Digital intervention to enhance positive emotions for anxiety and depression
Protocol of a Two-Arm Randomized Controlled Trial (RCT) of Digital Positive Affect Intervention Study
This study is testing a six-week online program that helps adults with mild to moderate anxiety and depression boost their positive feelings to see if it improves their emotional well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2400 (estimated) |
| Ages | 21 Years to 64 Years |
| Sex | All |
| Sponsor | National University of Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06978257 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a six-week digital positive affect intervention (PAI) designed to improve emotional well-being in adults experiencing mild to moderate anxiety and depression. Participants will be randomly assigned to either the PAI, which includes therapeutic content and daily prompts to foster positive emotions, or an active control group that focuses on mood self-monitoring. The trial will assess various psychosocial outcomes at multiple time points, including quality of life and emotion regulation. Additionally, the study aims to identify factors that influence the intervention's effectiveness and gather feedback on its acceptability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 64 who are experiencing mild to moderate anxiety or depression and are proficient in English.
Not a fit: Patients with severe anxiety or depression, or those with significant suicidal thoughts, may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could provide a novel approach to enhancing emotional well-being and reducing symptoms of anxiety and depression.
How similar studies have performed: While traditional positive affect therapies have shown promise, this digital approach is relatively novel and has limited empirical evaluations.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Singapore
- National University of Singapore (NUS) — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Nur Hani Zainal, Ph.D., M.A.
- Email: hanizainal@nus.edu.sg
- Phone: +6565161126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.