Clinical trial NCT05109507: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in anxiety and depression symptoms
timeFrame: Baseline to 2-week follow-up
Secondary outcomes:
measure: Change over time in functional impairment
timeFrame: Baseline to 2-week follow-up
measure: State emotional awareness, clarity, and acceptance following negative affect induction
timeFrame: Immediate post-intervention
measure: State non-acceptance of emotions
timeFrame: Immediate post-intervention
measure: Change over time in emotional awareness, clarity, and acceptance
timeFrame: Baseline to 2-week follow-up
measure: Change over time in non-acceptance of emotions
timeFrame: Baseline to 2-week follow-up
measure: Change over time in beliefs about the usefulness of negative emotions
timeFrame: Baseline to 2-week follow-up
measure: Change over time in beliefs about the duration of negative emotions
timeFrame: Baseline to 2-week follow-up
Other outcomes:
measure: Change in self-compassion
timeFrame: Baseline to 2-week follow-up
measure: Repetitive negative thinking
timeFrame: Baseline to 2-week follow-up
measure: Avoidance
timeFrame: Baseline to 2-week follow-up
measure: Problem-solving
timeFrame: Baseline to 2-week follow-up
measure: Positive Reappraisal
timeFrame: Baseline to 2-week follow-up
measure: Pain intensity
timeFrame: Baseline to 2-week follow-up
measure: Pain interference
timeFrame: Baseline to 2-week follow-up
measure: Pain catastrophizing
timeFrame: Baseline to 2-week follow-up
measure: Alcohol use
timeFrame: Baseline to 2-week follow-up
measure: Alcohol craving
timeFrame: Baseline to 2-week follow-up
measure: Affective self-compassion
timeFrame: Baseline to 2-week follow-up
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
References: