Pilot Randomized Trial of Compassionate Care: A Single-Session Web-Based Training in Self-Compassion Among Adults With Stress, Anxiety, and/or Depressive Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 365
- Locations
- 1
- Primary Endpoint
- Change in Stress symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Compassionate Care
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.
Intervention: Compassionate Care (Behavioral)
Relaxing with Nature
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: Relaxing with Nature (Behavioral)
Outcomes
Primary Outcomes
Change in Stress symptoms
Time Frame: 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 Depressive symptoms
Time Frame: 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
Time Frame: 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.
Change in Anxiety symptoms
Time Frame: 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.
Secondary Outcomes
- Change in Mindfulness(Baseline to 2-week follow-up)
- Change in Self-Compassion(Baseline to 2-week follow-up)