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Completed

NCT Number: NCT04762173

Self-Help for Stress Related to COVID-19

This is a study on internet-based self-help for stress related to the COVID-19 pandemic. College and university students who score in the moderate or higher range on a stress measure during the COVID-19 pandemic will be invited to participate in this study. Participants will be randomly assigned to receive access to an internet-based self-help program for stress resilience and coping with the COVID-19 pandemic or care as usual. Stress and psychosocial symptoms will be assessed via questionnaire at baseline (pre-randomization), one month post-randomization, and three months post-randomization.

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Key information

Conditions

Stress COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 18602, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate or higher stress as assessed using Stress subscale of the Depression Anxiety Stress Scales-Short Form
  • Current student at a college or university in the United States
  • Able to provide consent
  • Proficient in English

Exclusion criteria

  • Below age 18
  • Failure to meet any of above inclusion criteria
  • Current participant in separate randomized controlled trial being conducted by this research group examining efficacy of SilverCloud Health interventions

Treatment and study plan

Online self-help intervention

Device

Access to two online, self-guided programs available on the SilverCloud Health website.

Other names: SilverCloud Health

Primary outcomes

  1. Change in stress

    Time frame: Measured at baseline, one month, and three months. The primary outcome is change in scale scores from baseline to one month. Change from baseline to three months will also be examined as a secondary outcome.

    Stress assessed using the Stress subscale of the Depression, Anxiety, Stress Scales-Short Form (7 of 21 items; self-report; possible range = 0-42)

Secondary outcomes

  1. Change in anxiety

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in scale score from baseline to one month and change in scale score from baseline to three months.

    Anxiety assessed using the Anxiety subscale of the Depression, Anxiety, Stress Scales-Short Form (7 of 21 items; self-report; possible range = 0-42)

  2. Change in depression

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in scale score from baseline to one month and change in scale score from baseline to three months.

    Depression assessed using the Depression subscale of the Depression, Anxiety, Stress Scales-Short Form (7 of 21 items; self-report; possible range = 0-42)

  3. Change in perceived stress

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in scale score from baseline to one month and change in scale score from baseline to three months.

    Perceived stress assessed using the Perceived Stress Scale-10 (10 items, self-report; possible range = 0-40)

  4. Change in coronavirus-related stress

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in subscale scores from baseline to one month and change in subscale scores from baseline to three months.

    Coronavirus-related stress assessed using the COVID Stress Scales (6-item self-report subscales assessing the following forms of coronavirus-related stress: danger, socioeconomic consequences, xenophobia, contamination fears, traumatic stress, compulsive checking; subscale scores range from 0 to 24)

Other outcomes

  1. Change in screening status for major depressive disorder

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in screening status from baseline to one month and change in screening status from baseline to three months.

    Screening for major depressive disorder using the Patient Health Questionnaire-9 (9 items, self-report, possible range = 0-40, probable depression indicated by score of 10 or higher)

  2. Change in screening status for generalized anxiety disorder

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in screening status from baseline to one month and change in screening status from baseline to three months.

    Screening for generalized anxiety disorder using the Generalized Anxiety Disorder Questionnaire-IV (9 items, self-report, probable generalized anxiety disorder indicated if participants endorse all diagnostic criteria)

  3. Change in screening status for social anxiety disorder

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in screening status from baseline to one month and change in screening status from baseline to three months.

    Screening for social anxiety disorder using the Social Phobia Diagnostic Questionnaire (25 items, self-report; probable social anxiety disorder indicated if participants endorse all diagnostic criteria)

  4. Change in screening status for panic disorder

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in screening status from baseline to one month and change in screening status from baseline to three months.

    Screening for panic disorder using Panic Disorder Self-Report (24 items, self-report, probable panic disorder indicated if participants endorse all diagnostic criteria)

  5. Change in screening status for anorexia nervosa

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in screening status from baseline to one month and change in screening status from baseline to three months.

    Screening for anorexia nervosa using Stanford-Washington University Eating Disorder scale (14 items, self-report; probable anorexia nervosa indicated if participants score 59 or higher (out of 100) on weight concerns items and endorse current body mass index ≤ 18.45)

  6. Change in screening status for bulimia nervosa/binge eating disorder

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in screening status from baseline to one month and change in screening status from baseline to three months.

    Screening for bulimia nervosa or binge eating disorder using Stanford-Washington University Eating Disorder scale (14 items, self-report; probable bulimia nervosa or binge eating disorder indicated if participants do not screen positive for probable anorexia nervosa and endorse six or more instances of binge-eating, self-induced vomiting, or diuretic or laxative misuse in the past three months).

  7. Change in screening status for insomnia

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in screening status from baseline to one month and change in screening status from baseline to three months.

    Screening for insomnia using Insomnia Severity Index (7 items, self-report, scores range from 0 to 28; probable insomnia indicated by score of 15 or higher).

  8. Change in screening status for alcohol use disorder

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in screening status from baseline to one month and change in screening status from baseline to three months.

    Screening for alcohol use disorder using Alcohol Use Disorders Identification Test-C (3 items, self-report, scores range from 0 to 12; probable alcohol use disorder indicated by score of 4 or higher for males and 3 or higher for females).

  9. Change in screening status for posttraumatic stress disorder

    Time frame: Measured at baseline, one month, and three months. Outcomes include change in screening status from baseline to one month and change in screening status from baseline to three months.

    Screening for posttraumatic stress disorder using Primary Care PTSD Screen (4 items, self-report, scores range from 0 to 4; probable posttraumatic stress disorder indicated by score of 3 or higher).

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Jul 12, 2021

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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