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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compassionate Care | Behavioral | Single-session web-based program |
| |
| 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 |
| 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 |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale | New Haven | Connecticut | 06511 | United States |
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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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Relaxing with Nature |
| Behavioral |
Single-session web-based program |
|
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 |