Back to resultsSingle-Session Intervention Targeting Emotional Awareness, Clarity, and Acceptance to Reduce Depression/Anxiety
Primary Purpose
Depression, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visitor Mindset
Relaxing with Nature
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Visitor Mindset
Relaxing with Nature
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05109507
Brief Title
Single-Session Intervention Targeting Emotional Awareness, Clarity, and Acceptance to Reduce Depression/Anxiety
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
530 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visitor Mindset
Arm Type
Experimental
Arm Description
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.
Arm Title
Relaxing with Nature
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Visitor Mindset
Intervention Description
Single-session, self-guided intervention
Intervention Type
Behavioral
Intervention Name(s)
Relaxing with Nature
Intervention Description
Single-session, self-guided intervention
Primary Outcome Measure Information:
Title
Change in anxiety and depression symptoms
Description
Patient Health Questionnaire-Anxiety Depression Scale (PHQ-ADS). Total scores range from 0 to 27, with higher scores indicating greater anxiety/depression symptoms.
Time Frame
Baseline to 2-week follow-up
Secondary Outcome Measure Information:
Title
Change over time in functional impairment
Description
Work and Social Adjustment Scale (WSAS). Total scores range from 0 to 40, with higher scores indicating greater functional impairment.
Time Frame
Baseline to 2-week follow-up
Title
State emotional awareness, clarity, and acceptance following negative affect induction
Description
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.
Time Frame
Immediate post-intervention
Title
State non-acceptance of emotions
Description
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.
Time Frame
Immediate post-intervention
Title
Change over time in emotional awareness, clarity, and acceptance
Description
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.
Time Frame
Baseline to 2-week follow-up
Title
Change over time in non-acceptance of emotions
Description
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.
Time Frame
Baseline to 2-week follow-up
Title
Change over time in beliefs about the usefulness of negative emotions
Description
Emotion Beliefs Questionnaire (EBQ). Total scores range from 0 to 16, with higher scores indicating greater beliefs that emotions are not useful or harmful
Time Frame
Baseline to 2-week follow-up
Title
Change over time in beliefs about the duration of negative emotions
Description
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)
Time Frame
Baseline to 2-week follow-up
Other Pre-specified Outcome Measures:
Title
Change in self-compassion
Description
Self-Compassion Scale (SCS). Total scores range from 0 to 48, with higher scores indicating greater self-compassion.
Time Frame
Baseline to 2-week follow-up
Title
Repetitive negative thinking
Description
Persistent and Intrusive Negative Thoughts Scale (PINTS). Total scores range from 0 to 20, with higher scores indicating greater repetitive negative thinking.
Time Frame
Baseline to 2-week follow-up
Title
Avoidance
Description
Cognitive avoidance subscale of the Coping Response Inventory (CRI). Total scores range from 0 to 20, with higher scores indicating greater avoidance.
Time Frame
Baseline to 2-week follow-up
Title
Problem-solving
Description
Problem-solving subscale of the Coping Response Inventory (CRI). Total scores range from 0 to 20, with higher scores indicating greater problem-solving.
Time Frame
Baseline to 2-week follow-up
Title
Positive Reappraisal
Description
Positive reappraisal subscale of the Coping Response Inventory (CRI). Total scores range from 0 to 20, with higher scores indicating greater positive reappraisal.
Time Frame
Baseline to 2-week follow-up
Title
Pain intensity
Description
Single item visual analogue scale (0 to 10) of pain intensity drawn from the Brief Pain Inventory (BPI)
Time Frame
Baseline to 2-week follow-up
Title
Pain interference
Description
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)
Time Frame
Baseline to 2-week follow-up
Title
Pain catastrophizing
Description
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.
Time Frame
Baseline to 2-week follow-up
Title
Alcohol use
Description
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.
Time Frame
Baseline to 2-week follow-up
Title
Alcohol craving
Description
Single item visual analogue scale (0 to 10) of craving severity
Time Frame
Baseline to 2-week follow-up
Title
Affective self-compassion
Description
Affective Self-Compassion Questionnaire (ASCQ). Total scores range from 0 to 40, with higher scores indicating greater affective self-compassion.
Time Frame
Baseline to 2-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Single-Session Intervention Targeting Emotional Awareness, Clarity, and Acceptance to Reduce Depression/Anxiety
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