Self-Help for Stress Related to COVID-19

NCT04762173 | Completed

• 1 other identifier: STUDY00015766
• Study Type: interventional
• Target: 585
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

Self-help; Internet; Cognitive-behavioral therapy; Positive psychology; COVID-19

Outcome Measures

Primary Outcomes (1)

• Change in stress

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

  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.

Secondary Outcomes (4)

• Change in anxiety

  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.

• Change in depression

  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.

• Change in perceived stress

  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.

• Change in coronavirus-related stress

  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.

Other Outcomes (9)

• Change in screening status for major depressive disorder

  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.

• Change in screening status for generalized anxiety disorder

  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.

• Change in screening status for social anxiety disorder

  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.

Study Arms (2)

Online self-help intervention

EXPERIMENTAL

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.

Device: Online self-help intervention

Care as usual

NO INTERVENTION

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.

Interventions

Online self-help intervention DEVICE

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

Also known as: SilverCloud Health

Online self-help intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Below age 18
• Current participant in separate randomized controlled trial being conducted by this research group examining efficacy of SilverCloud Health interventions

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 18602, United States

Location

Related Publications (1)

• 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.

  PMID: 35351353 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gavin N Rackoff, MS

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 21, 2021
• Study Start: November 6, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)