Back to resultsSingle-Session Web-Based Training in Self-Compassion
Primary Purpose
Stress, Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compassionate Care
Relaxing with Nature
Sponsored by
About this trial
This is an interventional treatment trial for Stress focused on measuring Randomized controlled trial, Self-Compassion
Eligibility Criteria
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
Sites / Locations
- Yale
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Compassionate Care
Relaxing with Nature
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Stress symptoms
Perceived Stress Scale (PSS-10). Total scores range from 0 to 40 with higher scores indicating greater stress symptoms
Change in Anxiety symptoms
General Anxiety Disorder-7 (GAD-7). Total scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.
Change in Depressive symptoms
Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptoms.
Change in Functional Impairment
Work and Social Adjustment Scale (WSAS). Total scores range from 0 to 40, with higher scores indicating greater functional impairment.
Secondary Outcome Measures
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.
Change in Mindfulness
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05715034
Brief Title
Single-Session Web-Based Training in Self-Compassion
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
April 17, 2023 (Actual)
Study Completion Date
April 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety, Depression
Keywords
Randomized controlled trial, Self-Compassion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
365 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Compassionate Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Relaxing with Nature
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Compassionate Care
Intervention Description
Single-session web-based program
Intervention Type
Behavioral
Intervention Name(s)
Relaxing with Nature
Intervention Description
Single-session web-based program
Primary Outcome Measure Information:
Title
Change in Stress symptoms
Description
Perceived Stress Scale (PSS-10). Total scores range from 0 to 40 with higher scores indicating greater stress symptoms
Time Frame
Baseline to 2-week follow-up
Title
Change in Anxiety symptoms
Description
General Anxiety Disorder-7 (GAD-7). Total scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.
Time Frame
Baseline to 2-week follow-up
Title
Change in Depressive symptoms
Description
Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptoms.
Time Frame
Baseline to 2-week follow-up
Title
Change in Functional Impairment
Description
Work and Social Adjustment Scale (WSAS). Total scores range from 0 to 40, with higher scores indicating greater functional impairment.
Time Frame
Baseline to 2-week follow-up
Secondary Outcome Measure Information:
Title
Change in Self-Compassion
Description
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.
Time Frame
Baseline to 2-week follow-up
Title
Change in Mindfulness
Description
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness.
Time Frame
Baseline to 2-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Yale
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
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Single-Session Web-Based Training in Self-Compassion
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