Single-Session Web-Based Training in Self-Compassion

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05715034
• Other study ID #: 2000033574
• Status: Completed
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: April 17, 2023

Study information

• Verified date: April 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: April 17, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Stress

Intervention

Behavioral:
• Compassionate Care
Single-session web-based program
• Relaxing with Nature
Single-session web-based program

Locations

Country	Name	City	State
United States	Yale	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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