Single-Session Web-Based Training in Self-Compassion

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05715034
Collaborator
(none)
485
2
28

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Compassionate Care
  • Behavioral: Relaxing with Nature
N/A

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
Anticipated Enrollment :
485 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pilot Randomized Trial of Compassionate Care: A Single-Session Web-Based Training in Self-Compassion Among Adults With Stress, Anxiety, and/or Depressive Symptoms
Anticipated Study Start Date :
Feb 8, 2023
Anticipated Primary Completion Date :
Mar 8, 2023
Anticipated Study Completion Date :
Mar 8, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Compassionate Care
Single-session web-based program

Active Comparator: 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.

Behavioral: Relaxing with Nature
Single-session web-based program

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

  3. 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.

  4. 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 Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05715034
Other Study ID Numbers:
  • 2000033574
First Posted:
Feb 6, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yale University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023