Anxiety, Depression, Stress
Conditions
Keywords
Randomized controlled trial, Self-Compassion
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.
Interventions
BEHAVIORALCompassionate Care
Single-session web-based program
BEHAVIORALRelaxing with Nature
Single-session web-based program
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stress symptoms | Baseline to 2-week follow-up | Perceived Stress Scale (PSS-10). Total scores range from 0 to 40 with higher scores indicating greater stress symptoms |
| Change in Anxiety symptoms | Baseline to 2-week follow-up | General Anxiety Disorder-7 (GAD-7). Total scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. |
| Change in Depressive symptoms | Baseline to 2-week follow-up | Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptoms. |
| Change in Functional Impairment | Baseline to 2-week follow-up | Work and Social Adjustment Scale (WSAS). Total scores range from 0 to 40, with higher scores indicating greater functional impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Compassion | Baseline to 2-week follow-up | 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 | Baseline to 2-week follow-up | Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness. |
Countries
United States
Outcome results
None listed