Single-Session Web-Based Training in Self-Compassion

NCT05715034 | Completed

• 1 other identifier: 2000033574
• Study Type: interventional
• Target: 365
• 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 Compassionate Care versus a control intervention (nature videos with relaxing music) for adults with moderate-to-severe stress, depression and/or anxiety symptoms.

Conditions

Stress; Anxiety; Depression

Keywords

Randomized controlled trial; Self-Compassion

Outcome Measures

Primary Outcomes (4)

• Change in Stress symptoms

  Perceived Stress Scale (PSS-10). Total scores range from 0 to 40 with higher scores indicating greater stress symptoms

  Baseline to 2-week follow-up

• Change in Anxiety symptoms

  General Anxiety Disorder-7 (GAD-7). Total scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.

  Baseline to 2-week follow-up

• Change in Depressive symptoms

  Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptoms.

  Baseline to 2-week follow-up

• Change in Functional Impairment

  Work and Social Adjustment Scale (WSAS). Total scores range from 0 to 40, with higher scores indicating greater functional impairment.

  Baseline to 2-week follow-up

Secondary Outcomes (2)

• Change in Self-Compassion

  Baseline to 2-week follow-up

• Change in Mindfulness

  Baseline to 2-week follow-up

Study Arms (2)

Compassionate Care

EXPERIMENTAL

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.

Behavioral: Compassionate Care

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. 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

Compassionate Care BEHAVIORAL

Single-session web-based program

Compassionate Care

Relaxing with Nature BEHAVIORAL

Single-session web-based program

Relaxing with Nature

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Fluent in English
• At least moderate stress, anxiety and/or depressive symptoms, as indicated by a score of:
• or higher on the PSS-10, and/or 10 or higher on the GAD-7, and/or 10 or higher on the PHQ-9

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 6, 2023
• Study Start: February 27, 2023
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)