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

Not Applicable

Completed

• Conditions: Anxiety; Depression
• Interventions: Behavioral: Visitor Mindset; Behavioral: Relaxing with Nature

• Registration Number: NCT05109507
• Lead Sponsor: Yale University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-10-18
• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-05
• Status Verified: 2021-12
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 530

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visitor Mindset	Visitor Mindset	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.
Relaxing with Nature	Relaxing with Nature	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
State emotional awareness, clarity, and acceptance following negative affect induction	Immediate post-intervention	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.
State non-acceptance of emotions	Immediate post-intervention	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.
Change over time in non-acceptance of emotions	Baseline to 2-week follow-up	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.
Change over time in emotional awareness, clarity, and acceptance	Baseline to 2-week follow-up	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.
Change over time in beliefs about the usefulness of negative emotions	Baseline to 2-week follow-up	Emotion Beliefs Questionnaire (EBQ). Total scores range from 0 to 16, with higher scores indicating greater beliefs that emotions are not useful or harmful
Change over time in functional impairment	Baseline to 2-week follow-up	Work and Social Adjustment Scale (WSAS). Total scores range from 0 to 40, with higher scores indicating greater functional impairment.
Change over time in beliefs about the duration of negative emotions	Baseline to 2-week follow-up	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)

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States