Clinical trial NCT04762173: Self-Help for Stress Related to COVID-19
Official title: Self-Help for Stress Related to COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Self-help
Internet
Cognitive-behavioral therapy
Positive psychology
COVID-19
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in stress
timeFrame: 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:
measure: Change in anxiety
timeFrame: 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.
measure: Change in depression
timeFrame: 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.
measure: Change in perceived stress
timeFrame: 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.
measure: Change in coronavirus-related stress
timeFrame: 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:
measure: Change in screening status for major depressive disorder
timeFrame: 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.
measure: Change in screening status for generalized anxiety disorder
timeFrame: 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.
measure: Change in screening status for social anxiety disorder
timeFrame: 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.
measure: Change in screening status for panic disorder
timeFrame: 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.
measure: Change in screening status for anorexia nervosa
timeFrame: 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.
measure: Change in screening status for bulimia nervosa/binge eating disorder
timeFrame: 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.
measure: Change in screening status for insomnia
timeFrame: 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.
measure: Change in screening status for alcohol use disorder
timeFrame: 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.
measure: Change in screening status for posttraumatic stress disorder
timeFrame: 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.
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Gavin N Rackoff, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.