Single-Session Web-Based Training in Self-Compassion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Randomized Trial of Compassionate Care: A Single-Session Web-Based Training in Self-Compassion Among Adults With Stress, Anxiety, and/or Depressive Symptoms

Conditions
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Stress, Anxiety, Depression

Intervention / Treatment
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* Behavioral: Compassionate Care
* Behavioral: Relaxing with Nature


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compassionate Care<br>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<br>* Single-session web-based program<br>|
| Active Comparator: Relaxing with Nature<br>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<br>* Single-session web-based program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Self-Compassion