Self-Help for Stress Related to COVID-19

• ClinicalTrials.gov Identifier: NCT04762173
• Recruitment Status: Completed
• First Posted: February 21, 2021
• Last Update Posted: July 12, 2021
• Sponsor: Penn State University
• Information provided by (Responsible Party): Michelle G. Newman, Penn State University

Tracking Information

• First Submitted Date: February 15, 2021
• First Posted Date: February 21, 2021
• Last Update Posted Date: July 12, 2021
• Actual Study Start Date: November 6, 2020
• Actual Primary Completion Date: May 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 18, 2021)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 18, 2021)

• 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)
• 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)
• 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)
• 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)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 18, 2021)

• 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)
• 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)
• 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)
• 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)
• 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)
• 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).
• 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).
• 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).
• 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).

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Self-Help for Stress Related to COVID-19
• Official Title: Self-Help for Stress Related to COVID-19
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stress

Intervention

Device: Online self-help intervention

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

Other Name: SilverCloud Health

Study Arms

• Experimental: Online self-help intervention
  Participants are provided access to two online self-help programs provided by SilverCloud Health. One program is designed to support general stress resilience using principles and techniques from positive psychology and cognitive-behavioral therapy. The other program is designed to support coping with pandemic-related stressors using psychoeducation and cognitive-behavioral therapy and grief therapy principles. Participants have access to both programs and can proceed through them in the order and pace of their choosing. The online self-help intervention is fully self-guided.
  Intervention: Device: Online self-help intervention
• No Intervention: Care as usual
  Participants are provided information about how to contact the counseling center at their college and/or in the local community using the phone number and website of their counseling center (if available), as well as the Substance Abuse and Mental Health Services Administration treatment locator.

• Publications *: Rackoff GN, Fitzsimmons-Craft EE, Taylor CB, Eisenberg D, Wilfley DE, Newman MG. A Randomized Controlled Trial of Internet-Based Self-Help for Stress During the COVID-19 Pandemic. J Adolesc Health. 2022 Aug;71(2):157-163. doi: 10.1016/j.jadohealth.2022.01.227. Epub 2022 Feb 4.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 6, 2021): 585
• Original Actual Enrollment (submitted: February 18, 2021): 584
• Actual Study Completion Date: May 31, 2021
• Actual Primary Completion Date: May 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04762173
• Other Study ID Numbers: STUDY00015766
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Michelle G. Newman, Penn State University
• Original Responsible Party: Gavin N. Rackoff, Penn State University, Graduate Student
• Current Study Sponsor: Penn State University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gavin N Rackoff, MS; The Pennsylvania State University

• PRS Account: Penn State University
• Verification Date: July 2021