Digital Positive Affect Intervention Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-64
SponsorNational University of Singapore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Digital positive affect intervention (PAI)
BehavioralThe Positive Affect Intervention (PAI) is a fully digital, self-guided program uniquely designed to deliver weekly 30-minute online sessions focused on cultivating positive emotions, meaning, and engagement, alongside daily ecological momentary prompts delivered thrice daily over six weeks. Distinctively, the intervention seamlessly integrates multimedia content (e.g., brief weekly videos introducing each session's core principles), practical exercises, and in-the-moment reflection, aiming to reinforce positive affect skills in real time. Its structure not only emphasizes proactive skill application through digital reminders but also systematically assesses user engagement and perceived helpfulness via ecological momentary assessments and post-session feedback questionnaires. Unlike conventional digital interventions that primarily focus on symptom reduction through passive content consumption, this PAI leverages continuous ecological momentary engagement via a dedicated mobile app, e
Self-monitoring intervention
BehavioralThe self-monitoring intervention serves as an active comparator designed to isolate the effects of mood self-awareness without introducing therapeutic content. Participants in this arm receive daily prompts via the Qualtrics mEMA mobile app, three times per day over a six-week period, instructing them to track their mood and emotional states through brief ecological momentary assessments (EMAs). Unlike the digital positive affect intervention, this arm does not include psychoeducational material, skills training, or active enhancement strategies; instead, it focuses solely on routine self-monitoring to control for digital engagement and expectancy effects. This minimalist structure allows for a clean contrast between passive self-observation and active therapeutic engagement, enabling robust evaluation of the added value of the Positive Affect Intervention beyond self-monitoring alone
Treatment groups
2,400 Participants
are divided into 2 treatment groupsGroup A: Digital positive affect intervention (PAI)Experimental treatment 1 intervention
Group B: Self-monitoring interventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline Generalized Anxiety Disorder Symptoms at 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.
Time frame
Baseline to 6 weeks post-randomization2
Change from baseline Generalized Anxiety Disorder symptoms at 3, 6, 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.
Time frame
Baseline to 3 months, 6 months, and 12 months post-randomization3
Change from baseline depressive symptoms at 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.
Time frame
Baseline to 6 weeks post-randomization4
Change from baseline depressive symptoms at 3, 6, 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.
Time frame
Baseline to 3 months, 6 months, and 12 months post-randomizationSecondary outcomes
1
Change from baseline emotion regulation strategies at 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.
Time frame
Baseline to 6 weeks post-randomization2
Change from baseline emotion regulation strategies at 3, 6, 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.
Time frame
Baseline to 3 months, 6 months, and 12 months post-randomization3
Change from baseline automatic thoughts at 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.
Time frame
Baseline to 6 weeks post-randomization4
Change from baseline automatic thoughts at 3, 6, 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.
Time frame
Baseline to 3 months, 6 months, and 12 months post-randomizationSponsors and contacts
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Source ClinicalTrials.gov