Clinical trial NCT06978257: Digital Positive Affect Intervention Study
Official title: Protocol of a Two-Arm Randomized Controlled Trial (RCT) of Digital Positive Affect Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild to Moderate Anxiety and Depression
Keywords: anxiety
depression
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 2400
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria

* Adults aged between 21 and 64 years
* Proficient in written and spoken English
* Ability to provide informed consent
* Scores between 5 and 14 on the Generalized Anxiety Disorder-7 (GAD-7) scale OR
* Scores between 5 and 19 on the Patient Health Questionnaire-9 (PHQ-9) scale
* Scores below 6 on the Altman Self-Rating Mania (ASRM) scale
* Possess an active smartphone with a valid Singapore phone number
* Mainly based in Singapore, within the next 15 months Exclusion criteria
* Failure to meet the above inclusion criteria
* Significant suicidal thoughts within the past two weeks, defined as self-reporting "more than half the days" or "nearly every day" on the PHQ-9 Item 9.
* Received psychiatric diagnoses of bipolar disorder, disorders of psychosis, severe clinical anxiety, or severe clinical depression.
* Severe clinical anxiety (scores of 15 to 21 on the GAD-7)
* Severe clinical depression (scores of 20-27 on the PHQ-9)

Primary outcomes:
measure: Change from baseline Generalized Anxiety Disorder Symptoms at 6 weeks post-randomization
timeFrame: Baseline to 6 weeks post-randomization
measure: Change from baseline Generalized Anxiety Disorder symptoms at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
measure: Change from baseline depressive symptoms at 6 weeks post-randomization
timeFrame: Baseline to 6 weeks post-randomization
measure: Change from baseline depressive symptoms at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
Secondary outcomes:
measure: Change from baseline emotion regulation strategies at 6 weeks post-randomization
timeFrame: Baseline to 6 weeks post-randomization
measure: Change from baseline emotion regulation strategies at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
measure: Change from baseline automatic thoughts at 6 weeks post-randomization
timeFrame: Baseline to 6 weeks post-randomization
measure: Change from baseline automatic thoughts at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
measure: Change from baseline attentional control at 6 weeks post-randomization
timeFrame: Baseline to 6 weeks post-randomization
measure: Change from baseline attentional control at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
measure: Change from baseline self-compassion at 6 weeks post-randomization
timeFrame: Baseline to 6 weeks post-randomization
measure: Change from baseline self-compassion at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
measure: Change from baseline mental well-being at 6 weeks post-randomization
timeFrame: Baseline to 6 weeks post-randomization
measure: Change from baseline mental well-being at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
measure: Change from baseline positive affect at 6 weeks post-randomization
timeFrame: Baseline to 6 weeks post-randomization
measure: Change from baseline positive affect at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
measure: Change from baseline negative affect at 6 weeks post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
measure: Change from baseline negative affect at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
measure: Change from baseline anhedonia at 6 weeks post-randomization
timeFrame: Baseline to 6 weeks post-randomization
measure: Change from baseline anhedonia at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
measure: Change from baseline positive valence at 6 weeks post-randomization
timeFrame: Baseline to 6 weeks post-randomization
measure: Change from baseline positive valence systems at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
measure: Change from baseline perceived stress at 6 weeks post-randomization
timeFrame: Baseline to 6 weeks post-randomization
measure: Change from baseline perceived stress at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
measure: Change from baseline sleep quality at 6 weeks post-randomization
timeFrame: Baseline to 6 weeks post-randomization
measure: Change from baseline sleep quality at 3, 6, and 12 months post-randomization
timeFrame: Baseline to 3 months, 6 months, and 12 months post-randomization
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore (NUS)
Study officials:
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