An interventional study of Compassionate Care and Relaxing with Nature in Stress, Anxiety and Depression, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
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.
8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 365 is above the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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 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
Single-session web-based program
Change in Stress symptoms
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
Change in Anxiety symptoms
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
Change in Depressive symptoms
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
Change in Functional Impairment
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
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.
Time frame: 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.
Time frame: Baseline to 2-week follow-up
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yale University