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

Yale University530 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

530

Conditions

Depression Anxiety

Interventions

Visitor MindsetBEHAVIORAL

Single-session, self-guided intervention

Relaxing with NatureBEHAVIORAL

Single-session, self-guided intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale University School of Medicine

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 2-week follow-up

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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