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

NCT05109507 | Completed

• 1 other identifier: 2000030587
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

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

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change over time in functional impairment

  Baseline to 2-week follow-up

• State emotional awareness, clarity, and acceptance following negative affect induction

  Immediate post-intervention

• State non-acceptance of emotions

  Immediate post-intervention

• Change over time in emotional awareness, clarity, and acceptance

  Baseline to 2-week follow-up

• Change over time in non-acceptance of emotions

  Baseline to 2-week follow-up

Other Outcomes (11)

• Change in self-compassion

  Baseline to 2-week follow-up

• Repetitive negative thinking

  Baseline to 2-week follow-up

• Avoidance

  Baseline to 2-week follow-up

Study Arms (2)

Visitor Mindset

EXPERIMENTAL

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

Relaxing with Nature

ACTIVE COMPARATOR

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

Interventions

Visitor Mindset BEHAVIORAL

Single-session, self-guided intervention

Visitor Mindset

Relaxing with Nature BEHAVIORAL

Single-session, self-guided intervention

Relaxing with Nature

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• Roos CR, Bricker J, Kiluk B, Trull TJ, Bowen S, Witkiewitz K, Kober H. A smartphone app-based mindfulness intervention to enhance recovery from substance use disorders: Protocol for a pilot feasibility randomized controlled trial. Contemp Clin Trials Commun. 2024 Jul 26;41:101338. doi: 10.1016/j.conctc.2024.101338. eCollection 2024 Oct.

  PMID: 39233850 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 5, 2021
• Study Start: October 18, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

US (1)