion).
Self-Compassion Scale (SCS; Neff 2003). score range: 1 to 5, with higher score indicating higher compassion
Gilbert, P., McEwan, K., Matos, M., \& Rivis, A. (2010). Fears of compassion: Development of three selfreport measures. Psychology and Psycotherapy: Theory, Research and Practice. doi: 10.1348/147608310X526511.
Neff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250. doi:10.1080/15298860309027.
Measured: Immediately before the start of digital peer support training and right after the training ends
Active ingredients of youth mental well-being (befrienders)--mindfulness
Content or qualitative analysis of befrienders' responses using the mindfulness subscale from the Self-Compassion Scale (SCS; Neff 2003a). score range: 1 to 5, with higher score indicating higher mindfulness
Neff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250. doi:10.1080/15298860309027.
Measured: Immediately before the start of digital peer support training and right after the training ends
Change in College adjustment scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Student Adaptation to College Questionnaire; Self-reported measure; score range: 1 to 9, with higher score indicating better adjustment.
Baker RW, Siryk B. Measuring adjustment to college. Journal of counseling psychology 1984 Apr;31(2):179.
Measured: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Change in perceived social support across 4 time points (seekers): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Multidimensional Scale of Perceived Social Support (MSPSS); Self-reported measure; score range: 1 to 7, with higher score indicating greater perceived social support.
Zimet GD Dahlem N Zimet SG Farley GK 1994 The Multidimensional Scale of Perceived Social Support (MSPSS) In J. F.Kevin (Ed.) The measures for clinical practice: A sourcebook Vol 2 Adults(2nd ed.) New York The Free Press
Measured: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Change in Mattering scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Rosenberg Mattering scale; Self-reported measure; score range: 1 to 4, with higher score indicating greater sense of mattering.
Rosenberg, M., \& McCullough, B. C. (1981). Mattering: Inferred significance and mental health among adolescents. Research in Community \& Mental Health, 2, 163-182.
Measured: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Client Satisfaction (seekers)
Client Satisfaction Questionnaire (CSQ-8); Self-reported measure, score range: 1 to 4, with higher score indicating greater satisfaction Attkisson, C. C., \& Greenfield, T. K. (2004). The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In M. E. Maruish (Ed.), The use of psychological testing for treatment planning and outcomes assessment: Instruments for adults (pp. 799-811). Lawrence Erlbaum Associates Publishers.
Measured: 3 weeks (the end of the intervention)
Client Satisfaction (befriender; digital peer support training program)
Client Satisfaction Questionnaire (CSQ-8); Self-reported measure, score range: 1 to 4, with higher score indicating greater satisfaction Attkisson, C. C., \& Greenfield, T. K. (2004). The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In M. E. Maruish (Ed.), The use of psychological testing for treatment planning and outcomes assessment: Instruments for adults (pp. 799-811). Lawrence Erlbaum Associates Publishers.
Measured: immediately after digital peer support training workshop
Focus group interview to assess barriers and facilitators of implementation and clinical effectiveness (befrienders, moderators)
- In assessing IMPLEMENTATION outcomes (i.e., whether Acceset intervention is feasible and acceptable), we will discuss with befrienders and moderators the following:
- Whether Acceset acts as a timely intervention i.e., in supporting youth seekers when they needed peer support? 2. Whether using Acceset is acceptable and satisfactory in terms of befrienders' attitudes towards the use of Acceset as an intervention (e.g., "I found Acceset easy to use")? ii. In assessing CLINICAL outcomes (i.e., whether Acceset improves or impacts positively the mental health outcomes), we will discuss with befrienders and moderators the following:
- Meaningful Aspect of Health: Whether and how Acceset supports youth seekers in their emotion management.
- Concept of Interest: Whether and how Acceset practically measures specific elements of emotion management using the emotion sticker pack.
- Endpoints: Whether and how Acceset captures precisely data that reflects outcomes of interest.
Measured: 3 weeks (the end of the intervention)
Change in Giving social support scores across 4 time points (befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects).
Giving instrumental support to others (GISO); Self-reported measure, score range: Yes or No, with more Yes indicating a greater extent of giving instrumental support.
Brown SL, Nesse RM, Vinokur AD, Smith DM. Providing social support may be more beneficial than receiving it: Results from a prospective study of mortality. Psychological Science 2003 Jul;14(4):320-7.
Measured: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Burnout (befrienders)
Oldenburg Burnout Inventory; Self-reported measure, score range: 1 to 4, with higher score indicating greater extent of burnout.
Demerouti E, Mostert K, Bakker AB. Burnout and work engagement: a thorough investigation of the independency of both constructs. Journal of Occupational Health Psychology 2010 Jul;15(3):209.
Measured: 3 weeks (the end of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start31 Jan 2022
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We propose an interventional prospective study with hybrid design that evaluates both implementation of Acceset platform (e.g., fidelity, adoption, and utility), as well as clinical outcomes (e.g., anxiety and depressive symptoms) using randomized controlled trials. The intervention comprises of two components: (1) digital peer support training and (2) digital intervention involving three features, specifically emotionality, motivations and functional improvement serving as digital markers of psychological well-being, the peer emotional disclosure process, as well as community engagement.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The N.1 Institute for Health (N.1)
- Sponsor type
- University, hospital or other
- Collaborators
- Acceset
- Responsible party
- Sponsor
- Investigators
- Dean Ho, PhD, Principal investigator, N.1 Institute for Health, National University of SingaporeGeckHong Yeo, PhD, Study director, N.1 Institute for Health, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083676
- Sponsor's protocol ID
- Acceset Prospective Study
- Acronym
- PDA
- Status last verified
- Feb 2023
- First submitted
- 15 Sep 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in article publication, after deidentification (text, tables, figures, and appendices)
Publications
Marshall SK, Tilton-Weaver L. Adolescents' perceived mattering to parents and friends: Testing cross-lagged associations with psychosocial well-being. Int J Behav Dev 2019;43:541-52.
Flett GL, Zangeneh M. Mattering as a vital support for people during the COVID-19 pandemic: The benefits of feeling and knowing that someone cares during times of crisis. J Concurr Disord 2020;2:106-23.
Elliott G, Kao S, Grant A-M. Mattering: Empirical validation of a social-psychological concept. Self Identity 2004;3:339-54.
Flett G, Khan A, Su C. Mattering and psychological well-being in college and university students: Review and recommendations for campus-based initiatives. Int J Ment Health Addict 2019;17:667-80.
Flett GL, Nepon T. Mattering versus self-esteem in university students: associations with regulatory focus, social feedback, and psychological distress. J Psychoeduc Assess 2020;38:663-74.
Joeng JR, Turner SL. Mediators between self-criticism and depression: Fear of compassion, self-compassion, and importance to others. J Couns Psychol. 2015 Jul;62(3):453-463. doi: 10.1037/cou0000071. Epub 2015 Mar 23.
PubMed 25798874Marshall SK. Do I matter? Construct validation of adolescents' perceived mattering to parents and friends. J Adolesc. 2001 Aug;24(4):473-90. doi: 10.1006/jado.2001.0384.
PubMed 11549327Rayle AD, Chung KY. Revisiting first-year college students' mattering: Social support, academic stress, and the mattering experience. J Coll Student Retent Res Theory Pract 2007;9:21-37.
Marshall SK. Relative contributions of perceived mattering to parents and friends in predicting adolescents' psychological well-being. Percept Mot Skills. 2004 Oct;99(2):591-601. doi: 10.2466/pms.99.2.591-601.
PubMed 15560349Taylor J, Turner RJ. A longitudinal study of the role and significance of mattering to others for depressive symptoms. J Health Soc Behav. 2001 Sep;42(3):310-25.
PubMed 11668776Demir M, Davidson I. Toward a better understanding of the relationship between friendship and happiness: Perceived responses to capitalization attempts, feelings of mattering, and satisfaction of basic psychological needs in same-sex best friendships as predictors of happines. J Happiness Stud 2013;14:525-50.
Dixon SK, Kurpius SER. Depression and college stress among university undergraduates: Do mattering and self-esteem make a difference? J Coll Stud Dev 2008;49:412-24.
Flett GL, Su C, Ma L, et al. Mattering as a unique resilience factor in Chinese children: A comparative analysis of predictors of depression. Int J Child Adolesc Resil 2016;4:91-102.
Flett GL, Burdo R, Nepon T. Mattering, insecure attachment, rumination, and self-criticism in distress among university students. Int J Ment Health Addict 2020.
Baumeister RF. Self-concept, self-esteem, and identity. Personal. Contemp. theory Res., 1999, p. 339-75.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Protocol on Peer Digital Acceset (PDA): A Randomized Controlled Trial to Translate Online Peer Support for Youth Mental Well-being
- ClinicalTrials.gov ID
- NCT05083676
- Acronym / sponsor ID
- PDA / Acceset Prospective Study
- Conditions
- Mental Health Issue
- Keywords
- Mattering, Self-hood, Compassion, Mindfulness, Digital Peer Support Intervention, peer emotional disclosure, community, Mental Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The N.1 Institute for Health (N.1)University, hospital or other
- Collaborators
- Acceset
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 19 Oct 2021 (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.
This protocol delineates a randomized controlled trial for evaluating the implementation and clinical effectiveness of Assecet, a digital peer support intervention for youth mental well-being, which comprises two components. The digital peer support training curriculum aims to equip youth befrienders (i.e., peers who provide support) with knowledge and skills in harnessing four active ingredients of youth mental well-being-specifically, Mattering, selfhood, compassion, and mindfulness, in providing effective peer support for seekers (peers who seek support). The Acceset intervention that involves three components-digital biomarkers of psychological well-being, peer emotional disclosure process and community engagement.
Detailed description
Background: The burgeoning mental health issues among emerging adults (ages 19 to 25) worldwide has fuelled concerns about youths' widespread experiences of emotional distress, specifically concerning anxiety and depression, and coping mechanisms. Digital peer support intervention has demonstrated varying degrees of clinical effectiveness for positive health and psychological outcomes across different developmental stages. The onset of the COVID-19 pandemic has resulted in prolonged isolation and reduced social connections, and emerging literature is amounting to the import of digital peer emotional disclosure and support for young people psychological well-being. However, much remains to be explored regarding implementation and clinical effectiveness-how best to conduct digital peer intervention in support of youths' psychological well-being, and the associated mechanism of change.
Objective: This protocol delineates a randomized controlled trial for evaluating the implementation and clinical effectiveness of Assecet, a digital peer support intervention for youth mental well-being, which comprises two components. The digital peer support training curriculum aims to equip youth befrienders (i.e., peers who provide support) with knowledge and skills in harnessing four active ingredients of youth mental well-being-specifically, Mattering, selfhood, compassion, and mindfulness, in providing effective peer support for seekers (peers who seek support). The Acceset intervention that involves three components-digital biomarkers of psychological well-being, peer emotional disclosure process and community engagement.
Methods: Participants will consist of 100 students ages 19 to 25 from the National University of Singapore to engage with the Acceset platform. At the time of recruitment, individuals will be screened for inclusion and exclusion criteria based on self-reporting. The qualified participants (seekers) will be randomly allocated into two arms. Arm 1 (n = 50) seekers will engage with the Acceset platform for a period of 3 weeks, together with befrienders (n = 30) and moderators (n = 30). Arm 2 (n = 50) a control group will be placed on a waitlist for Acceset intervention. These individuals will be age and gender matched with the intervention group (i.e., arm 1). Their mental well-being, as well as their help seeking behavior, at the same time points and via the same questionnaire battery will be compared with those in arm 1. Both seekers and befrienders will be monitored using a questionnaire battery listed (including help seeking behaviors beyond the Acceset platform) at 4 time points: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects). The implementation outcomes will be adoption and fidelity evaluation of the digital peer support training curriculum, the feasibility and acceptability of Acceset in providing continuous access to online peer support throughout the duration of the seekers' engagement. The clinical outcomes will include Mattering, self-hood, compassion, mindfulness, psychological well-being scores for befrienders and seekers, and additionally perceived social support for seekers. The mechanism of change linking befrienders' support and seekers' mental well-being will be assessed using latent growth curve modelling.
Data Collection, Management and Analyses: We conducted power analysis to ascertain the adequate sample size needed for the randomized controlled trial, specifically in comparing the intervention and control groups on different clinical outcomes, so that the study has sufficient power to detect valid effects. The study sample size of n = 50 for intervention and n = 50 for control is needed because of multiple dependent variables measuring clinical outcomes included in the study and the testing of implementation outcomes (i.e., feasibility, utility). In dealing with missing data, we will first determine if missing data is missing completely at random (MCAR). If missing data is not systematic, as indicated by the non-significant result from Little's Missing Completely at Random Test, this study will handle missing data using full information maximum likelihood imputation.
Data will be analyzed and interpreted through three means. First, independent sample t-tests will be conducted whenever we need to compare intervention vs. control group on the different clinical outcomes in this study. Second, to elucidate the content of emotional disclosure on the Acceset platform, particularly in relation to the four active ingredients of psychological well-being (i.e., Mattering, self-hood, compassion and mindfulness), we will perform topic modelling using Latent Dirichlet Allocation (LDA) analyses with R to filter the huge amount of data available and drill down relevant themes and topics. LDA is an advanced statistical method that increases precision and accuracy in coding as compared to the exclusive use of qualitative approach /analyses. Third, to compare the mechanism of change , we will use Latent Growth Curve Modelling (LCM) to examine the trajectories of Acceset intervention in predicting the change in clinical outcomes experienced by youths. LCM elucidates whether an increasing trend in befrienders' digital peer support predicts increasing trends in youths' sense of Mattering, self-hood, compassion, mindfulness, and psychological well-being (i.e., clinical outcomes).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We propose an interventional prospective study with hybrid design that evaluates both implementation of Acceset platform (e.g., fidelity, adoption, and utility), as well as clinical outcomes (e.g., anxiety and depressive symptoms) using randomized controlled trials. The intervention comprises of two components: (1) digital peer support training and (2) digital intervention involving three features, specifically emotionality, motivations and functional improvement serving as digital markers of psychological well-being, the peer emotional disclosure process, as well as community engagement.
| Arm | Type | Receives |
|---|---|---|
| Acceset Intervention | Experimental | Behavioral: Acceset InterventionThe qualified participants (seekers) will be randomly allocated into two arms. Arm 1 (n = 50) seekers will engage with the Acceset platform for a period of 3 weeks, together with befrienders (n = 30) and moderators (n = 30). Both seekers and befrienders will be monitored using a questionnaire battery listed (including help seeking behaviors beyond the Acceset platform) at 4 time points: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects). |
| waitlist for Acceset intervention | Active comparator | Behavioral: Acceset InterventionArm 2 (n = 50) a control group will be placed on a waitlist for Acceset intervention. These individuals will be age and gender matched with the intervention group (i.e., arm 1). Their mental well-being, as well as their help seeking behavior, at the same time points and via the same questionnaire battery will be compared with those in arm 1. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- youths aged 19 to 25 selective (distressed but healthy)
- primary indicative (exhibiting some symptoms but can't formally diagnose for anxiety, /depression or mental health disorder).
Key exclusion criteria (1 listed)
- --youths with high risk for suicidality detected at the time of screening with a validated psychological scale-PHQ-9.
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 |
|---|---|---|
| Acceset InterventionAlso: Digital Peer Support Intervention. The intervention comprises of: i) Digital peer support training for youth befrienders to equip them with the knowledge and application of the four active ingredients-Mattering, selfhood, compassion, and mindfulness-to provide effective peer support as they respond to youth seekers' emotional experiences. ii) Acceset Intervention with features or digital markers of psychological well-being, peer emotional disclosure process and community engagement. | Behavioural | Acceset Intervention, waitlist for Acceset intervention |
Primary outcome
Change in anxiety scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Time frame: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Anxiety; 7-item General Anxiety Disorder Questionnaire; Self-reported measure; score range: 0 to 3, with higher score indicating greater anxiety severity Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of internal medicine 2006 May 22;166(10):1092-7.
Change in depression scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Time frame: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Depression; 9-item Patient Health Questionnaire; Self-reported measure; score range: 0 to 3, with higher scores reflecting greater depression severity Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine 2001 Sep; 16(9):606-13. [doi: 10.1046/j.1525-1497.2001.016009606.x]
12 secondary outcomes
Active ingredients of youth mental well-being (befrienders)--Mattering
Time frame: Immediately before the start of digital peer support training and right after the training ends
Active ingredients of youth mental well-being (befrienders)--self-hood,
Time frame: Immediately before the start of digital peer support training and right after the training ends
Active ingredients of youth mental well-being (befrienders)--compassion
Time frame: Immediately before the start of digital peer support training and right after the training ends
Active ingredients of youth mental well-being (befrienders)--mindfulness
Time frame: Immediately before the start of digital peer support training and right after the training ends
Change in College adjustment scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Time frame: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Change in perceived social support across 4 time points (seekers): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Time frame: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Change in Mattering scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Time frame: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Client Satisfaction (seekers)
Time frame: 3 weeks (the end of the intervention)
Client Satisfaction (befriender; digital peer support training program)
Time frame: immediately after digital peer support training workshop
Focus group interview to assess barriers and facilitators of implementation and clinical effectiveness (befrienders, moderators)
Time frame: 3 weeks (the end of the intervention)
Change in Giving social support scores across 4 time points (befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects).
Time frame: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Burnout (befrienders)
Time frame: 3 weeks (the end of the intervention)
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 2 Mar 2023.
- BackgroundMarshall SK, Tilton-Weaver L. Adolescents' perceived mattering to parents and friends: Testing cross-lagged associations with psychosocial well-being. Int J Behav Dev 2019;43:541-52.
- BackgroundFlett GL, Zangeneh M. Mattering as a vital support for people during the COVID-19 pandemic: The benefits of feeling and knowing that someone cares during times of crisis. J Concurr Disord 2020;2:106-23.
- BackgroundElliott G, Kao S, Grant A-M. Mattering: Empirical validation of a social-psychological concept. Self Identity 2004;3:339-54.
- BackgroundFlett G, Khan A, Su C. Mattering and psychological well-being in college and university students: Review and recommendations for campus-based initiatives. Int J Ment Health Addict 2019;17:667-80.
- BackgroundFlett GL, Nepon T. Mattering versus self-esteem in university students: associations with regulatory focus, social feedback, and psychological distress. J Psychoeduc Assess 2020;38:663-74.
- Background: PubMed 25798874Joeng JR, Turner SL. Mediators between self-criticism and depression: Fear of compassion, self-compassion, and importance to others. J Couns Psychol. 2015 Jul;62(3):453-463. doi: 10.1037/cou0000071. Epub 2015 Mar 23.
- Background: PubMed 11549327Marshall SK. Do I matter? Construct validation of adolescents' perceived mattering to parents and friends. J Adolesc. 2001 Aug;24(4):473-90. doi: 10.1006/jado.2001.0384.
- BackgroundRayle AD, Chung KY. Revisiting first-year college students' mattering: Social support, academic stress, and the mattering experience. J Coll Student Retent Res Theory Pract 2007;9:21-37.
- Background: PubMed 15560349Marshall SK. Relative contributions of perceived mattering to parents and friends in predicting adolescents' psychological well-being. Percept Mot Skills. 2004 Oct;99(2):591-601. doi: 10.2466/pms.99.2.591-601.
- Background: PubMed 11668776Taylor J, Turner RJ. A longitudinal study of the role and significance of mattering to others for depressive symptoms. J Health Soc Behav. 2001 Sep;42(3):310-25.
- BackgroundDemir M, Davidson I. Toward a better understanding of the relationship between friendship and happiness: Perceived responses to capitalization attempts, feelings of mattering, and satisfaction of basic psychological needs in same-sex best friendships as predictors of happines. J Happiness Stud 2013;14:525-50.
- BackgroundDixon SK, Kurpius SER. Depression and college stress among university undergraduates: Do mattering and self-esteem make a difference? J Coll Stud Dev 2008;49:412-24.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in article publication, after deidentification (text, tables, figures, and appendices)
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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.
Dean Ho, PhD principal investigator
N.1 Institute for Health, National University of Singapore
GeckHong Yeo, PhD study director
N.1 Institute for Health, National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceset Intervention in people with Mental Health Issue, run by The N.1 Institute for Health (N.1) at 1 site in Singapore.
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 2 inclusion and 1 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 2 Mar 2023. 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 Singapore. 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?
Change in anxiety scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects) (time frame: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05083676, which also lists 58 linked publications.
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 2 Mar 2023.