Digital Positive Affect Intervention Study

Not Applicable

Recruiting

• Conditions: Mild to Moderate Anxiety and Depression

• Registration Number: NCT06978257
• Lead Sponsor: National University of Singapore

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.

Study Timeline

• Study Start: 2025-04-01
• Study First Submitted: 2025-05-10
• Study First Submitted QC: 2025-05-10
• Study First Posted: 2025-05-18
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Primary Completion: 2029-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline Generalized Anxiety Disorder Symptoms at 6 weeks post-randomization	Baseline to 6 weeks post-randomization	Generalized Anxiety Disorder-7 (GAD-7) scale contains 8 items measuring the frequency and intensity of anxiety symptoms, rated on a scale of 0-3 (0 = not at all, 3 = nearly every day). Higher scores reflect a greater reduction in anxiety symptoms.
Change from baseline Generalized Anxiety Disorder symptoms at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	Generalized Anxiety Disorder-7 (GAD-7) scale contains 8 items measuring the frequency and intensity of anxiety symptoms, rated on a scale of 0-3 (0 = not at all, 3 = nearly every day). Higher scores reflect a greater reduction in anxiety symptoms.
Change from baseline depressive symptoms at 6 weeks post-randomization	Baseline to 6 weeks post-randomization	Patient Health Questionnaire-9 (PHQ-9) measures the severity and frequency of depressive symptoms with nine items rated on a scale of 0 to 3 (0 = not at all, 3 = nearly every day). Higher scores indicate a greater reduction in depressive symptoms.
Change from baseline depressive symptoms at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	Patient Health Questionnaire-9 (PHQ-9) measures the severity and frequency of depressive symptoms with nine items rated on a scale of 0 to 3 (0 = not at all, 3 = nearly every day). Higher scores indicate a greater reduction in depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
Change from baseline self-compassion at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	The Self-Compassion Scale - Short Form (SCS-SF) assesses the frequency of self-compassionate behaviors and provides an evaluation of how individuals treat themselves during difficult times. 12 items are rated on a scale of 1 to 5 (1 = almost never, 5 = almost always). Higher scores indicate greater increases in self-compassion.
Change from baseline self-compassion at 6 weeks post-randomization	Baseline to 6 weeks post-randomization	The Self-Compassion Scale - Short Form (SCS-SF) assesses the frequency of self-compassionate behaviors and provides an evaluation of how individuals treat themselves during difficult times. 12 items are rated on a scale of 1 to 5 (1 = almost never, 5 = almost always). Higher scores indicate greater increases in self-compassion.
Change from baseline emotion regulation strategies at 6 weeks post-randomization	Baseline to 6 weeks post-randomization	The Emotion Regulation Questionnaire (ERQ) measures individuals' tendencies to regulate their emotions through cognitive reappraisal and expressive suppression. 10 items are rated on a scale of 1 to 7 (1 = strongly disagree, 7 = strongly agree). Higher scores indicate higher tendency to use that particular emotion regulation strategy.
Change from baseline emotion regulation strategies at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	The Emotion Regulation Questionnaire (ERQ) measures individuals' tendencies to regulate their emotions through cognitive reappraisal and expressive suppression. 10 items are rated on a scale of 1 to 7 (1 = strongly disagree, 7 = strongly agree). Higher scores indicate higher tendency to use that particular emotion regulation strategy.
Change from baseline automatic thoughts at 6 weeks post-randomization	Baseline to 6 weeks post-randomization	The Automatic Thoughts Questionnaire (ATQ) assesses the frequency of negative automatic thoughts associated with depression. Eight items are rated on a scale of 1 to 5 (1 = not at all, 5 = all the time). Higher scores indicate greater reductions in the frequency of negative thoughts.
Change from baseline automatic thoughts at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	The Automatic Thoughts Questionnaire (ATQ) assesses the frequency of negative automatic thoughts associated with depression. Eight items are rated on a scale of 1 to 5 (1 = not at all, 5 = all the time). Higher scores indicate greater reductions in the frequency of negative thoughts.
Change from baseline attentional control at 6 weeks post-randomization	Baseline to 6 weeks post-randomization	The Attentional Control Scale (ACS) assesses individuals' ability to focus and shift attention in the presence of distractions. 20 items are rated on a scale of 1 to 4 (1 = almost never, 4 = always). Higher scores indicate greater reductions in problems with regulating attention efficiently.
Change from baseline attentional control at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	The Attentional Control Scale (ACS) assesses individuals' ability to focus and shift attention in the presence of distractions. 20 items are rated on a scale of 1 to 4 (1 = almost never, 4 = always). Higher scores indicate greater reductions in problems with regulating attention efficiently.
Change from baseline mental well-being at 6 weeks post-randomization	Baseline to 6 weeks post-randomization	The Mental Health Continuum - Short Form (MHC-SF) assesses overall mental well-being across emotional, psychological, and social dimensions. 17 items are rated on a scale of 0 to 5 (0 = never, 5 = every day). Higher scores indicate greater increases in flourishing.
Change from baseline mental well-being at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	The Mental Health Continuum - Short Form (MHC-SF) assesses overall mental well-being across emotional, psychological, and social dimensions. 17 items are rated on a scale of 0 to 5 (0 = never, 5 = every day). Higher scores indicate flourishing.
Change from baseline positive affect at 6 weeks post-randomization	Baseline to 6 weeks post-randomization	The Positive and Negative Affect Schedule (PANAS) - PA subscale measures the extent to which an individual experiences positive emotion. 10 items are rated on a scale of 1 to 5 (1 = very slightly or not at all, 5 = extremely). Higher scores indicate greater increases in positive affect.
Change from baseline positive affect at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	The Positive and Negative Affect Schedule (PANAS) - PA subscale measures the extent to which an individual experiences positive emotion. 10 items are rated on a scale of 1 to 5 (1 = very slightly or not at all, 5 = extremely). Higher scores indicate greater increases in positive affect.
Change from baseline negative affect at 6 weeks post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	The Positive and Negative Affect Schedule (PANAS) - NA subscale measures the extent to which an individual experiences positive emotion. 10 items are rated on a scale of 1 to 5 (1 = very slightly or not at all, 5 = extremely). Higher scores indicate greater increases in negative affect.
Change from baseline negative affect at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	The Positive and Negative Affect Schedule (PANAS) - NA subscale measures the extent to which an individual experiences positive emotion. 10 items are rated on a scale of 1 to 5 (1 = very slightly or not at all, 5 = extremely). Higher scores indicate greater increases in negative affect.
Change from baseline anhedonia at 6 weeks post-randomization	Baseline to 6 weeks post-randomization	The Dimensional Anhedonia Rating Scale (DARS) measures anhedonia by assessing desire, motivation, effort, and consummatory pleasure across four domains: hobbies, food/drink, social activities, and sensory experiences.17 items are rated on a 5-point scale of not at all to very much. Higher scores indicate greater reductions in anhedonia.
Change from baseline anhedonia at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	The Dimensional Anhedonia Rating Scale (DARS) measures anhedonia by assessing desire, motivation, effort, and consummatory pleasure across four domains: hobbies, food/drink, social activities, and sensory experiences.17 items are rated on a 5-point scale of not at all to very much. Higher scores indicate greater reductions in anhedonia.
Change from baseline positive valence at 6 weeks post-randomization	Baseline to 6 weeks post-randomization	The Positive Valence Systems Scale (PVSS) assesses the positive valence system on several dimensions of rewards, food, physical touch and social interactions. Twenty-one items are rated on a scale of 1 to 9 (1 = extremely untrue of me, 9 = extremely true of me). Higher scores indicate stronger or more frequent responsiveness to a wide range of rewarding experiences.
Change from baseline positive valence systems at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	The Positive Valence Systems Scale (PVSS) assesses the positive valence system on several dimensions of rewards, food, physical touch and social interactions. 21 items are rated on a scale of 1 to 9 (1 = extremely untrue of me, 9 = extremely true of me). Higher scores indicate stronger or more frequent responsiveness to a wide range of rewarding experiences.
Change from baseline perceived stress at 6 weeks post-randomization	Baseline to 6 weeks post-randomization	The Perceived Stress Scale (PSS) measures the degree to which individuals appraise situations in their lives as stressful, unpredictable, and uncontrollable. 10 items are rated on a scale of 0 to 4 (0 = never, 4 = very often). Higher scores indicate greater reductions in levels of perceived stress.
Change from baseline perceived stress at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	The Perceived Stress Scale (PSS) measures the degree to which individuals appraise situations in their lives as stressful, unpredictable, and uncontrollable. 10 items are rated on a scale of 0 to 4 (0 = never, 4 = very often). Higher scores indicate greater reductions in levels of perceived stress.
Change from baseline sleep quality at 6 weeks post-randomization	Baseline to 6 weeks post-randomization	The Pittsburgh Sleep Quality Indicator (PSQI) assesses quality of sleep over a one-month period. The PSQI consists of 19 items that generate scores for seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. These components are summed to yield a global score ranging from 0 to 21. Higher scores indicate greater reductions in poor sleep quality.
Change from baseline sleep quality at 3, 6, and 12 months post-randomization	Baseline to 3 months, 6 months, and 12 months post-randomization	The Pittsburgh Sleep Quality Indicator (PSQI) assesses quality of sleep over a one-month period. The PSQI consists of 19 items that generate scores for seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. These components are summed to yield a global score ranging from 0 to 21. Higher scores indicate greater reductions in poor sleep quality.

Trial Locations

Locations (1)

National University of Singapore (NUS); 🇸🇬 Singapore, Singapore