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Completed

NCT Number: NCT05715034

Single-Session Web-Based Training in Self-Compassion

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.

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Key information

Conditions

Stress Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compassionate Care

Behavioral

Single-session web-based program

Relaxing with Nature

Behavioral

Single-session web-based program

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Change in Self-Compassion

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2023
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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