Self-Help for Stress Related to COVID-19

July 9, 2021 updated by: Michelle G. Newman, Penn State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
585

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 18602
        • The Pennsylvania State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Online self-help intervention
Access to two online, self-guided programs available on the SilverCloud Health website.
Other Names:
  • SilverCloud Health
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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
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)
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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 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)
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 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)
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 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).
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 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).
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 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).
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 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).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gavin N Rackoff, MS, The Pennsylvania State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00015766

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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