A Study Protocol on Peer Digital Acceset (PDA)

NCT05083676 | Completed

• 1 other identifier: Acceset Prospective Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mental Health Issue

Keywords

Mattering; Self-hood; Compassion; Mindfulness; Digital Peer Support Intervention; peer emotional disclosure; community; Mental Well-being; Digital biomarkers

Outcome Measures

Primary Outcomes (2)

• 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.

  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. \[doi: 10.1046/j.1525-1497.2001.016009606.x\]

  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

  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,

  Immediately before the start of digital peer support training and right after the training ends

• Active ingredients of youth mental well-being (befrienders)--compassion

  Immediately before the start of digital peer support training and right after the training ends

• Active ingredients of youth mental well-being (befrienders)--mindfulness

  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)

  baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)

Study Arms (2)

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).

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.

Behavioral: Acceset Intervention

Interventions

Acceset Intervention BEHAVIORAL

. 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.

Also known as: Digital Peer Support Intervention

Acceset Intervention; waitlist for Acceset intervention

Eligibility Criteria

• Age: 19 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• youths with high risk for suicidality detected at the time of screening with a validated psychological scale-PHQ-9.

Sponsors & Collaborators

• The N.1 Institute for Health (N.1): lead
• Acceset: collaborator

Study Sites (1)

N.1 Institute for Health

Singapore, 117456, Singapore

Location

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  PMID: 36756843 DERIVED

• Yeo G, Chang W, Lee LN, Oon M, Ho D. A Digital Peer Support Platform to Translate Web-Based Peer Support for Emerging Adult Mental Well-being: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 20;11(9):e34602. doi: 10.2196/34602.

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MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Dean Ho, PhD

  N.1 Institute for Health, National University of Singapore

  PRINCIPAL INVESTIGATOR

• GeckHong Yeo, PhD

  N.1 Institute for Health, National University of Singapore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 19, 2021
• Study Start: January 31, 2022
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 12 months and ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose-for individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.

Locations

SG (1)