Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-26 @ 11:16 PM
Study NCT ID:
NCT06978257
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Positive Affect Intervention Study
Sponsor:
National University of Singapore
Organization:
Study Overview
Official Title:
Protocol of a Two-Arm Randomized Controlled Trial (RCT) of Digital Positive Affect Intervention Study
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Anxiety and depression are highly prevalent mental health disorders that impose a significant burden on individuals and public health systems worldwide (GBD 2019 Mental Disorders Collaborators, 2022). Although many existing treatments focus on symptom reduction through targeting negative emotions, fewer interventions specifically enhance positive emotional experiences, despite growing evidence that low positive affect is a key feature of both anxiety and depression. Face-to-face psychologist-led positive affect therapy (PAT) is a promising intervention that aims to cultivate positive emotions, engagement, and meaning, potentially leading to greater improvements in emotional well-being than traditional approaches (Craske et al., 2019). However, empirical evaluations of digitally-delivered, asynchronously-coached, scalable versions of the PAT remain limited (Craske et al., 2024; Firth et al., 2017). The present study thus aims to investigate the comparative efficacy of a digital positive affect intervention (PAI) in reducing symptoms of anxiety and depression and enhancing overall mental health outcomes. We utilize a two-arm randomized controlled trial (RCT) design to investigate the effectiveness of a six-week digitally delivered positive affect intervention (vs. self-monitoring active control; Zainal \& Newman, 2023) in reducing self-reported symptoms of anxiety and depression, as well as other secondary psychosocial outcomes, including sleep quality, quality of life, and emotion regulation. The treatment program comprises weekly evidence-based therapeutic material delivered online, and daily mental health (MH) mobile application prompts delivered thrice a day for the 6-week treatment period, based on evidence-based positive affect therapy principles. The active comparator comprises self-monitoring MH mobile application prompts for the 6-week treatment period. All participants will be assessed on several psychosocial outcomes at mid-treatment, post-treatment, and at 3-, 6-, and 12-month follow-up. The study hypothesizes that participants randomized to the digital PAI will experience greater improvement in anxious and depressive symptoms both immediately after treatment and up to a year later, compared to the self-monitoring MH app. Findings will contribute to growing evidence that digital PAI is an efficacious and feasible treatment to target and enhance positive emotions and related mental health outcomes in adults experiencing anxiety and depression.
Detailed Description:
The present two-arm randomized controlled trial rigorously evaluates the efficacy of a six-week digitally-delivered positive affect intervention (PAI) compared to a self-monitoring active control among adults reporting symptoms of anxiety or depression. Participants (N=2400), recruited from the National University of Singapore and the broader community, are randomized to one of two arms: (1) the PAI, which provides weekly evidence-based therapeutic content via Qualtrics alongside daily ecological momentary prompts via mEMA Ilumivu platform to cultivate positive affect, or (2) an active control that engages participants in mood self-monitoring through a mental health mobile application. The intervention is designed to target positive emotion enhancement as a core mechanism for improving emotional well-being, reducing anxious and depressive symptoms, and bolstering resilience factors. Assessments are administered at baseline, mid-intervention (Week 3), post-intervention (Week 6), and follow-ups at 3, 6, and 12 months, capturing a comprehensive suite of psychosocial outcomes including quality of life, sleep quality, and emotion regulation capacities.
The study further investigates mediators and moderators to elucidate how and for whom the intervention confers benefit, providing granular insight into mechanisms of change. Subjects in the PAI arm also complete post-treatment assessments of satisfaction and cultural relevance to assess acceptability and contextual fit, an important consideration for digital mental health interventions (DMHIs). Both arms receive regular ecological momentary assessments three times daily to reinforce engagement and capture in-the-moment affective experiences. With its fully digital, scalable design, the trial not only tests clinical effectiveness but also addresses feasibility and user engagement, contributing meaningfully to the growing literature on positive emotion-focused digital interventions and their potential for integration into stepped-care mental health frameworks. This work is poised to advance understanding of digital therapeutic strategies that extend beyond symptom reduction to actively build psychological resilience and flourishing.
The study further investigates mediators and moderators to elucidate how and for whom the intervention confers benefit, providing granular insight into mechanisms of change. Subjects in the PAI arm also complete post-treatment assessments of satisfaction and cultural relevance to assess acceptability and contextual fit, an important consideration for digital mental health interventions (DMHIs). Both arms receive regular ecological momentary assessments three times daily to reinforce engagement and capture in-the-moment affective experiences. With its fully digital, scalable design, the trial not only tests clinical effectiveness but also addresses feasibility and user engagement, contributing meaningfully to the growing literature on positive emotion-focused digital interventions and their potential for integration into stepped-care mental health frameworks. This work is poised to advance understanding of digital therapeutic strategies that extend beyond symptom reduction to actively build psychological resilience and flourishing.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: