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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05109507
• Other study ID #: 2000030587
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Visitor Mindset
Single-session, self-guided intervention
• Relaxing with Nature
Single-session, self-guided intervention

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Alcohol craving	Single item visual analogue scale (0 to 10) of craving severity	Baseline to 2-week follow-up
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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