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

NCT ID: NCT05109507

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2021-12-01

Brief Summary

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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

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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.

Conditions

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Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Visitor Mindset

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.

Group Type EXPERIMENTAL

Visitor Mindset

Intervention Type BEHAVIORAL

Single-session, self-guided intervention

Relaxing with Nature

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.

Group Type ACTIVE_COMPARATOR

Relaxing with Nature

Intervention Type BEHAVIORAL

Single-session, self-guided intervention

Interventions

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Visitor Mindset

Single-session, self-guided intervention

Intervention Type BEHAVIORAL

Relaxing with Nature

Single-session, self-guided intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Corey Roos

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39233850 (View on PubMed)

Other Identifiers

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2000030587

Identifier Type: -

Identifier Source: org_study_id