Single-Session Intervention Targeting Emotional Awareness, Clarity, and Acceptance to Reduce Depression/Anxiety

Study Overview
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Brief Summary
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Two-arm, parallel group randomized clinical trial conducted via Mturk comparing a single-session web-based intervention called Visitor Mindset versus a control intervention (nature videos with relaxing music) for adults with depression and/or anxiety symptoms

Detailed Description
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Procedures include completing: (1) pre-intervention assessments; (2) one of two single-session web-based intervention (approximately 30 to 45 minutes each); (3) post-intervention assessments, including survey questions following a negative affect induction (brief film clip); and (4) a 2-week follow-up assessment.

Official Title
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Pilot Randomized Trial of Visitor Mindset: A Single-Session Self-Guided Digital Intervention Targeting Emotional Awareness, Clarity, and Acceptance Among Adults With Anxiety and/or Depression Symptoms

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: Visitor Mindset
* Behavioral: Relaxing with Nature


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years and older English-speaking At least mild anxiety and/or depression symptoms, as indicated by a score of 3 or greater on the 4-item Patient Health Questionnaire (PHQ-4) Exclusion Criteria: fail to meet above-listed inclusion criteria exit the study prior to condition randomization obvious lack of English fluency in open response questions responding with random text in open response questions respond with either copy/pasted responses from text earlier in the intervention to any of free response questions participants with a completion time less than 180 seconds for the baseline survey assessment (taking about 1.5 seconds per question) OR who fail all three attention check questions in the baseline survey, indicating very careless, random, inattentive and/or hasty responding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visitor Mindset<br>Single-session, self-guided web-based intervention ( 30 to 45 minutes) hosted on Qualtrics with animated videos, audio-guided exercises, graphics, text-based material, and interactive questions. The intervention is designed to enhance emotional awareness, clarity, and acceptance, as well as modify beliefs about the duration and usefulness of negative emotions. | Behavioral: Visitor Mindset<br>* Single-session, self-guided intervention<br>|
| Active Comparator: Relaxing with Nature<br>Single-session self-guided web-based intervention ( 30 to 45 minutes) hosted on Qualtrics with videos (real-life images), text-based material, and questions. There are five videos showing different types of nature (e.g., forest scenes, beach scenes, etc.). Each video includes a sequence of pleasant nature photos (shown about 6 seconds each) with relaxing music in the background. | Behavioral: Relaxing with Nature<br>* Single-session, self-guided intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety and depression symptoms | Patient Health Questionnaire-Anxiety Depression Scale (PHQ-ADS). Total scores range from 0 to 27, with higher scores indicating greater anxiety/depression symptoms. | Baseline to 2-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time in functional impairment | Work and Social Adjustment Scale (WSAS). Total scores range from 0 to 40, with higher scores indicating greater functional impairment. | Baseline to 2-week follow-up | 
| State emotional awareness, clarity, and acceptance following negative affect induction | Adapted state version of Emotion Regulation Skills Questionnaire (ERSQ). Total scores for each subscale range from 0 to 12, with higher scores indicating greater state emotional awareness, clarity. or acceptance. | Immediate post-intervention | 
| State non-acceptance of emotions | Non-acceptance subscale of the State Difficulties in Emotion Regulation Scale (S-DERS). Total scores range from 0 to 12, with higher scores indicating greater state emotional non-acceptance. | Immediate post-intervention | 
| Change over time in emotional awareness, clarity, and acceptance | Emotion Regulation Skills Questionnaire (ERSQ). Total scores for each subscale range from 0 to 12, with higher scores indicating greater emotional awareness, clarity. or acceptance. | Baseline to 2-week follow-up | 
| Change over time in non-acceptance of emotions | Non-acceptance subscale of the Difficulties in Emotion Regulation Scale (DERS). Total scores range from 0 to 12, with higher scores indicating greater state emotional non-acceptance. | Baseline to 2-week follow-up | 
| Change over time in beliefs about the usefulness of negative emotions | Emotion Beliefs Questionnaire (EBQ). Total scores range from 0 to 16, with higher scores indicating greater beliefs that emotions are not useful or harmful | Baseline to 2-week follow-up | 
| Change over time in beliefs about the duration of negative emotions | duration subscale (2 items) of the Leahy Emotion Schema Scale (LESS) and 2 items (When I'm upset, I believe that I will remain that way for a long time and When I'm upset, I believe that I'll end up feeling very depressed) from the modification subscale of the Difficulties in Emotion Regulation Scale (DERS). Total scores range from 0 to 16, with higher scores indicating greater maladaptive beliefs about the duration of emotions (they last will last forever) | Baseline to 2-week follow-up |