Single-Session Web-Based Training in Self-Compassion

Pilot Randomized Trial of Compassionate Care: A Single-Session Web-Based Training in Self-Compassion Among Adults With Stress, Anxiety, and/or Depressive Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stress; Anxiety
• Intervention / Treatment: Behavioral: Compassionate Care; Behavioral: Relaxing with Nature

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 365
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

• Fail to meet above-listed inclusion criteria
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Compassionate Care; Single-session web-based program
Active Comparator: 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.	Behavioral: Relaxing with Nature; Single-session web-based program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-Compassion	Self-Compassion Scale (SCS). Total scores are the average of each of the subscales, and range from 0 to 5. Higher scores indicate greater self-compassion.	Baseline to 2-week follow-up
Change in Mindfulness	Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness.	Baseline to 2-week follow-up

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): April 17, 2023
• Study Completion (Actual): April 17, 2023

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Self-Compassion
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Depression; Anxiety Disorders
• Other Study ID Numbers: 2000033574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In compliance with HIPAA and Yale Human Investigation Committee standards, any data sets that will be shared will not include any personally identifiable information. Requests for data sharing will be considered within the context of ongoing and planned research being performed within the research group at Yale in order to avoid duplication of effort and overlap in data analysis that might compromise communication of findings. Data to be shared will be de-identified and transmission electronically and securely, as we have done previously with investigators at other institutions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No