Self-Help for Stress Related to COVID-19

Not Applicable

Completed

• Conditions: Stress
• Interventions: Device: Online self-help intervention

• Registration Number: NCT04762173
• Lead Sponsor: Penn State University

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 available

Study Timeline

• Study Start: 2020-11-06
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 585

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online self-help intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in stress	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 Outcome Measures

Name	Time	Method
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.	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	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	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	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)

Trial Locations

Locations (1)

The Pennsylvania State University; 🇺🇸 University Park, Pennsylvania, United States