Single-Session Web-Based Training in Self-Compassion

NCT ID: NCT05715034

Last Updated: 2023-04-19

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

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2023-04-17

Brief Summary

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Two-arm, parallel group randomized clinical trial conducted via Mturk comparing a single-session web-based intervention called Compassionate Care versus a control intervention (nature videos with relaxing music) for adults with moderate-to-severe stress, depression and/or anxiety symptoms.

Detailed Description

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Procedures include completing: (1) pre-intervention baseline assessment; (2) one of two single-session web-based intervention (approximately 30 to 45 minutes each); (3) a brief post-intervention survey; and (4) a 2-week follow-up assessment.

Conditions

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Stress Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Compassionate Care

Single-session, self-guided web-based intervention (\~45 minutes) hosted on Qualtrics with animated videos, audio-guided exercises, graphics, text-based material, and interactive questions. This intervention is designed to teach participants about mindfulness and self-compassion.

Group Type EXPERIMENTAL

Compassionate Care

Intervention Type BEHAVIORAL

Single-session web-based program

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. 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 web-based program

Interventions

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Compassionate Care

Single-session web-based program

Intervention Type BEHAVIORAL

Relaxing with Nature

Single-session web-based program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Fluent in English
* At least moderate stress, anxiety and/or depressive symptoms, as indicated by a score of:

14 or higher on the PSS-10, and/or 10 or higher on the GAD-7, and/or 10 or higher on the PHQ-9

* Do not pass attention/data quality checks in initial screening or study assessments, including:
* 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 an average of 1.5 seconds per question for the baseline survey assessment OR who fail all three attention check questions in the baseline survey, indicating very careless, random, inattentive and/or hasty responding
* Exit the study prior to condition randomization
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yale

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2000033574

Identifier Type: -

Identifier Source: org_study_id

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