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

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

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

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Visitor Mindset; Behavioral: Relaxing with Nature

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.

• Study Type: Interventional
• Enrollment (Actual): 530
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Visitor Mindset; Single-session, self-guided intervention
Active Comparator: 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.	Behavioral: Relaxing with Nature; Single-session, self-guided intervention

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-compassion	Self-Compassion Scale (SCS). Total scores range from 0 to 48, with higher scores indicating greater self-compassion.	Baseline to 2-week follow-up
Repetitive negative thinking	Persistent and Intrusive Negative Thoughts Scale (PINTS). Total scores range from 0 to 20, with higher scores indicating greater repetitive negative thinking.	Baseline to 2-week follow-up
Avoidance	Cognitive avoidance subscale of the Coping Response Inventory (CRI). Total scores range from 0 to 20, with higher scores indicating greater avoidance.	Baseline to 2-week follow-up
Problem-solving	Problem-solving subscale of the Coping Response Inventory (CRI). Total scores range from 0 to 20, with higher scores indicating greater problem-solving.	Baseline to 2-week follow-up
Positive Reappraisal	Positive reappraisal subscale of the Coping Response Inventory (CRI). Total scores range from 0 to 20, with higher scores indicating greater positive reappraisal.	Baseline to 2-week follow-up
Pain intensity	Single item visual analogue scale (0 to 10) of pain intensity drawn from the Brief Pain Inventory (BPI)	Baseline to 2-week follow-up
Pain interference	Single item visual analogue scale (0 to 10) of pain interference ("To what extent has pain interfered with your ability to enjoy life") drawn from the Brief Pain Inventory (BPI)	Baseline to 2-week follow-up
Pain catastrophizing	Single item ("When I feel pain, it is terrible, and I feel it is never going to get any better") drawn from the Pain Catastrophizing Scale (PCS), rated on a scale from 0 to 4.	Baseline to 2-week follow-up
Alcohol use	Daily Drinking Questionnaire (DDQ). Minimum score is 0 and maximum score is not known and depends on how many drinks the participant reports. Higher scores indicate greater alcohol use.	Baseline to 2-week follow-up
Alcohol craving	Single item visual analogue scale (0 to 10) of craving severity	Baseline to 2-week follow-up
Affective self-compassion	Affective Self-Compassion Questionnaire (ASCQ). Total scores range from 0 to 40, with higher scores indicating greater affective self-compassion.	Baseline to 2-week follow-up

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 2000030587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No